Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05579977
• Collaborator: (none)
• Enrollment: 780
• Locations: 56
• Arms: 13
• Anticipated Duration (Months): 14.4
• Patients Per Site: 13.9
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.

Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Obesity	Drug: PF-07081532; Other: Placebo; Drug: Rybelsus	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 780 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM
• Actual Study Start Date: Oct 27, 2022
• Anticipated Primary Completion Date: Dec 10, 2023
• Anticipated Study Completion Date: Jan 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-07081532 20 mg T2DM PF-07081532 20 mg daily in T2DM	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 40 mg T2DM PF-07081532 40 mg daily in T2DM	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 80 mg T2DM PF-07081532 80 mg daily in T2DM	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 160 mg T2DM PF-07081532 160 mg daily in T2DM	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 260 mg T2DM PF-07081532 260 mg daily in T2DM	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Placebo Comparator: Placebo T2DM Placebo daily in T2DM	Other: Placebo; No drug
Experimental: PF-07081532 80 mg Obesity PF-07081532 80 mg daily in Obesity	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 140 mg Obesity PF-07081532 140 mg daily in Obesity	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 200 mg Obesity (Option 1) PF-07081532 200 mg daily in Obesity	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 200 mg Obesity (Option 2) PF-07081532 200 mg daily in Obesity	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Experimental: PF-07081532 260 mg Obesity PF-07081532 260 mg daily in Obesity	Drug: PF-07081532; Oral glucagon-like peptide-1 receptor agonist
Active Comparator: Rybelsus 14 mg T2DM Semaglutide 14 mg daily in T2DM	Drug: Rybelsus; Oral Semaglutide
Placebo Comparator: Placebo Obesity Placebo in Obesity	Other: Placebo; No drug

Outcome Measures

Primary Outcome Measures

1. Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM) [baseline, week 32]

2. Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity [baseline, week 32]

Secondary Outcome Measures

1. Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM [week 32]

2. Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM [baseline, week 32]

3. Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM [baseline, week 32]

4. Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM [baseline, week 32]

5. Proportion of participants achieving ≥5% body weight loss at Week 32 relative to baseline in Obesity [baseline, week 32]

6. Proportion of participants achieving ≥10% body weight loss at Week 32 relative to baseline in Obesity [Week 32]

7. Proportion of participants achieving≥15% body weight loss at Week 32 relative to baseline in Obesity [Week 32]

8. Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity [baseline, week 32]

9. Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity [baseline, week 32]

10. Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity [baseline, week 32]

11. Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity [baseline, week 32]

12. To compare PF 07081532 to placebo in the number of participants reporting Adverse Events [week 36 and 48]

13. To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events [week 36, week 48]

14. To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation [week 36, week 48]

15. To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia [Week 36, week 48]

16. To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities [Week 36, week 48]

17. To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities [Week 36, Week 48]

18. To compare PF 07081532 to placebo in the number of participants with ECG abnormalities [Week 34, week 46]

19. Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity [Week 32 and 44]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

T2DM

• T2DM inadequately controlled with metformin

• BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)

• HbA1C of 7% to 10% (53-86 mmol/mol)

• FPG ≤270 mg/dL (15 mmol/L)

Obesity

• BMI ≥30.0 kg/m2

• HbA1C ≤6.4% (47 mmol/mol)

• FPG ≤126 mg/dL (7 mmol/L)

Exclusion Criteria:

• Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)

• Use of pharmacological agents with approved indication for weight loss

• T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;

• Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS

• Clinically significant cardiovascular conditions

• Uncontrolled blood pressure

• Personal or within first-degree relative family history of MTC or MEN2

• Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

• Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Clinical Research	Centreville	Alabama	United States	35042
2	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
3	San Fernando Valley Health Institute	Canoga Park	California	United States	91304
4	Catalina Research Institute, LLC	Montclair	California	United States	91763
5	Empire Clinical Research	Pomona	California	United States	91767
6	University Clinical Investigators, Inc.	Tustin	California	United States	92780
7	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
8	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
9	Adult Medicine of Lake County	Mount Dora	Florida	United States	32757
10	Endocrine Research Solutions, Inc.	Roswell	Georgia	United States	30076
11	Cedar Crosse Research Center	Chicago	Illinois	United States	60607
12	Evanston Premier Healthcare Research LLC	Skokie	Illinois	United States	60077
13	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa	United States	50265
14	Anderson Medical Research	Fort Washington	Maryland	United States	20744
15	StudyMetrix Research	Saint Peters	Missouri	United States	63303
16	Mercury Street Medical Group, PLLC	Butte	Montana	United States	59701
17	CenExel-HRI	Berlin	New Jersey	United States	08009
18	Premier Research	Trenton	New Jersey	United States	08611
19	Medication Management	Greensboro	North Carolina	United States	27405
20	Meridian Clinical Research, LLC	Cincinnati	Ohio	United States	45219
21	Alliance for Multispecialty Research, LLC	Norman	Oklahoma	United States	73069
22	Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)	Pittsburgh	Pennsylvania	United States	15236
23	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
24	Velocity Clinical Research, Providence	East Greenwich	Rhode Island	United States	02818
25	Elligo Clinical Research Center	Austin	Texas	United States	78738
26	Velocity Clinical Research, Dallas	Dallas	Texas	United States	75230
27	Medical Colleagues of Texas, LLP	Katy	Texas	United States	77450
28	Northeast Clinical Research of San Antonio	San Antonio	Texas	United States	78233
29	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
30	Sugar Lakes Family Practice	Sugar Land	Texas	United States	77479
31	Chrysalis Clinical Research	Saint George	Utah	United States	84790
32	Southwest Internal Medicine	Saint George	Utah	United States	84790
33	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
34	Dr. M.B. Jones Inc.	Victoria	British Columbia	Canada	V8V 4A1
35	G A Research Associates	Moncton	New Brunswick	Canada	E1G 1A7
36	Aggarwal and Associates Limited	Brampton	Ontario	Canada	L6T 0G1
37	Dawson Clinical Research	Guelph	Ontario	Canada	N1H 1B1
38	Milestone Research Inc.	London	Ontario	Canada	N5W 6A2
39	Bluewater Clinical Research Group Inc.	Sarnia	Ontario	Canada	N7T 4X3
40	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario	Canada	M4G 3E8
41	Manna Research Mirabel	Mirabel	Quebec	Canada	J7J 2K8
42	Diex Recherche Victoriavile Inc.	Victoriaville	Quebec	Canada	G6P 6P6
43	Diex Recherche Quebec Inc.	Quebec		Canada	G1V 4T3
44	Centre de Recherche Saint-Louis	Quebec		Canada	G1W 4R4
45	Nakakinen clinic	Naka	Ibaraki	Japan	311-0113
46	Yokohama Minoru Clinic	Yokohama	Kanagawa	Japan	232-0064
47	Shiraiwa Medical Clinic	Kashiwara	Osaka	Japan	582-0005
48	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka	Japan	565-0853
49	Seiwa Clinic	Adachi-ku	Tokyo	Japan	120-0011
50	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo	Japan	103-0027
51	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo	Japan	103-0028
52	Fukuwa Clinic	Chuo-ku	Tokyo	Japan	104-0031
53	Medical Corporation Heishinkai ToCROM Clinic	Shinjuku-ku	Tokyo	Japan	160-0008
54	Yokohama Minoru Clinic	Yokohama		Japan	232-0064
55	Latin Clinical Trial Center	San Juan		Puerto Rico	00909
56	GCM Medical Group, PSC - Hato Rey Site	San Juan		Puerto Rico	00917

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05579977
• Other Study ID Numbers: C3991004; 2022-002834-15
• First Posted: Oct 14, 2022
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Diabetes Mellitus; Obesity
• Additional relevant MeSH terms: Diabetes Mellitus; Obesity

Study Results

No Results Posted as of Jan 19, 2023