Phase 2
Completed N=12
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver Disease · Nonalcoholic Fatty Liver · NASH - Nonalcoholic Steatohepatitis
Source: ClinicalTrials.gov NCT05364684 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Intrahepatic Lipid Content (IHL, Percent Liver Fat) — 3.9 absolute change in percentage liver fat — p=0.4
Summary
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. The investigators hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation as quantified by proton magnetic resonance spectroscopy (1H-MRS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intrahepatic Lipid Content (IHL, Percent Liver Fat) |
3.9 | 0.4 |
| SECONDARY Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score |
39 | 0.9 |
| SECONDARY Alanine Aminotransferase (ALT) |
8 | 0.6 |
Eligibility Criteria
Inclusion Criteria
- Age 21-60yo and generally healthy
- BMI ≥ 25 kg/m2
- Radiographic or histologic diagnosis of NAFLD / NASH
- Insulin-like growth factor-1 (IGF-1) level <3rd quartile of normal for age
Exclusion Criteria
- Contraindications to MRI imaging
- Diabetes mellitus or use of diabetes medications
- History of cancer, significant renal disease, decompensated or unstable cardiovascular disease
- Cirrhosis or known liver disease other than NAFLD
- Pregnancy or breastfeeding
- Known pituitary or hypothalamic disease affecting the growth hormone axis
- Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen)
- Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)
Data sourced from ClinicalTrials.gov (NCT05364684). 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.