At a glance
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An Investigator-Initiated Open-Label, Randomized Study of Gemcabene in Adults With Familial Partial Lipodystrophy Disease (FPLD)
In Brief
A Phase 2 clinical trial evaluating 300mg Gemcabene and 600mg Gemcabene for Familial Partial Lipodystrophy and 3 related conditions. Completed, enrolled 5 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
300mg Gemcabene
600mg Gemcabene