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A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia

NCT02944383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-06-25

Study results available
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Summary

A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)

Conditions

Interventions

DRUG

Gemcabene

Gemcabene tablets administered orally once daily, for 12 weeks.

DRUG

Placebo

Placebo tablets administered orally once daily, for 12 weeks.

Sponsors & Collaborators

  • NeuroBo Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Lee Golden, MD · NeuroBo Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-01-11
Completion
2018-05-09

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944383 on ClinicalTrials.gov