Trial Outcomes & Findings for The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease (NCT NCT05364684)

Last Updated: 2026-01-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

6 Months

Results posted on

2026-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. LUM-201: LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.
Overall Study STARTED	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Treatment n=12 Participants 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. LUM-201: LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.
Age, Continuous	44 years STANDARD_DEVIATION 13 • n=37 Participants
Sex: Female, Male Female	5 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	3 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants
Race (NIH/OMB) White	7 Participants n=37 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Baseline Liver Fat (Percent liver fat by 1H-MRS)	18.5 percent liver fat STANDARD_DEVIATION 10.8 • n=37 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Open-label Treatment With Ibutamoren n=7 Participants Open-label study of oral LUM-201 (ibutamoren mesylate) 25 mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and NAFLD.
Intrahepatic Lipid Content (IHL, Percent Liver Fat)	3.9 absolute change in percentage liver fat Standard Deviation 6.7

SECONDARY outcome

Timeframe: 6 Months

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).

Outcome measures

Outcome measures
Measure	Open-label Treatment With Ibutamoren n=7 Participants Open-label study of oral LUM-201 (ibutamoren mesylate) 25 mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and NAFLD.
Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score	39 ms Standard Deviation 44

SECONDARY outcome

Timeframe: 6 Months

Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L).

Outcome measures

Outcome measures
Measure	Open-label Treatment With Ibutamoren n=7 Participants Open-label study of oral LUM-201 (ibutamoren mesylate) 25 mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and NAFLD.
Alanine Aminotransferase (ALT)	8 U/L Standard Deviation 18

Adverse Events

Open-label Treatment

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label Treatment n=12 participants at risk 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. LUM-201: LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.
Eye disorders Blurry vision	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Gastroenteritis	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Diarrhea	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Increased gas/bloating	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Epigastric pain/GERD	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Constipation	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Fatigue	25.0% 3/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Night sweats	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Gastrointestinal disorders Abdominal pain	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Ear and labyrinth disorders Ear infection	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Increased appetite	58.3% 7/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Increased thirst/urination	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Infections and infestations Upper respiratory infection	33.3% 4/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Brain fog	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Endocrine disorders Hyperglycemia	33.3% 4/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Headaches	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Swelling of extremity	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Musculoskeletal and connective tissue disorders Joint pain	25.0% 3/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Metabolism and nutrition disorders Weight gain (>5%)	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Insomnia	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Nocturia	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Soreness at site of vaccine	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Reproductive system and breast disorders Vulvodynia	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Chest tightness/anxiety	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Congestion/cough	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
General disorders Hypertension	16.7% 2/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Renal and urinary disorders Groin/flank pain with kidney stone	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Infections and infestations HPV+ on PAP	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.
Musculoskeletal and connective tissue disorders Muscle pain	8.3% 1/12 • 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. Adverse events are defined as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with drug exposure, whether or not considered related to drug exposure. Adverse events were assessed through regular investigator assessment at all study visits and at other points of patient contact between visits.

Additional Information

Dr. Laura E. Dichtel

Massachusetts General Hospital

Phone: 6177263870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place