Phase 2
Completed N=50
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Source: ClinicalTrials.gov NCT01066364 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI — 17.9; 14.2 % of fat
Summary
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI |
17.9; 14.2 | — |
| SECONDARY Insulin Sensitivity as Determined by HOMA-IR |
8.3; 7.6 | — |
| SECONDARY Serum ALT and AST Values |
79.1; 86.6; 49.9; 56.2 | — |
| SECONDARY Lipid Profiles |
115.8; 124.0; 202.4; 200.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age at entry at least 18 years.
- Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
- Evidence of hepatic steatosis or liver fat (>5%) by MRI.
- Evidence of definite or suspected NASH
- Written informed consent.
Exclusion criteria
- Evidence of another form of liver disease.
- History of excess alcohol ingestion.
- Contraindications to liver biopsy.
- Decompensated liver disease.
- History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
- Recent initiation or change of anti-diabetic drugs.
- Use of colesevelam or other agents in the same class.
- Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
- Positive test for anti-HIV.
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
- Pregnancy or inability to practice adequate contraception in women of childbearing potential.
- Evidence of hepatocellular carcinoma
Data sourced from ClinicalTrials.gov (NCT01066364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.