NCT05364684CompletedPhase 2
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 3 May 2022
- Start date
- 10 Aug 2022
- Primary completion date
- 22 Nov 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05364684
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From 10 Aug 2022 to the primary completion date, 22 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
- Known pituitary or hypothalamic disease affecting the growth hormone axis
Other
- Contraindications to MRI imaging
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 21 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.