Trial Outcomes & Findings for Cholic Acid for Hepatic Steatosis in Lipodystrophy (NCT NCT00457639)

NCT ID: NCT00457639

Last Updated: 2025-08-06

Results Overview

Measured by proton magnetic resonance spectroscopy (MRS)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-08-06

Participant Flow

Recruitment December 2006 through April 2010. A total of 37 subjects were screened for this trial.

Participant milestones

Measure	Cholic Acid Then Placebo Cholic Acid for 6 months and then Placebo for six months in a double-blind, randomized fashion	Placebo Then Cholic Acid Placebo for 6 months and then Cholic Acid for 6 months in a double-blind, randomized fashion
Intervention 1 (6 Months) STARTED	9	9
Intervention 1 (6 Months) COMPLETED	6	7
Intervention 1 (6 Months) NOT COMPLETED	3	2
Intervention 2 (6 Months) STARTED	6	7
Intervention 2 (6 Months) COMPLETED	6	6
Intervention 2 (6 Months) NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Cholic Acid Then Placebo Cholic Acid for 6 months and then Placebo for six months in a double-blind, randomized fashion	Placebo Then Cholic Acid Placebo for 6 months and then Cholic Acid for 6 months in a double-blind, randomized fashion
Intervention 1 (6 Months) Lost to Follow-up	3	0
Intervention 1 (6 Months) unrelated illness	0	2
Intervention 2 (6 Months) Unrelated illness ineligible for MRS	0	1

Baseline Characteristics

Cholic Acid for Hepatic Steatosis in Lipodystrophy

Baseline characteristics by cohort

Measure	Characteristics of All Patients Enrolled n=18 Participants Participants who were randomized to receive either Cholic acid or Placebo
Age, Continuous	46 years STANDARD_DEVIATION 15.3 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Hepatic TG (%)	23.89 Fat/Fat+Water (%) n=93 Participants
Serum Triglyceride	389 mg/dL n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Measured by proton magnetic resonance spectroscopy (MRS)

Outcome measures

Measure	Cholic Acid n=13 Participants Cholic Acid 6 months .	Placebo n=15 Participants Placebo for 6 months.
Hepatic Triglyceride (%)	15.9 Fat/Fat+Water (%) Interval 10.5 to 26.5	14.8 Fat/Fat+Water (%) Interval 9.4 to 19.0

SECONDARY outcome

Timeframe: Months 6

Outcome measures

Measure	Cholic Acid n=13 Participants Cholic Acid 6 months .	Placebo n=15 Participants Placebo for 6 months.
Serum Triglycerides	390 mg/dL Interval 233.0 to 595.0	340 mg/dL Interval 233.0 to 433.0

Adverse Events

Cholic Acid

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cholic Acid n=14 participants at risk Cholic Acid for 6 months	Placebo n=15 participants at risk Placebo for 6 months
Gastrointestinal disorders Gastroenteritis	0.00% 0/14 • 1 year Diarrhea: Increased frequency of passing stool	6.7% 1/15 • Number of events 1 • 1 year Diarrhea: Increased frequency of passing stool
Respiratory, thoracic and mediastinal disorders Flu Like Symptoms	0.00% 0/14 • 1 year Diarrhea: Increased frequency of passing stool	13.3% 2/15 • Number of events 2 • 1 year Diarrhea: Increased frequency of passing stool
Cardiac disorders Heart Failure	0.00% 0/14 • 1 year Diarrhea: Increased frequency of passing stool	6.7% 1/15 • Number of events 4 • 1 year Diarrhea: Increased frequency of passing stool
Gastrointestinal disorders Diarrhea	35.7% 5/14 • Number of events 5 • 1 year Diarrhea: Increased frequency of passing stool	0.00% 0/15 • 1 year Diarrhea: Increased frequency of passing stool

Additional Information

Zahid Ahmad, M.D.

UT Southwestern Medical Center

Phone: 214-648-2377

Email: zahid.ahmad@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place