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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Plain-language guide to NCT05364684: phase 2 interventional trial of MK-677 (Ibutamoren), fatty liver & elevated liver enzymes, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05364684
- Phase
- phase 2
- Status
- completed
- Start
- 2022-08-10
- Completion (planned or actual)
- 2024-11-22
- Participants
- 12 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- NAFLD; Nonalcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around MK-677 (Ibutamoren) for fatty liver & elevated liver enzymes.
A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure.
It had 1 arm (groups): Open-label Treatment (other).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 12 actual participants took part.
It was open to people of any sex aged from 21 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 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.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: contraindications to mri imaging; diabetes mellitus or use of diabetes medications; cirrhosis or known liver disease other than nafld.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when MK-677 (Ibutamoren) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-08-10 with completion listed for 2024-11-22.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Intrahepatic Lipid Content (IHL, Percent Liver Fat) (time frame: 6 Months).
It also tracked 2 secondary outcomes, for example Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score and Alanine Aminotransferase (ALT).
What This Means in Plain Language
Put simply, this is a phase 2 trial of MK-677 (Ibutamoren) in 12 people with fatty liver & elevated liver enzymes.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the MK-677 (Ibutamoren) compound page, Fatty liver & elevated liver enzymes research.
Our Notes on the Compound
MK-677 (Ibutamoren): An oral, non-peptide ghrelin-receptor agonist.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.