At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Cholic Aciddrug
Likely dose
Cholic Acid 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy Patients
University of Texas Southwestern Medical Center·interventional·Posted Apr 6, 2007·Updated Aug 6, 2025
In Brief
A Phase 2 clinical trial evaluating Cholic Acid for Hepatic Steatosis. Completed, enrolled 18 participants across 1 site.
Detailed Summary
To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Steatosis
CountriesUnited States
CollaboratorsFDA Office of Orphan Products Development
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedApr 2007
Primary CompletionApr 2011
TodayJul 2026
First PostedApr 6, 2007
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 19.2 years ago
Interventions
Cholic Aciddrug
Capsules of active Cholic Acid or matching placebo, total dose is 15 mg/kg per day, maximum dose of 1500 mg per day, taken PO, BID.