CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
LUM-201drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05364684
NCT05364684Phase 2Completed
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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study

Massachusetts General Hospital·interventional·Posted May 6, 2022·Updated Jan 6, 2026

In Brief

A Phase 2 clinical trial evaluating LUM-201 for NAFLD and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMay 6, 2022
Enrollment StartAug 10, 2022
Primary CompletionNov 22, 2024
Study CompletionDec 23, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.2 years ago

Interventions

LUM-201drug

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