A Phase 2 interventional study of Cholic Acid in Hepatic Steatosis, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
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.
Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to develop insulin resistance and its associated metabolic complications such as dyslipidemia, diabetes mellitus and hepatic steatosis. Nonalcoholic hepatic steatosis or steatohepatitis caused by excessive accumulation of triglycerides in hepatocytes, in fact, is a common feature of these disorders. Often a cause for significant morbidity and even mortality in lipodystrophic patients, hepatic steatosis poses a significant therapeutic challenge. Recent insight into the role of primary bile acids, cholic acid and chenodeoxycholic acid, which are endogenous ligands for the farnesoid X receptor (FXR), in regulating hepatic triglyceride homeostasis offers new treatment options for hepatic steatosis. Cholic acid was shown to inhibit hepatic triglyceride accumulation by more than 50% in a mouse model of hepatic steatosis and hypertriglyceridemia. Cholic acid has been previously used to treat inborn errors of bile acid synthesis in children without any side effects. In other studies in adults, cholic acid has been reported to be well tolerated. Therefore, we propose to investigate a potentially safe therapeutic option for its efficacy in reducing hepatic steatosis in patients with lipodystrophies.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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The human immunodeficiency virus, which weakens the immune system.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cholic Acid weight based dose for 6 months double-blind
Drug: Cholic Acid
Placebo for Cholic Acid for 6 months double-blind
Drug: Cholic Acid
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.
Hepatic Triglyceride (%)
Measured by proton magnetic resonance spectroscopy (MRS)
Time frame: 6 months
Serum Triglycerides
Time frame: Months 6
Recruitment December 2006 through April 2010. A total of 37 subjects were screened for this trial.
| Milestone | Cholic Acid Then Placebo | Placebo Then Cholic Acid |
|---|---|---|
| Started | 9 | 9 |
| Completed | 6 | 7 |
| Not completed | 3 | 2 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Unrelated illness | 0 | 2 |
| Milestone | Cholic Acid Then Placebo | Placebo Then Cholic Acid |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Unrelated illness ineligible for mrs | 0 | 1 |
Measured by proton magnetic resonance spectroscopy (MRS)
| Fat/Fat+Water (%) | Cholic Acid | Placebo |
|---|---|---|
| Hepatic Triglyceride (%) | 15.9 (10.5 to 26.5) | 14.8 (9.4 to 19) |
| mg/dL | Cholic Acid | Placebo |
|---|---|---|
| Serum Triglycerides | 390 (233 to 595) | 340 (233 to 433) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cholic Acid | 0/14 (0%) | 0/14 (0%) | 5/14 (35.7%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| Event | Cholic Acid | Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 5/14 | 0/15 |
| Flu Like SymptomsRespiratory, thoracic and mediastinal disorders | 0/14 | 2/15 |
| GastroenteritisGastrointestinal disorders | 0/14 | 1/15 |
| Heart FailureCardiac disorders | 0/14 | 1/15 |
Baseline data is for all the patients enrolled
| Age, Continuous(years) | Characteristics of All Patients Enrolled |
|---|---|
| Mean | 46 ± 15.3 |
| Sex: Female, Male(Participants) | Characteristics of All Patients Enrolled |
|---|---|
| Female | 7 |
| Male | 11 |
| Hepatic TG (%)(Fat/Fat+Water (%)) | Characteristics of All Patients Enrolled |
|---|---|
| Median | 23.89 (6.1 to 60.3) |
| Serum Triglyceride(mg/dL) | Characteristics of All Patients Enrolled |
|---|---|
| Median | 389 (155 to 3455) |
The record gives a start of Apr 2006, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 7 years 9 months after primary completion.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholic Acid
University of Texas Southwestern Medical Center →