Back to resultsEfficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemcabene
Gemcabene
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL-C, Lipid Regulator
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Gemcabene 300 mg QD
Gemcabene 900 mg QD
Arm Description
Placebo treatment on stable background statin therapy
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Outcomes
Primary Outcome Measures
LDL-C - percent change from baseline at Week 8
Secondary Outcome Measures
Plasma lipid levels - percent change from baseline at Week 8
apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Adverse Events
Clinical Laboratory
Full Information
NCT ID
NCT02571257
First Posted
October 5, 2015
Last Updated
April 8, 2020
Sponsor
NeuroBo Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02571257
Brief Title
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroBo Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
LDL-C, Lipid Regulator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment on stable background statin therapy
Arm Title
Gemcabene 300 mg QD
Arm Type
Experimental
Arm Description
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Arm Title
Gemcabene 900 mg QD
Arm Type
Experimental
Arm Description
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Intervention Type
Drug
Intervention Name(s)
Gemcabene
Intervention Description
1-300 mg tablet, QD, 56 days
Intervention Type
Drug
Intervention Name(s)
Gemcabene
Intervention Description
3-300 mg tablets, QD, 56 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LDL-C - percent change from baseline at Week 8
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Plasma lipid levels - percent change from baseline at Week 8
Description
apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Time Frame
56 days
Title
Adverse Events
Time Frame
56 days
Title
Clinical Laboratory
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
27678439
Citation
Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.
Results Reference
derived
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Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
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