A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
- Registration Number
- NCT02634151
- Lead Sponsor
- NeuroBo Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks. Gemcabene 600 mg Gemcabene Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in LDL-C at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in VLDL-C Baseline, Weeks 2, 4, 8 and 12 Change From Baseline in VLDL-C Baseline, Weeks 2, 4, 8 and 12 Percent Change From Baseline in HDL-C Baseline, Weeks 2, 4, 8 and 12 Change From Baseline in HDL-C Baseline, Weeks 2, 4, 8 and 12 Number of Participants Achieving LDL-C Reduction of ≥10% Weeks 4, 8 and 12 Number of Participants Achieving LDL-C Reduction of ≥15% Weeks 4, 8 and 12 Number of Participants Achieving LDL-C Reduction of ≥20% Weeks 4, 8 and 12 Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L) Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein B Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein B Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein A-I Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein A-I Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein A-II Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein A-II Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein C-II Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein C-II Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein C-III Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein C-III Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Apolipoprotein E Baseline, Weeks 4, 8 and 12 Change From Baseline in Apolipoprotein E Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in Lipoprotein(a) Baseline, Weeks 4, 8 and 12 Change From Baseline in Lipoprotein(a) Baseline, Weeks 4, 8 and 12 Percent Change From Baseline in High-sensitivity C-reactive Protein Baseline, Week 12 Change From Baseline in High-sensitivity C-reactive Protein Baseline, Week 12 Percent Change From Baseline in Fibrinogen Baseline, Week 12 Change From Baseline in Fibrinogen Baseline, Week 12 Percent Change From Baseline in Serum Amyloid A Baseline, Week 12 Change From Baseline in Serum Amyloid A Baseline, Week 12 Percent Change From Baseline in Adiponectin Baseline, Week 12 Change From Baseline in Adiponectin Baseline, Week 12 Change From Baseline in TC Baseline, Weeks 2, 4, 8 and 12 Percent Change From Baseline in TG Baseline, Weeks 2, 4, 8 and 12 Change From Baseline in TG Baseline, Weeks 2, 4, 8 and 12 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.
Change From Baseline in LDL-C Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12 Percent Change From Baseline in LDL-C Baseline, average of weeks 8 and 12 Percent Change From Baseline in Non-HDL-C Baseline, Weeks 2, 4, 8 and 12 Change From Baseline in Non-HDL-C Baseline, Weeks 2, 4, 8 and 12 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.
Percent Change From Baseline in TC Baseline, Weeks 2, 4, 8 and 12
Trial Locations
- Locations (21)
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Atlantic Clinical Research Collaborative- Cardiology
🇺🇸Atlantis, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Meridien Research, Inc.
🇺🇸Maitland, Florida, United States
Mid-Hudson Medical Research
🇺🇸New Windsor, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Green and Seidner Family Practice Associates
🇺🇸Lansdale, Pennsylvania, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Evanston Premier Healthcare Research, LLC
🇺🇸Evanston, Illinois, United States
Diagnostics Research Grup
🇺🇸San Antonio, Texas, United States
Central Research Associates, Inc.
🇺🇸Birmingham, Alabama, United States
National Research Institute
🇺🇸Richmond, Virginia, United States
L-MARC
🇺🇸Louisville, Kentucky, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Varkey Medical
🇺🇸Tampa, Florida, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Associates in Medicine
🇺🇸Houston, Texas, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Sentral Clinical Research Services
🇺🇸Cincinnati, Ohio, United States