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NCT03508687 · ClinicalTrials.gov registry record · Phase 1
Study of Gemcabene in Adults With FPLD
A Phase 1 study of NASH - Nonalcoholic Steatohepatitis and Hypertriglyceridemia, sponsored by Elif Oral.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03508687 is a Phase 1 study of NASH - Nonalcoholic Steatohepatitis and Hypertriglyceridemia that has completed, run by Elif Oral. The registered enrollment target is 5 participants, below the 269-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03508687, a Phase 1 study of NASH - Nonalcoholic Steatohepatitis and Hypertriglyceridemia, has completed, sponsored by Elif Oral.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG 300mg Gemcabene
- DRUG 600mg Gemcabene
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-03-13 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03508687
The ClinicalTrials.gov registry entry for NCT03508687 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 269-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (98% lower). The listed sponsor is Elif Oral, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which 300mg Gemcabene is the first listed.
NCT03508687 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT03508687 about?
NCT03508687 is a clinical study titled "Study of Gemcabene in Adults With FPLD". 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...
What is the current status of trial NCT03508687?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-03-13. Estimated completion is 2019-07-31.
What conditions does trial NCT03508687 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis, Hypertriglyceridemia, Fatty Liver, Familial Partial Lipodystrophy.
What interventions are being tested in trial NCT03508687?
The interventions under investigation include: 300mg Gemcabene (DRUG), 600mg Gemcabene (DRUG).
Who is sponsoring clinical trial NCT03508687?
This trial is sponsored by Elif Oral, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03508687 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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