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Gemcabene for the Treatment of Pediatric NAFLD

NCT03436420 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-12-31

Study results available
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Summary

This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcabene once a day for 12 weeks will reduce alanine aminotransferase (ALT), hepatic steatosis, dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Gemcabene

Participants will take 300 milligrams (mg) of gemcabene, once per day for 12 weeks.

Sponsors & Collaborators

  • Gemphire Therapeutics

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Miriam B Vos, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2019-08-27
Completion
2019-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03436420 on ClinicalTrials.gov