Trial · NCT00457639

Cholic Acid for Hepatic Steatosis in Lipodystrophy

NCT00457639, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2019-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cholic Acid for Hepatic Steatosis in Lipodystrophy. Trials, record NCT00457639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457639

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cholic Acid for Hepatic Steatosis in Lipodystrophy
NCT number: NCT00457639
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Hepatic Steatosis
Interventions: Cholic Acid
First posted: 2007-04-06
Last updated: 2025-08-06
Results first posted: 2019-01-15

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hepatic Triglyceride (%)	6 months	Measured by proton magnetic resonance spectroscopy (MRS)
Secondary	Serum Triglycerides	Months 6

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hepatic Triglyceride (%)	6 months		Fat/Fat+Water (%)	MEDIAN
SECONDARY	Serum Triglycerides	Months 6		mg/dL	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Hepatic Triglyceride (%)	Cholic Acid	15.9	Inter-Quartile Range 10.5 to 26.5	Fat/Fat+Water (%)
Hepatic Triglyceride (%)	Placebo	14.8	Inter-Quartile Range 9.4 to 19	Fat/Fat+Water (%)
Serum Triglycerides	Cholic Acid	390	Inter-Quartile Range 233 to 595	mg/dL
Serum Triglycerides	Placebo	340	Inter-Quartile Range 233 to 433	mg/dL

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Intervention 1 (6 Months)	STARTED	Cholic Acid Then Placebo	9
Intervention 1 (6 Months)	STARTED	Placebo Then Cholic Acid	9
Intervention 1 (6 Months)	COMPLETED	Cholic Acid Then Placebo	6
Intervention 1 (6 Months)	COMPLETED	Placebo Then Cholic Acid	7
Intervention 1 (6 Months)	NOT COMPLETED	Cholic Acid Then Placebo	3
Intervention 1 (6 Months)	NOT COMPLETED	Placebo Then Cholic Acid	2
Intervention 2 (6 Months)	STARTED	Cholic Acid Then Placebo	6
Intervention 2 (6 Months)	STARTED	Placebo Then Cholic Acid	7
Intervention 2 (6 Months)	COMPLETED	Cholic Acid Then Placebo	6
Intervention 2 (6 Months)	COMPLETED	Placebo Then Cholic Acid	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Gastroenteritis	Gastrointestinal disorders	Cholic Acid	0	14	0
other	Gastroenteritis	Gastrointestinal disorders	Placebo	1	15	1
other	Flu Like Symptoms	Respiratory, thoracic and mediastinal disorders	Cholic Acid	0	14	0
other	Flu Like Symptoms	Respiratory, thoracic and mediastinal disorders	Placebo	2	15	2
other	Heart Failure	Cardiac disorders	Cholic Acid	0	14	0
other	Heart Failure	Cardiac disorders	Placebo	1	15	4
other	Diarrhea	Gastrointestinal disorders	Cholic Acid	5	14	5
other	Diarrhea	Gastrointestinal disorders	Placebo	0	15	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cholic Acid	0	14
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Cholic Acid	5	14
Total, other adverse events	Placebo	4	15
Total, serious adverse events	Cholic Acid	0	14
Total, serious adverse events	Placebo	0	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23447519	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cholic Acid vs Placebo: deaths from any cause	Trial comparisons
Cholic Acid vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00457639

GET https://conductscience.org/api/trials/v1/NCT00457639/registered

API reference For AI assistants