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Growth Hormone Secretagogue

Ibutamoren for Nonalcoholic Fatty Liver Disease

Q: Is there an open call for volunteers to join this research endeavor?

Affirmative. Per the information posted on clinicaltrials.gov, this research is currently sourcing candidates; it was initially published on August 10th 2022 and its most recent update occurred September 26th 2022. The study needs 12 participants to be enrolled at a single site.

Q: How many participants are being evaluated in this medical experiment?

Affirmative, clinicaltrials.gov data confirms the recruitment status of this trial which went live on August 10th 2022 and was recently modified on September 26th 2022. The study requires a total of 12 patients to be recruited from 1 location.

Q: Do individuals aged eighty and above qualify for this trial?

This study mandates that potential participants have to be aged between 21 and 60, in order to qualify.

Q: Is my involvement permissible in this research endeavor?

This clinical trial is seeking 12 guinea pigs with nonalcoholic fatty liver between 21 and 60 years of age. The inclusion criteria necessitates that participants must have a BMI greater than 25 kg/m2, histological or radiological evidence of NAFLD / <a href="https://www.withpower.com/clinical-trials/nash">NASH</a>, as well as an insulin-like growth factor-1 (IGF-1) level below the 3rd quartile for their respective age group.

Q: Has this therapy achieved official sanction from the FDA?

There is a decent body of evidence on the safety profile of this medical intervention, so it earned a rating of 2. However, Phase 2 trials do not necessarily provide data to support its efficacy.

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intrahepatic lipid content (IHL, %)

Secondary outcome measures

Alanine aminotransferase (ALT)

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,629 Total Patients Enrolled

14 Trials studying Non-alcoholic Fatty Liver Disease

835 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Laura E. Dichtel, MD, MHSPrincipal InvestigatorMassachusetts General Hospital

Media Library

Ibutamoren (Growth Hormone Secretagogue) Clinical Trial Eligibility Overview. Trial Name: NCT05364684 — Phase 2

Non-alcoholic Fatty Liver Disease Research Study Groups: Open-label Treatment

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Ibutamoren Highlights & Side Effects. Trial Name: NCT05364684 — Phase 2

Ibutamoren (Growth Hormone Secretagogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364684 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open call for volunteers to join this research endeavor?

"Affirmative. Per the information posted on clinicaltrials.gov, this research is currently sourcing candidates; it was initially published on August 10th 2022 and its most recent update occurred September 26th 2022. The study needs 12 participants to be enrolled at a single site."

Answered by AI

How many participants are being evaluated in this medical experiment?

"Affirmative, clinicaltrials.gov data confirms the recruitment status of this trial which went live on August 10th 2022 and was recently modified on September 26th 2022. The study requires a total of 12 patients to be recruited from 1 location."

Answered by AI

Do individuals aged eighty and above qualify for this trial?

"This study mandates that potential participants have to be aged between 21 and 60, in order to qualify."

Answered by AI

Is my involvement permissible in this research endeavor?

"This clinical trial is seeking 12 guinea pigs with nonalcoholic fatty liver between 21 and 60 years of age. The inclusion criteria necessitates that participants must have a BMI greater than 25 kg/m2, histological or radiological evidence of NAFLD / NASH, as well as an insulin-like growth factor-1 (IGF-1) level below the 3rd quartile for their respective age group."

Answered by AI

Has this therapy achieved official sanction from the FDA?

"There is a decent body of evidence on the safety profile of this medical intervention, so it earned a rating of 2. However, Phase 2 trials do not necessarily provide data to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Laura Dichtel, MD 2022. "The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05364684.

All > Nonalcoholic Fatty Liver Disease