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Study of Gemcabene in Adults With FPLD

NCT03508687 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-08-17

Study results available
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Summary

The overall objective of this study is to assess the efficacy and safety of two dosing regimens of gemcabene (300 mg once daily for 24 weeks or 300 mg daily for 12 weeks followed by 600 mg daily for 12 weeks) in up to eight patients with Familial Partial Lipodystrophy with high triglycerides and Non-Alcoholic Fatty Liver Disease. The study will consist of a six week Wash Out Period, up to a 28 day Screening Period, a 24 week Treatment Period, and a follow-on safety assessment four weeks post final dose. Study participation will last approximately 4 months and includes at least 9 study visits, and can be as many as 11 study visits.

Conditions

  • Familial Partial Lipodystrophy
  • Hypertriglyceridemia
  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

300mg Gemcabene

300mg Gemcabene

DRUG

600mg Gemcabene

600mg Gemcabene

Sponsors & Collaborators

  • Elif Oral

    lead OTHER

Principal Investigators

  • Elif A Oral, M.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-13
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03508687 on ClinicalTrials.gov