← Back to Search

Growth Hormone Secretagogue

Ibutamoren for Nonalcoholic Fatty Liver Disease

Phase 2

Waitlist Available

Led By Laura E. Dichtel, MD, MHS

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiographic or histologic diagnosis of NAFLD / NASH

Insulin-like growth factor-1 (IGF-1) level <3rd quartile of normal for age

Must not have

Known pituitary or hypothalamic disease affecting the growth hormone axis

Cirrhosis or known liver disease other than NAFLD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can reduce the amount of fat in the liver for people who are obese and have nonalcoholic fatty liver disease.

Who is the study for?

This trial is for adults aged 21-60 with a BMI of at least 25 who have been diagnosed with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), and have lower than normal levels of IGF-1. It's not open to those with diabetes, other liver diseases, pituitary or hypothalamic disorders, recent use of certain drugs that affect the liver, interactions with LUM-201, history of cancer or significant heart/kidney disease, or if pregnant/breastfeeding.

What is being tested?

The trial tests whether Ibutamoren mesylate (LUM-201) can reduce fat in the liver among people without alcohol-related liver issues. The study will measure changes in intrahepatic lipid content using advanced imaging techniques like proton magnetic resonance spectroscopy.

What are the potential side effects?

While specific side effects for LUM-201 are not listed here, similar medications may cause increased appetite leading to weight gain, muscle pain or stiffness, and potential changes in blood sugar levels which need monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with fatty liver disease or NASH.

Select...

My IGF-1 levels are in the lower 75% for my age group.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition affecting my pituitary or hypothalamus that impacts growth hormone.

Select...

I have liver disease, but it's not NAFLD.

Select...

I have diabetes or take medication for it.

Select...

I haven't taken drugs like steroids, methotrexate, or tamoxifen in the last year.

Select...

I have a history of cancer, kidney disease, or serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intrahepatic lipid content (IHL, %)

Secondary study objectives

Alanine aminotransferase (ALT)

Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label TreatmentExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUM-201

2020

Completed Phase 2

~90

0 / 7Eligibility criteria met