Clinical Trial: Efficacy and Safety of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid-Lowering Therapy (COBALT-1)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Open-Label, Dose-Finding Study to Assess the Efficacy, Safety, and Tolerability of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid Lowering Therapy (COBA
Brief Summary: The purpose of this study is to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.
Detailed Summary:
Sponsor: Gemphire Therapeutics, Inc.
Current Primary Outcome: LDL-C [ Time Frame: Baseline and 28, 56, and 84 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- non-HDL-C [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Total Cholesterol [TC] [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Triglycerides [TG] [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- HDL-C [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Very low-density lipoprotein [VLDL-C] [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- hsCRP [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Fibrinogen [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Lipoprotein(a) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein B (ApoB) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein A-1 (ApoA-1) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein A-II (ApoA-II) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein C-II (ApoC-II) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein C-III (ApoC-III) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Apolipoprotein E(ApoE) [ Time Frame: Baseline and 28, 56, and 84 days ]Percent change from baseline
- Adverse Events [ Time Frame: 84 days ]
- Clinical Laboratory [ Time Frame: 84 days ]
Original Secondary Outcome: Same as current
Information By: Gemphire Therapeutics, Inc.
Dates:
Date Received: March 12, 2016
Date Started: May 2016
Date Completion: February 2017
Last Updated: October 27, 2016
Last Verified: October 2016