The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

NCT05364684 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2022P001057
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

NAFLD; Nonalcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score

  6 Months

• Alanine Aminotransferase (ALT)

  6 Months

Study Arms (1)

Open-label Treatment

OTHER

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

Interventions

LUM-201 DRUG

LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.

Also known as: Ibutamoren Mesylate

Open-label Treatment

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

ibutamoren mesylate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Laura E. Dichtel
• Organization: Massachusetts General Hospital

ldichtel@mgh.harvard.edu

6177263870

Study Officials

• Laura E. Dichtel, MD, MHS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label study with historical controls.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: August 10, 2022
• Primary Completion: November 22, 2024
• Study Completion: December 23, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

US (1)