NCT02634151
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Hypercholesteremia
- Sponsor
- NeuroBo Pharmaceuticals Inc.
- Enrollment
- 105
- Locations
- 21
- Primary Endpoint
- Percent Change From Baseline in LDL-C at Week 12
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
Intervention: Placebo
Gemcabene 600 mg
Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
Intervention: Gemcabene
Outcomes
Primary Outcomes
Percent Change From Baseline in LDL-C at Week 12
Time Frame: Baseline, Week 12
Secondary Outcomes
- 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)
- 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)
- Change From Baseline in Apolipoprotein A-I(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)
- 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)
- Percent Change From Baseline in TC(Baseline, Weeks 2, 4, 8 and 12)
Study Sites (21)
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