NAFLDPhase 2NCT05364684

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

A Phase 2 study testing LUM-201 in people with NAFLD and Nonalcoholic Fatty Liver, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for: NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
What is being tested?: LUM-201
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2022to 23 Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Contraindications to MRI imaging
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
Pregnancy or breastfeeding
Known pituitary or hypothalamic disease affecting the growth hormone axis
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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study

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).

Conditions: NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
Being tested: LUM-201
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LUM-201Drug
Also called Ibutamoren Mesylate
LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.

Study groups in NCT05364684
Study group	Role	What they receive
Open-label Treatment	Other	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. Receives: Drug: LUM-201

What is being measured

The primary outcome is the main question the study is designed to answer.

Intrahepatic Lipid Content (IHL, Percent Liver Fat)
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.
Measured: 6 Months

Secondary outcomes (2)

Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score
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).
Measured: 6 Months
Alanine Aminotransferase (ALT)
Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L).
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202223 Dec 2024

First posted6 May 2022
Study start10 Aug 2022
Primary completion22 Nov 2024
Study completion23 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NAFLDStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open-label study with historical controls.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05364684
Sponsor's protocol ID: 2022P001057
Status last verified: Dec 2025
First submitted: 3 May 2022
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

All NAFLD trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study
ClinicalTrials.gov ID: NCT05364684
Acronym / sponsor ID: 2022P001057
Conditions: NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 10 Aug 2022 (actual)
Primary completion: 22 Nov 2024 (actual)
Study completion: 23 Dec 2024 (actual)
First posted: 6 May 2022 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label study with historical controls.

Arm	Type	Receives
Open-label Treatment	Other	Drug: LUM-201Open-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.

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

Contraindications to MRI imaging
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
Pregnancy or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LUM-201Also: Ibutamoren MesylateLUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.	Drug	Open-label Treatment

Primary outcome

Intrahepatic Lipid Content (IHL, Percent Liver Fat)
Time frame: 6 Months
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.

2 secondary outcomes

Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score
Time frame: 6 Months
Alanine Aminotransferase (ALT)
Time frame: 6 Months

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label Treatment	12	7

Primary outcome: Intrahepatic Lipid Content (IHL, Percent Liver Fat)

Time frame: 6 Months. Mean (Standard Deviation). Unit: absolute change in percentage liver fat

Measure	Open-label Treatment With Ibutamoren n = 7
Value	3.9 (6.7)

Open-label Treatment With Ibutamoren: p = 0.4, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were followed for each patient starting at the time of the screening period (minimum 0.5 months, maximum 3 months), during the six-month treatment phase (6 months), and for one month after the subject's last study visit. This represents a total time frame for adverse event assessment of approximately 7.5 months to 10 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label Treatment	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for NAFLD

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura E. Dichtel, MD, MHS principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LUM-201 in people with NAFLD and Nonalcoholic Fatty Liver, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrahepatic Lipid Content (IHL, Percent Liver Fat) (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.