The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Phase 2

Completed

• Conditions: NAFLD; Nonalcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: LUM-201

• Registration Number: NCT05364684
• Lead Sponsor: Massachusetts General Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2022-08-10
• Primary Completion: 2024-11-22
• Study Completion: 2024-12-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Age 21-60yo and generally healthy
2. BMI ≥ 25 kg/m2
3. Radiographic or histologic diagnosis of NAFLD / NASH
4. Insulin-like growth factor-1 (IGF-1) level <3rd quartile of normal for age

Exclusion Criteria

1. Contraindications to MRI imaging
2. Diabetes mellitus or use of diabetes medications
3. History of cancer, significant renal disease, decompensated or unstable cardiovascular disease
4. Cirrhosis or known liver disease other than NAFLD
5. Pregnancy or breastfeeding
6. Known pituitary or hypothalamic disease affecting the growth hormone axis
7. Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen)
8. Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label Treatment	LUM-201	Open-label study of oral LUM-201 (ibutamoren mesylate) 25mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and histologic or radiologic diagnosis of NAFLD.

Primary Outcome Measures

Name	Time	Method
Intrahepatic lipid content (IHL, %)	6 Months	Change in intrahepatic lipid content (IHL, %) as measured by proton magnetic resonance spectroscopy (1H-MRS).

Secondary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT)	6 Months	Change in ALT
Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score	6 Months	Change in hepatic inflammation and fibrosis by LiverMultiScan cT1. Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States