The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364684
• Other study ID #: 2022P001057
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Laura E. Dichtel, MD, MHS
• Phone: 617-726-3870
• Email: ldichtel[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahepatic lipid content (IHL, %)	Change in intrahepatic lipid content (IHL, %) as measured by proton magnetic resonance spectroscopy (1H-MRS).	6 Months
Secondary	Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score	Change in hepatic inflammation and fibrosis by LiverMultiScan cT1. Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms)	6 Months
Secondary	Alanine aminotransferase (ALT)	Change in ALT	6 Months