The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver
• Intervention / Treatment: Drug: LUM-201

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open-label Treatment; 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.	Drug: LUM-201; LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.; Other Names: Ibutamoren Mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrahepatic Lipid Content (IHL, Percent Liver Fat)	Change in intrahepatic lipid content (6-month percent liver fat minus baseline percent liver fat) as measured by proton magnetic resonance spectroscopy (1H-MRS). Outcome is presented as change in percent liver fat.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score	Change in hepatic inflammation and fibrosis by LiverMultiScan cT1 (6-month cT1 score minus baseline cT1 score). Outcome is presented as change in cT1 score (ms). Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms).	6 Months
Alanine Aminotransferase (ALT)	Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L).	6 Months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Laura E. Dichtel, MD, MHS, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; ibutamoren mesylate
• Other Study ID Numbers: 2022P001057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No