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Completed

NCT Number: NCT05364684

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 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).

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

LUM-201

Drug

LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.

Other names: Ibutamoren Mesylate

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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).

  2. Alanine Aminotransferase (ALT)

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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