CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Gemcabene +1 moredrug
Likely dose
Gemcabene 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02634151
NCT02634151Phase 2Completed
CompareCT.gov

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

NeuroBo Pharmaceuticals Inc.·interventional·Posted Dec 17, 2015·Updated Jun 25, 2020

In Brief

A Phase 2 clinical trial evaluating Gemcabene and Placebo for Hypercholesteremia. Completed, enrolled 105 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesteremia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 17, 2015
Enrollment StartNov 1, 2016
Primary CompletionJun 1, 2017
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.5 years ago

Interventions

Gemcabenedrug

Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.

Placebodrug

Three placebo tablets administered orally once daily for 12 weeks.