Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

• Sponsor: NeuroBo Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02571257
• Collaborator: (none)
• Enrollment: 66
• Arms: 3
• Duration (Months): 20

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
• Study Start Date: Aug 1, 2000
• Actual Primary Completion Date: Apr 1, 2002
• Actual Study Completion Date: Apr 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo treatment on stable background statin therapy	Drug: Placebo
Experimental: Gemcabene 300 mg QD Gemcabene (also known as CI-1027) treatment on stable background statin therapy	Drug: Gemcabene; 1-300 mg tablet, QD, 56 days
Experimental: Gemcabene 900 mg QD Gemcabene (also known as CI-1027) treatment on stable background statin therapy	Drug: Gemcabene; 3-300 mg tablets, QD, 56 days

Outcome Measures

Primary Outcome Measures

1. LDL-C - percent change from baseline at Week 8 [56 days]

Secondary Outcome Measures

1. Plasma lipid levels - percent change from baseline at Week 8 [56 days]

   apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)

2. Adverse Events [56 days]

3. Clinical Laboratory [56 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and Females

• 18 to 65 years of age

• Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

• If female, postmenopausal or surgically menopausal

• Triglycerides (TG) >400 mg/dL

• Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)

• Body Mass Index (BMI) >35 kg/m2

• Uncontrolled diabetes mellitus (HbA1c >10%)

• Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)

• Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)

• Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NeuroBo Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NeuroBo Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT02571257
• Other Study ID Numbers: 1027-018
• First Posted: Oct 8, 2015
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

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

Study Results

No Results Posted as of Apr 9, 2020