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 ]

Percent change from baseline


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