Status:
COMPLETED
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
NAFLD
Nonalcoholic Fatty Liver
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
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% o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05364684
Start Date
August 10 2022
End Date
December 23 2024
Last Update
January 6 2026
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114