ROYAL-1: A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins

• Sponsor: NeuroBo Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02634151
• Collaborator: (none)
• Enrollment: 105
• Locations: 24
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesteremia	Drug: Gemcabene; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.	Drug: Placebo; Three placebo tablets administered orally once daily for 12 weeks.
Experimental: Gemcabene 600 mg Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.	Drug: Gemcabene; Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in LDL-C at Week 12 [Baseline, Week 12]

Secondary Outcome Measures

1. Percent Change From Baseline in LDL-C by Statin Intensity Stratum [Baseline, Week 12]

   The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity & moderate intensity based on their statin doses.

2. Change From Baseline in LDL-C [Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12]

3. Percent Change From Baseline in LDL-C [Baseline, average of weeks 8 and 12]

4. Percent Change From Baseline in Non-HDL-C [Baseline, Weeks 2, 4, 8 and 12]

5. Change From Baseline in Non-HDL-C [Baseline, Weeks 2, 4, 8 and 12]

6. Percent Change From Baseline in TC [Baseline, Weeks 2, 4, 8 and 12]

7. Change From Baseline in TC [Baseline, Weeks 2, 4, 8 and 12]

8. Percent Change From Baseline in TG [Baseline, Weeks 2, 4, 8 and 12]

9. Change From Baseline in TG [Baseline, Weeks 2, 4, 8 and 12]

10. Percent Change From Baseline in VLDL-C [Baseline, Weeks 2, 4, 8 and 12]

11. Change From Baseline in VLDL-C [Baseline, Weeks 2, 4, 8 and 12]

12. Percent Change From Baseline in HDL-C [Baseline, Weeks 2, 4, 8 and 12]

13. Change From Baseline in HDL-C [Baseline, Weeks 2, 4, 8 and 12]

14. Number of Participants Achieving LDL-C Reduction of ≥10% [Weeks 4, 8 and 12]

15. Number of Participants Achieving LDL-C Reduction of ≥15% [Weeks 4, 8 and 12]

16. Number of Participants Achieving LDL-C Reduction of ≥20% [Weeks 4, 8 and 12]

17. Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L) [Weeks 4, 8 and 12]

18. Percent Change From Baseline in Apolipoprotein B [Baseline, Weeks 4, 8 and 12]

19. Change From Baseline in Apolipoprotein B [Baseline, Weeks 4, 8 and 12]

20. Percent Change From Baseline in Apolipoprotein A-I [Baseline, Weeks 4, 8 and 12]

21. Change From Baseline in Apolipoprotein A-I [Baseline, Weeks 4, 8 and 12]

22. Percent Change From Baseline in Apolipoprotein A-II [Baseline, Weeks 4, 8 and 12]

23. Change From Baseline in Apolipoprotein A-II [Baseline, Weeks 4, 8 and 12]

24. Percent Change From Baseline in Apolipoprotein C-II [Baseline, Weeks 4, 8 and 12]

25. Change From Baseline in Apolipoprotein C-II [Baseline, Weeks 4, 8 and 12]

26. Percent Change From Baseline in Apolipoprotein C-III [Baseline, Weeks 4, 8 and 12]

27. Change From Baseline in Apolipoprotein C-III [Baseline, Weeks 4, 8 and 12]

28. Percent Change From Baseline in Apolipoprotein E [Baseline, Weeks 4, 8 and 12]

29. Change From Baseline in Apolipoprotein E [Baseline, Weeks 4, 8 and 12]

30. Percent Change From Baseline in Lipoprotein(a) [Baseline, Weeks 4, 8 and 12]

31. Change From Baseline in Lipoprotein(a) [Baseline, Weeks 4, 8 and 12]

32. Percent Change From Baseline in High-sensitivity C-reactive Protein [Baseline, Week 12]

33. Change From Baseline in High-sensitivity C-reactive Protein [Baseline, Week 12]

34. Percent Change From Baseline in Fibrinogen [Baseline, Week 12]

35. Change From Baseline in Fibrinogen [Baseline, Week 12]

36. Percent Change From Baseline in Serum Amyloid A [Baseline, Week 12]

37. Change From Baseline in Serum Amyloid A [Baseline, Week 12]

38. Percent Change From Baseline in Adiponectin [Baseline, Week 12]

39. Change From Baseline in Adiponectin [Baseline, Week 12]

40. Change From Baseline in Framingham Risk Score [Baseline, Week 12]

    Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedures;

2. Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of consent;

3. Currently on a stable, low-fat, low-cholesterol diet in combination with allowed statin doses as described in Table 1, with or without ezetimibe 10 mg QD for at least 12 weeks prior to the Screening Visit;

4. Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;

5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;

6. Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2

7. Subjects with Type 2 diabetes who take anti-hyperglycemic agents must be on a stable regimen for at least 3 months, with no planned changes in medications for the study duration.

Exclusion Criteria

1. Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) > 2x ULN (upper limit of normal), total bilirubin > 1.5x ULN, or alkaline phosphate > 2x ULN based on appropriate age and gender normal values. Subjects with bilirubin > 1.5x ULN and a history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;

2. Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;

3. Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;

4. Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;

5. Moderate to severe renal insufficiency define as an estimated GFR < 60mL/min/1.73m (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or Screening Visit;

6. Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria) confirmed by reflexive urine protein:creatinine ration testing;

7. Uncontrolled thyroid disease; hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5x ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to Screening;

8. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c value > 8.5% based on results from the Pre-Screening or Screening Visit, or taking a thiazolidinedione (i.e. pioglitazone or rosiglitazone);

9. New York Heart Association Class III or IV heart failure;

10. Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit. Subjects with adequately treated stable angina, per Investigator assessment, may be included;

11. Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior to dosing ECG (QTcF > 450 msec for men and > 470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;

12. Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;

13. Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;

14. Inadequate wash-out of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4 weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile acid sequestrants (4 weeks prior to the Screening Visit);

15. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;

16. Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4 inhibitors as described in Appendix D;

17. History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);

18. Previously treated with gemcabene (CI-1027), participation in another clinical study of an investigational agent or device concurrently or within 1 month prior the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit;

19. Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Research Associates, Inc.	Birmingham	Alabama	United States	35205
2	Westside Medical Associates of Los Angeles	Beverly Hills	California	United States	90211
3	National Research Institute	Huntington Park	California	United States	90255
4	National Research Institute	Los Angeles	California	United States	90057
5	Atlantic Clinical Research Collaborative- Cardiology	Atlantis	Florida	United States	33462
6	Excel Medical Clinical Trials	Boca Raton	Florida	United States	33434
7	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
8	Health Awareness, Inc.	Jupiter	Florida	United States	33458
9	Meridien Research, Inc.	Maitland	Florida	United States	32751
10	Progressive Medical Research	Port Orange	Florida	United States	32127
11	Varkey Medical	Tampa	Florida	United States	33626
12	Evanston Premier Healthcare Research, LLC	Evanston	Illinois	United States	60201
13	Midwest Institute for Clinical Research	Indianapolis	Indiana	United States	46260
14	L-MARC	Louisville	Kentucky	United States	40213
15	Mid-Hudson Medical Research	New Windsor	New York	United States	12553
16	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
17	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45219
18	Sentral Clinical Research Services	Cincinnati	Ohio	United States	45236
19	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45246
20	Green and Seidner Family Practice Associates	Lansdale	Pennsylvania	United States	19446
21	Associates in Medicine	Houston	Texas	United States	77027
22	Diagnostics Research Grup	San Antonio	Texas	United States	78229
23	Sugar Lakes Family Practice	Sugar Land	Texas	United States	77479
24	National Research Institute	Richmond	Virginia	United States

Sponsors and Collaborators

• NeuroBo Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Jul 10, 2017
• Study Protocol - Oct 5, 2016

More Information

Publications

None provided.

• Responsible Party: NeuroBo Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT02634151
• Other Study ID Numbers: GEM-301
• First Posted: Dec 17, 2015
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by NeuroBo Pharmaceuticals Inc.: LDL-C; Lipid Regulator
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

Participant Flow

Pre-assignment Detail	Participants who had heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) and were on a statin therapy were enrolled in this study.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Period Title: Overall Study
STARTED	53	52
Full Analysis Set	53	52
Safety Set	54	51
COMPLETED	52	50
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Gemcabene 600 mg	Placebo	Total
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.	Total of all reporting groups
Overall Participants	53	52	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.7 (9.30)	59.0 (9.67)	60.8 (9.62)
Sex: Female, Male (Count of Participants)
Female	29 54.7%	27 51.9%	56 53.3%
Male	24 45.3%	25 48.1%	49 46.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 18.9%	6 11.5%	16 15.2%
Not Hispanic or Latino	43 81.1%	45 86.5%	88 83.8%
Unknown or Not Reported	0 0%	1 1.9%	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.9%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	1 1.9%	0 0%	1 1%
Black or African American	8 15.1%	12 23.1%	20 19%
White	43 81.1%	38 73.1%	81 77.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 3.8%	2 1.9%
Low-density lipoprotein cholesterol (LDL-C) (Milligram per deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milligram per deciliter (mg/dL)]	133.83 (24.107)	126.49 (28.101)	130.20 (26.294)
Non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	162.17 (29.664)	154.31 (32.796)	158.28 (31.353)
Total Cholesterol (TC) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	216.68 (28.643)	206.16 (31.848)	211.47 (30.586)
Triglycerides (TG) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	141.57 (60.696)	138.80 (65.088)	140.20 (62.621)
High-density lipoprotein cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	54.51 (14.594)	51.86 (13.097)	53.20 (13.870)
Very low-density lipoprotein cholesterol (VLDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	28.34 (12.114)	27.82 (13.048)	28.08 (12.527)
LDL-C by Statin intensity stratum (mg/dL) [Mean (Standard Deviation) ]
Moderate-intensity	128.91 (18.742)	124.54 (28.104)	126.76 (23.681)
High-intensity	139.34 (28.356)	128.60 (28.521)	133.97 (28.665)
Apolipoprotein B (ApoB) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	108.0 (19.61)	100.1 (22.22)	104.1 (21.22)
Apolipoprotein A-I (ApoA-I) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	155.3 (22.14)	148.8 (25.45)	152.1 (23.94)
Apolipoprotein A-II (ApoA-II) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	36.9 (5.38)	36.0 (5.86)	36.5 (5.62)
Apolipoprotein C-II (ApoC-II) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	5.5 (2.45)	5.5 (2.65)	5.5 (2.54)
Apolipoprotein C-III (ApoC-III) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	10.9 (3.40)	10.7 (3.69)	10.8 (3.53)
Apolipoprotein E (ApoE) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	4.3 (0.97)	4.2 (1.08)	4.3 (1.02)
High-sensitivity C-reactive protein (hsCRP) (milligram per Liter (mg/L)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligram per Liter (mg/L)]	2.93 (2.792)	3.91 (4.779)	3.42 (3.916)
Fibrinogen (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	453.5 (113.26)	460.7 (92.22)	457.1 (102.95)
Lipoprotein(a) (Nanomole per liter (nmol/L)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Nanomole per liter (nmol/L)]	104.4 (123.23)	113.8 (102.59)	109.1 (113.03)
Adiponectin (Microgram per milliliter (μg/mL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Microgram per milliliter (μg/mL)]	6.8 (4.90)	6.6 (3.98)	6.7 (4.45)
Serum amyloid A (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	5.8 (3.20)	8.6 (11.01)	7.2 (816)
Framingham Risk Score (Percentage (%)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage (%)]	18.109 (13.8630)	15.381 (11.4957)	16.758 (12.7583)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in LDL-C at Week 12
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by Last observation carried forward (LOCF).

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Least Squares Mean (Standard Error) [Percent Change]	-16.03 (3.234)	-4.98 (3.330)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0057
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.05
	Confidence Interval	(2-Sided) 95%; -18.81 to -3.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent Change From Baseline in LDL-C by Statin Intensity Stratum
Description	The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity & moderate intensity based on their statin doses.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable in each category.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Moderate intensity	-19.58 (4.739)	-8.94 (4.766)
High intensity	-13.05 (4.732)	-1.25 (4.943)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	High-Intensity.
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0648
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.80
	Confidence Interval	(2-Sided) 95%; -24.35 to 0.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Moderate Intensity.
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0398
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.64
	Confidence Interval	(2-Sided) 95%; -20.77 to -0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in LDL-C
Time Frame	Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-25.69 (3.731)	-15.60 (3.842)
Week 4	-20.72 (3.958)	-11.32 (4.076)
Week 8	-17.97 (4.172)	-18.86 (4.296)
Week 12	-20.40 (4.059)	-7.77 (4.180)
Average of week 8 and 12	-19.19 (3.717)	-13.32 (3.827)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0275
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.09
	Confidence Interval	(2-Sided) 95%; -19.04 to -1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4.
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0524
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-9.40
	Confidence Interval	(2-Sided) 95%; -18.90 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.8602
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; -9.12 to 10.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0115
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.63
	Confidence Interval	(2-Sided) 95%; -22.37 to -2.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Average of week 8 and 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1945
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-5.87
	Confidence Interval	(2-Sided) 95%; -14.79 to 3.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percent Change From Baseline in LDL-C
Time Frame	Baseline, average of weeks 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Least Squares Mean (Standard Error) [Percent Change]	-15.15 (2.921)	-9.27 (3.008)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0991
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-5.88
	Confidence Interval	(2-Sided) 95%; -12.89 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percent Change From Baseline in Non-HDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-17.60 (2.397)	-10.01 (2.461)
Week 4	-13.27 (2.664)	-3.71 (2.735)
Week 8	-12.35 (2.831)	-11.41 (2.907)
Week 12	-14.48 (2.860)	-3.79 (2.936)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Other
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0101
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-7.58
	Confidence Interval	(2-Sided) 95%; -13.32 to -1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0037
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-9.56
	Confidence Interval	(2-Sided) 95%; -15.94 to -3.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.7839
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.94
	Confidence Interval	(2-Sided) 95%; -7.72 to 5.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.69
	Confidence Interval	(2-Sided) 95%; -17.53 to -3.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Non-HDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-29.21 (4.088)	-16.55 (4.197)
Week 4	-21.88 (4.318)	-6.33 (4.433)
Week 8	-19.45 (4.551)	-18.86 (4.673)
Week 12	-23.21 (4.451)	-6.62 (4.570)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0117
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.66
	Confidence Interval	(2-Sided) 95%; -22.45 to -2.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0036
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-15.55
	Confidence Interval	(2-Sided) 95%; -25.88 to -5.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9147
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -11.48 to 10.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0026
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-16.59
	Confidence Interval	(2-Sided) 95%; -27.24 to -5.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percent Change From Baseline in TC
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-14.10 (1.923)	-7.97 (1.989)
Week 4	-10.35 (2.136)	-2.62 (2.209)
Week 8	-8.77 (2.236)	-8.88 (2.313)
Week 12	-9.79 (2.161)	-2.90 (2.235)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0101
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.13
	Confidence Interval	(2-Sided) 95%; -10.77 to -1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0036
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-7.73
	Confidence Interval	(2-Sided) 95%; -12.89 to -2.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9653
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -5.27 to 5.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0101
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.89
	Confidence Interval	(2-Sided) 95%; -12.10 to -1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in TC
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-30.47 (4.331)	-17.73 (4.479)
Week 4	-22.37 (4.514)	-6.08 (4.669)
Week 8	-18.10 (4.741)	-19.68 (4.903)
Week 12	-20.90 (4.500)	-6.92 (4.654)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0173
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.74
	Confidence Interval	(2-Sided) 95%; -23.19 to -2.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0038
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-16.29
	Confidence Interval	(2-Sided) 95%; -27.17 to -5.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.7846
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 95%; -9.85 to 13.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0121
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-13.98
	Confidence Interval	(2-Sided) 95%; -24.83 to -3.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percent Change From Baseline in TG
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-10.58 (4.251)	2.64 (4.342)
Week 4	-6.28 (4.706)	17.31 (4.807)
Week 8	-4.94 (3.743)	1.76 (3.823)
Week 12	-8.22 (5.245)	7.42 (5.356)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0108
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-13.32
	Confidence Interval	(2-Sided) 95%; -23.32 to -3.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-23.60
	Confidence Interval	(2-Sided) 95%; -34.78 to -12.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1376
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.71
	Confidence Interval	(2-Sided) 95%; -15.60 to 2.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0144
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-15.64
	Confidence Interval	(2-Sided) 95%; -28.10 to -3.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in TG
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-18.88 (6.322)	0.65 (6.457)
Week 4	-6.08 (7.132)	27.56 (7.284)
Week 8	-8.17 (5.238)	0.16 (5.350)
Week 12	-15.94 (10.194)	13.64 (10.412)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0113
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-19.53
	Confidence Interval	(2-Sided) 95%; -34.55 to -4.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-33.64
	Confidence Interval	(2-Sided) 95%; -50.58 to -16.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1873
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-8.33
	Confidence Interval	(2-Sided) 95%; -20.77 to 4.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0172
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-29.58
	Confidence Interval	(2-Sided) 95%; -53.80 to -5.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Percent Change From Baseline in VLDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-10.55 (4.104)	0.97 (4.192)
Week 4	-6.63 (4.632)	16.38 (4.731)
Week 8	-4.69 (3.687)	1.74 (3.765)
Week 12	-7.69 (4.155)	3.94 (4.243)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0210
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.52
	Confidence Interval	(2-Sided) 95%; -21.27 to -1.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-23.01
	Confidence Interval	(2-Sided) 95%; -34.02 to -12.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1483
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.43
	Confidence Interval	(2-Sided) 95%; -15.19 to 2.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0214
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.63
	Confidence Interval	(2-Sided) 95%; -21.50 to -1.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in VLDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-3.64 (1.124)	-0.69 (1.148)
Week 4	-1.27 (1.371)	5.02 (1.400)
Week 8	-1.56 (1.034)	0.01 (1.056)
Week 12	-2.89 (1.279)	1.11 (1.306)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0308
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.95
	Confidence Interval	(2-Sided) 95%; -5.62 to -0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.30
	Confidence Interval	(2-Sided) 95%; -9.56 to -3.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2056
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.58
	Confidence Interval	(2-Sided) 95%; -4.03 to 0.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0103
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-4.00
	Confidence Interval	(2-Sided) 95%; -7.04 to -0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Percent Change From Baseline in HDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-2.73 (1.771)	-0.60 (1.821)
Week 4	-0.39 (1.888)	2.01 (1.941)
Week 8	2.34 (2.112)	0.37 (2.171)
Week 12	3.86 (2.129)	1.08 (2.189)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3193
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.13
	Confidence Interval	(2-Sided) 95%; -6.36 to 2.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2932
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.40
	Confidence Interval	(2-Sided) 95%; -6.91 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.4383
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.98
	Confidence Interval	(2-Sided) 95%; -3.06 to 7.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2814
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.78
	Confidence Interval	(2-Sided) 95%; -2.31 to 7.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in HDL-C
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 2	-1.33 (0.964)	-0.41 (0.991)
Week 4	-0.48 (1.004)	0.65 (1.033)
Week 8	1.35 (1.099)	0.11 (1.130)
Week 12	2.22 (1.182)	0.62 (1.216)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 2
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.4278
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.92
	Confidence Interval	(2-Sided) 95%; -3.23 to 1.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.3529
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -3.53 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.3522
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95%; -1.39 to 3.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2635
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.60
	Confidence Interval	(2-Sided) 95%; -1.22 to 4.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Number of Participants Achieving LDL-C Reduction of ≥10%
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	33 62.3%	22 42.3%
Week 8	34 64.2%	29 55.8%
Week 12	35 66%	23 44.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0464
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.23
	Confidence Interval	(2-Sided) 95%; 1.01 to 4.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.5278
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95%; 0.58 to 2.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0359
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.36
	Confidence Interval	(2-Sided) 95%; 1.06 to 5.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Number of Participants Achieving LDL-C Reduction of ≥15%
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	28 52.8%	16 30.8%
Week 8	29 54.7%	22 42.3%
Week 12	35 66%	15 28.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0268
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.50
	Confidence Interval	(2-Sided) 95%; 1.11 to 5.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2755
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.55
	Confidence Interval	(2-Sided) 95%; 0.70 to 3.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.74
	Confidence Interval	(2-Sided) 95%; 2.05 to 10.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Number of Participants Achieving LDL-C Reduction of ≥20%
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	25 47.2%	11 21.2%
Week 8	19 35.8%	14 26.9%
Week 12	22 41.5%	10 19.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0079
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.26
	Confidence Interval	(2-Sided) 95%; 1.36 to 7.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.4002
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95%; 0.62 to 3.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0142
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.09
	Confidence Interval	(2-Sided) 95%; 1.25 to 7.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	21 39.6%	13 25%
Week 8	20 37.7%	22 42.3%
Week 12	21 39.6%	15 28.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0115
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.70
	Confidence Interval	(2-Sided) 95%; 1.34 to 10.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.7566
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.48 to 2.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0298
	Comments
	Method	Regression, Logistic
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.96
	Confidence Interval	(2-Sided) 95%; 1.11 to 7.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein B
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	-8.7 (2.81)	1.8 (2.89)
Week 8	-9.8 (2.53)	-5.5 (2.60)
Week 12	-10.5 (2.79)	1.0 (2.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0029
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.4
	Confidence Interval	(2-Sided) 95%; -17.2 to -3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1666
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-4.3
	Confidence Interval	(2-Sided) 95%; -10.4 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0010
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.5
	Confidence Interval	(2-Sided) 95%; -18.2 to -4.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline in Apolipoprotein B
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	-10.6 (2.74)	0.1 (2.82)
Week 8	-11.1 (2.64)	-7.3 (2.72)
Week 12	-12.0 (2.86)	-0.4 (2.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0018
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.7
	Confidence Interval	(2-Sided) 95%; -17.3 to -4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2437
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -10.1 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.6
	Confidence Interval	(2-Sided) 95%; -18.5 to -4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein A-I
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	3.0 (1.45)	3.7 (1.51)
Week 8	4.6 (1.53)	3.8 (1.59)
Week 12	4.7 (1.60)	2.8 (1.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.6832
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -4.2 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.6740
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -2.9 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.3379
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -2.0 to 5.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Change From Baseline in Apolipoprotein A-I
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	3.6 (2.14)	4.4 (2.22)
Week 8	6.5 (2.36)	4.8 (2.45)
Week 12	6.9 (2.50)	3.3 (2.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.7753
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -5.9 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.5472
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -3.9 to 7.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2406
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; -2.4 to 9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein A-II
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	52	52
Week 4	2.1 (1.49)	1.9 (1.54)
Week 8	3.8 (1.84)	-1.4 (1.90)
Week 12	3.7 (1.80)	-0.9 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9028
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -3.3 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0199
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; 0.8 to 9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0369
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.6
	Confidence Interval	(2-Sided) 95%; 0.3 to 8.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Change From Baseline in Apolipoprotein A-II
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	52	52
Week 4	0.5 (0.54)	0.4 (0.56)
Week 8	1.1 (0.69)	-0.8 (0.71)
Week 12	0.9 (0.66)	-0.7 (0.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9110
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -1.2 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0243
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 0.3 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0388
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.1 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein C-II
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	20.0 (5.34)	13.1 (5.46)
Week 8	30.7 (6.95)	3.9 (7.10)
Week 12	27.3 (7.07)	7.2 (7.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2799
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; -5.7 to 19.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0018
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	26.8
	Confidence Interval	(2-Sided) 95%; 10.2 to 43.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0197
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	20.1
	Confidence Interval	(2-Sided) 95%; 3.3 to 36.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Secondary Outcome

Title	Change From Baseline in Apolipoprotein C-II
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	0.5 (0.19)	0.00 (0.20)
Week 8	0.8 (0.24)	-0.3 (0.25)
Week 12	0.8 (0.27)	0.00 (0.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0179
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.1 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.5 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0095
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.2 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein C-III
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	0.4 (3.61)	12.6 (3.69)
Week 8	2.0 (3.56)	1.8 (3.64)
Week 12	3.5 (4.32)	9.7 (4.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0057
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.2
	Confidence Interval	(2-Sided) 95%; -20.8 to -3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9665
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -8.3 to 8.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2358
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.2
	Confidence Interval	(2-Sided) 95%; -16.4 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

28. Secondary Outcome

Title	Change From Baseline in Apolipoprotein C-III
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	0.0 (0.39)	1.4 (0.40)
Week 8	0.0 (0.38)	0.0 (0.38)
Week 12	0.3 (0.44)	0.9 (0.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0048
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -2.3 to -0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9064
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.9 to 0.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2505
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.7 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

29. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein E
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	-6.7 (2.86)	9.1 (2.94)
Week 8	-7.3 (2.89)	-0.1 (2.97)
Week 12	-7.8 (3.16)	7.5 (3.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-15.8
	Confidence Interval	(2-Sided) 95%; -22.6 to -9.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0406
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -14.0 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-15.3
	Confidence Interval	(2-Sided) 95%; -22.8 to -7.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

30. Secondary Outcome

Title	Change From Baseline in Apolipoprotein E
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	-0.3 (0.11)	0.3 (0.12)
Week 8	-0.3 (0.12)	-0.1 (0.13)
Week 12	-0.4 (0.15)	0.3 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0771
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

31. Secondary Outcome

Title	Percent Change From Baseline in Lipoprotein(a)
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	3.5 (4.61)	-5.1 (4.72)
Week 8	3.9 (3.94)	-4.0 (4.03)
Week 12	4.2 (5.18)	0.1 (5.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1210
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	8.6
	Confidence Interval	(2-Sided) 95%; -2.3 to 19.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0948
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	8.0
	Confidence Interval	(2-Sided) 95%; -1.4 to 17.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.5113
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.1
	Confidence Interval	(2-Sided) 95%; -8.2 to 16.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Secondary Outcome

Title	Change From Baseline in Lipoprotein(a)
Time Frame	Baseline, Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Week 4	-1.9 (3.97)	-3.6 (4.06)
Week 8	2.1 (3.16)	-2.6 (3.23)
Week 12	2.1 (4.00)	1.7 (4.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 4
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.7276
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -7.8 to 11.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 8
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.2218
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; -2.9 to 12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments	Week 12
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9420
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -9.2 to 9.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Secondary Outcome

Title	Percent Change From Baseline in High-sensitivity C-reactive Protein
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Least Squares Mean (Standard Error) [Percent Change]	57.33 (64.525)	24.76 (66.946)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.6786
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	32.57
	Confidence Interval	(2-Sided) 95%; -122.98 to 188.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

34. Secondary Outcome

Title	Change From Baseline in High-sensitivity C-reactive Protein
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Mean (Standard Deviation) [mg/L]	-0.40 (0.495)	0.44 (0.513)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.1648
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.84
	Confidence Interval	(2-Sided) 95%; -2.03 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	Percent Change From Baseline in Fibrinogen
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Least Squares Mean (Standard Error) [Percent Change]	61.8 (47.59)	20.3 (48.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.4701
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	41.5
	Confidence Interval	(2-Sided) 95%; -72.1 to 155.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	Change From Baseline in Fibrinogen
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Least Squares Mean (Standard Error) [mg/dL]	9.0 (13.69)	41.4 (14.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0517
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-32.4
	Confidence Interval	(2-Sided) 95%; -65.1 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

37. Secondary Outcome

Title	Percent Change From Baseline in Serum Amyloid A
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Least Squares Mean (Standard Error) [Percent Change]	34.6 (69.71)	44.1 (71.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.9111
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-9.5
	Confidence Interval	(2-Sided) 95%; -177.8 to 158.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

38. Secondary Outcome

Title	Change From Baseline in Serum Amyloid A
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	51
Least Squares Mean (Standard Error) [mg/dL]	-0.5 (2.87)	2.6 (2.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.3864
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -10.0 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

39. Secondary Outcome

Title	Percent Change From Baseline in Adiponectin
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	50
Least Squares Mean (Standard Error) [Percent Change]	17.7 (4.10)	5.4 (4.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0145
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	12.2
	Confidence Interval	(2-Sided) 95%; 2.5 to 22.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Secondary Outcome

Title	Change From Baseline in Adiponectin
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	51	50
Mean (Standard Deviation) [μg/mL]	1.2 (0.32)	0.4 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gemcabene 600 mg, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	A 2-sided test with a significance level of 0.05 was used for the comparison.
Statistical Test of Hypothesis	p-Value	0.0510
	Comments
	Method	ANCOVA
	Comments	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -0.0 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

41. Secondary Outcome

Title	Change From Baseline in Framingham Risk Score
Description	Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS Population. Missing values were imputed by LOCF.

Arm/Group Title	Gemcabene 600 mg	Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Measure Participants	53	52
Mean (Standard Deviation) [Percentage (%)]	-2.051 (4.1599)	-0.850 (4.9889)

Adverse Events

Time Frame	Baseline to end of study (Up to 113 days)
Adverse Event Reporting Description	One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
Arm/Group Title	Gemcabene 600 mg		Placebo
Arm/Group Description	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.		Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
All Cause Mortality
	Gemcabene 600 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/51 (0%)
Serious Adverse Events
	Gemcabene 600 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Gemcabene 600 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/54 (61.1%)		24/51 (47.1%)
Blood and lymphatic system disorders
Leukocytosis	1/54 (1.9%)		0/51 (0%)
Polycythaemia	1/54 (1.9%)		0/51 (0%)
Anaemia macrocytic	0/54 (0%)		1/51 (2%)
Ear and labyrinth disorders
Tinnitus	1/54 (1.9%)		0/51 (0%)
Eye disorders
Retinal cyst	1/54 (1.9%)		0/51 (0%)
Gastrointestinal disorders
Abdominal pain lower	0/54 (0%)		1/51 (2%)
Constipation	0/54 (0%)		1/51 (2%)
Diarrhoea	0/54 (0%)		1/51 (2%)
Flatulence	0/54 (0%)		1/51 (2%)
Gastric polyps	0/54 (0%)		1/51 (2%)
Gastrointestinal pain	0/54 (0%)		1/51 (2%)
Large intestine polyp	0/54 (0%)		1/51 (2%)
Toothache	0/54 (0%)		1/51 (2%)
General disorders
Fatigue	3/54 (5.6%)		1/51 (2%)
Oedema	1/54 (1.9%)		0/51 (0%)
Peripheral swelling	1/54 (1.9%)		0/51 (0%)
Non-cardiac chest pain	0/54 (0%)		1/51 (2%)
Oedema peripheral	0/54 (0%)		1/51 (2%)
Infections and infestations
Upper respiratory tract infection	8/54 (14.8%)		4/51 (7.8%)
Nasopharyngitis	5/54 (9.3%)		0/51 (0%)
Urinary tract infection	3/54 (5.6%)		1/51 (2%)
Bronchitis	1/54 (1.9%)		0/51 (0%)
Cellulitis	1/54 (1.9%)		0/51 (0%)
Gastroenteritis viral	1/54 (1.9%)		0/51 (0%)
Influenza	1/54 (1.9%)		1/51 (2%)
Sinusitis	1/54 (1.9%)		2/51 (3.9%)
Tooth abscess	1/54 (1.9%)		0/51 (0%)
Diverticulitis	0/54 (0%)		1/51 (2%)
Gastroenteritis	0/54 (0%)		1/51 (2%)
Pneumonia	0/54 (0%)		1/51 (2%)
Viral upper respiratory tract infection	0/54 (0%)		1/51 (2%)
Injury, poisoning and procedural complications
Skin abrasion	1/54 (1.9%)		0/51 (0%)
Arthropod bite	0/54 (0%)		1/51 (2%)
Contusion	0/54 (0%)		1/51 (2%)
Ligament sprain	0/54 (0%)		1/51 (2%)
Meniscus injury	0/54 (0%)		1/51 (2%)
Muscle strain	0/54 (0%)		1/51 (2%)
Investigations
Immunology test abnormal	3/54 (5.6%)		1/51 (2%)
Blood creatine phosphokinase increased	2/54 (3.7%)		0/51 (0%)
Glomerular filtration rate decreased	2/54 (3.7%)		0/51 (0%)
Haemoglobin decreased	1/54 (1.9%)		0/51 (0%)
Red blood cell count decreased	1/54 (1.9%)		0/51 (0%)
White blood cells urine positive	0/54 (0%)		1/51 (2%)
Metabolism and nutrition disorders
Decreased appetite	1/54 (1.9%)		0/51 (0%)
Increased appetite	0/54 (0%)		1/51 (2%)
Type 2 diabetes mellitus	0/54 (0%)		1/51 (2%)
Musculoskeletal and connective tissue disorders
Plantar fasciitis	2/54 (3.7%)		0/51 (0%)
Bursitis	1/54 (1.9%)		0/51 (0%)
Joint crepitation	1/54 (1.9%)		0/51 (0%)
Myalgia	1/54 (1.9%)		1/51 (2%)
Arthralgia	0/54 (0%)		2/51 (3.9%)
Arthritis	0/54 (0%)		1/51 (2%)
Back pain	0/54 (0%)		2/51 (3.9%)
Pain in extremity	0/54 (0%)		1/51 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/54 (0%)		1/51 (2%)
Nervous system disorders
Dizziness	2/54 (3.7%)		0/51 (0%)
Headache	1/54 (1.9%)		1/51 (2%)
Hypogeusia	1/54 (1.9%)		0/51 (0%)
Tension headache	1/54 (1.9%)		0/51 (0%)
Sinus headache	0/54 (0%)		1/51 (2%)
Psychiatric disorders
Panic attack	1/54 (1.9%)		0/51 (0%)
Renal and urinary disorders
Albuminuria	1/54 (1.9%)		0/51 (0%)
Proteinuria	1/54 (1.9%)		0/51 (0%)
Pollakiuria	0/54 (0%)		1/51 (2%)
Urine abnormality	0/54 (0%)		1/51 (2%)
Respiratory, thoracic and mediastinal disorders
Cough	1/54 (1.9%)		1/51 (2%)
Dyspnoea	1/54 (1.9%)		0/51 (0%)
Nasal inflammation	1/54 (1.9%)		0/51 (0%)
Oropharyngeal pain	1/54 (1.9%)		0/51 (0%)
Sinus congestion	1/54 (1.9%)		1/51 (2%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/54 (1.9%)		0/51 (0%)
Pruritus	0/54 (0%)		1/51 (2%)
Vascular disorders
Flushing	0/54 (0%)		1/51 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.