The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2024-12-23

Brief Summary

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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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Detailed Description

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Conditions

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NAFLD Nonalcoholic Fatty Liver NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label study with historical controls.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

LUM-201

Intervention Type DRUG

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

Interventions

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LUM-201

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

Intervention Type DRUG

Other Intervention Names

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Ibutamoren Mesylate

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes