Phase 2 N=12 Treatment

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

NAFLD · Nonalcoholic Fatty Liver · NASH - Nonalcoholic Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT05364684 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Intrahepatic Lipid Content (IHL, Percent Liver Fat) — 3.9 absolute change in percentage liver fat — p=0.4

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LUM-201 (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Nov 2024

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

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).

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)

View full record on ClinicalTrials.gov →

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.