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
About this trial
This is an interventional treatment trial for NAFLD
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)
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
NCT ID
NCT05364684
First Posted
May 3, 2022
Last Updated
September 26, 2022
Sponsor
Massachusetts General Hospital
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
Learn more about this trial
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
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