Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

NCTNCT05364684Other id2022P001057

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 12 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 10 Aug 2022
Primary completion: 22 Nov 2024
Completion: 23 Dec 2024
First posted: 6 May 2022
Last update posted: 6 Jan 2026
Conditions: NAFLD · Nonalcoholic Fatty Liver · NASH - Nonalcoholic Steatohepatitis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 2
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684
10 Aug 2022 to 23 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

LUM-201Drug

Arms1

Other
Open-label Treatment
Open-label study of oral LUM-201 (ibutamoren mesylate) 25mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and histologic or radiologic diagnosis of NAFLD.

Primary outcomes1

Outcomes the sponsor listed as primary.

Intrahepatic Lipid Content (IHL, Percent Liver Fat)
Time frame · 6 Months
Registry description
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.

Secondary outcomes(2)

Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score
Time frame · 6 Months
Registry description
Change in hepatic inflammation and fibrosis by LiverMultiScan cT1 (6-month cT1 score minus baseline cT1 score). Outcome is presented as change in cT1 score (ms). Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms).
Alanine Aminotransferase (ALT)
Time frame · 6 Months
Registry description
Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 Months

Intrahepatic Lipid Content (IHL, Percent Liver Fat)

Group	Value (absolute change in percentage liver fat)	Spread
Open-label Treatment With Ibutamoren	3.9	6.7

Secondary and other outcome results(2)

Secondary outcomeMean· 6 Months

Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score

Group	Value (ms)	Spread
Open-label Treatment With Ibutamoren	39	44

Secondary outcomeMean· 6 Months

Alanine Aminotransferase (ALT)

Group	Value (U/L)	Spread
Open-label Treatment With Ibutamoren	8	18

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Open-label TreatmentOpen-label study of oral LUM-201 (ibutamoren mesylate) 25mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and histologic or radiologic diagnosis of NAFLD. LUM-201: LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.	0 / 12	0 / 12	12 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age 21-60yo and generally healthy 2. BMI ≥ 25 kg/m2 3. Radiographic or histologic diagnosis of NAFLD / NASH 4. Insulin-like growth factor-1 (IGF-1) level \<3rd quartile of normal for age Exclusion Criteria: 1. Contraindications to MRI imaging 2. Diabetes mellitus or use of diabetes medications 3. History of cancer, significant renal disease, decompensated or unstable cardiovascular disease 4. Cirrhosis or known liver disease other than NAFLD 5. Pregnancy or breastfeeding 6. Known pituitary or hypothalamic disease affecting the growth hormone axis 7. Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen) 8. Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)

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