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NCT05364684 · ClinicalTrials.gov registry record · Phase 2
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT05364684: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT05364684 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05364684, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG LUM-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 2 |
What the finished NCT05364684 record still lists
NCT05364684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which LUM-201 is the first listed.
NCT05364684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05364684 about?
NCT05364684 is a clinical study titled "The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease". 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 o...
What is the current status of trial NCT05364684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-08-10. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT05364684?
The interventions under investigation include: LUM-201 (DRUG).
Who is sponsoring clinical trial NCT05364684?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05364684's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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