CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Gemcabenedrug
Likely dose
Gemcabene 300 mg orally once daily for 4 weeks, then 600 mg orally once daily for 4 weeks, then 900 mg orally once daily for 4 weeksAI-extracted
Key inclusion· 6
  • ✓Age ≥17 years at consent
  • ✓Confirmed or clinically diagnosed homozygous familial hypercholesterolemia (HoFH)
  • ✓Currently on stable lipid-lowering therapy (statins, PCSK9 inhibitors, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid, or combinations) for ≥4 weeks
  • ✓Fasting LDL-C >130 mg/dL (3.36 mmol/L) at screening
Key exclusion· 19
  • ✕Other forms of primary hyperlipoproteinemia or secondary causes of hypercholesterolemia
  • ✕Active liver disease (cirrhosis, alcoholic liver disease, HBV, HCV, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, or HIV
  • ✕Moderate or severe chronic hepatic impairment (Child-Pugh Grade B or C)
  • ✕Triglycerides >400 mg/dL (4.52 mmol/L) at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02722408
NCT02722408Phase 2Completed
CompareCT.gov

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 (COBALT-1)

NeuroBo Pharmaceuticals Inc.·interventional·Posted Mar 30, 2016·Updated Jun 25, 2020

In Brief

A Phase 2 clinical trial evaluating Gemcabene for Hypercholesteremia. Completed, enrolled 8 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesteremia
CountriesCanada, Israel, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartJun 1, 2016
Primary CompletionApr 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.3 years ago

Interventions

Gemcabenedrug

300 mg tablet orally once daily for four weeks followed by 600 mg tablet orally once daily for four weeks followed by 900 mg tablet orally once daily for four weeks.