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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Primary Purpose

NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LUM-201
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Intrahepatic lipid content (IHL, %)
Change in intrahepatic lipid content (IHL, %) as measured by proton magnetic resonance spectroscopy (1H-MRS).

Secondary Outcome Measures

Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score
Change in hepatic inflammation and fibrosis by LiverMultiScan cT1. Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms)
Alanine aminotransferase (ALT)
Change in ALT

Full Information

First Posted
May 3, 2022
Last Updated
September 26, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05364684
Brief Title
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Official Title
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label study with historical controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LUM-201
Other Intervention Name(s)
Ibutamoren Mesylate
Intervention Description
LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.
Primary Outcome Measure Information:
Title
Intrahepatic lipid content (IHL, %)
Description
Change in intrahepatic lipid content (IHL, %) as measured by proton magnetic resonance spectroscopy (1H-MRS).
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score
Description
Change in hepatic inflammation and fibrosis by LiverMultiScan cT1. Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms)
Time Frame
6 Months
Title
Alanine aminotransferase (ALT)
Description
Change in ALT
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura E. Dichtel, MD, MHS
Phone
617-726-3870
Email
ldichtel@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura E. Dichtel, MD, MHS
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura E Dichtel, MD
Phone
617-724-3870
Email
ldichtel@partners.org

12. IPD Sharing Statement

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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

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