Status:
COMPLETED
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Non-Alcoholic Fatty Liver Disease
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth ho...
Eligibility Criteria
Inclusion
- Men and women 18-65yo
- Body mass index (BMI) ≥ 30kg/m2, or, for participants with known steatohepatitis, BMI ≥ 25kg/m2
- Hepatic steatosis as demonstrated by either a) Grade 1+ steatosis on a liver biopsy performed within 12 months of the baseline visit, without \>10% reduction in body weight or addition of medications to treat fatty liver, or b) liver fat fraction ≥5% on hydrogen-magnetic resonance spectroscopy (1H-MRS)
- Hepatitis C antibody and Hepatitis B surface antigen negative. Subjects without known history of Hepatitis C or Hepatitis C treatment who have a positive Hepatitis C antibody but a negative hepatitis C viral load will also be eligible.
- For females ≥50yo, negative mammogram within 1 year of baseline
- If use of vitamin E ≥400 international units daily, stable dose for ≥6 mos
- Up to date with colon cancer screening recommended by the participant's primary care physician, using whatever methodology the primary physician recommends. This will be ascertained by self-report. (If a participant does not have a primary care physician, we will discuss that colon cancer screening is recommended, typically starting at age 50y, and refer the participant to primary care through Partners if s/he desires.)
Exclusion
- Heavy alcohol use defined as consumption of \> 20 grams daily for women or \> 30 grans daily for men for at least 3 consecutive months over the past 5 years assessed using the Lifetime Drinking History Questionnaire
- Known diagnosis of diabetes, use of any anti-diabetic medications (including thiazolidinediones or metformin), fasting glucose \>126mg/dL, or hemoglobin A1c (HbA1c) ≥6.5%. Participants with stable use of metformin ≥6 months will be permitted if it is being used for pre-diabetes or another non-diabetes indication (e.g., PCOS).
- Use of any specific pharmacological treatments for NAFLD/nonalcoholic steatohepatitis except vitamin E
- Known cirrhosis, Child-Pugh score ≥7, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam. If a subject is not known to be cirrhotic at screen but is found to be cirrhotic based on the results of liver biopsy at baseline, this subject will be referred to a hepatologist for clinical care and will be excluded from further participation in the study.
- Chronic systemic corticosteroid use in the ≤6 months prior to the baseline visit
- Chronic use of Actigall, methotrexate, amiodarone, or tamoxifen
- Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
- Use of growth hormone or growth hormone releasing hormone within the past 6 months
- Change in lipid lowering or anti-hypertensive regimen within 2 months of screening
- Hemoglobin \< 10.0 g/dL or Creatinine \>1.5mg/dL
- Active malignancy
- For men, history of prostate cancer or evidence of prostate malignancy by prostate specific antigen (PSA) \> 5 ng/mL
- Severe chronic illness judged by the investigator to present a contraindication to participation
- History of hypopituitarism, head irradiation or any other condition known to affect the GH axis
- Use of physiologic testosterone (men) or estrogen or progesterone (women) unless stable use for a year or more prior to study entry
- Routine magnetic resonance imaging (MRI) exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
- Weight loss surgery within 1 year before baseline. Weight loss surgery more than 1 year prior to baseline visit is permissible as long as no active weight loss (\<10% decrease in weight over past 6 months)
- For women, positive urine pregnancy test (hCG), trying to achieve pregnancy, or breastfeeding
- For women able to become pregnant, unwillingness to use an acceptable form of birth control during the study.
- Known hypersensitivity to tesamorelin or mannitol
- Contraindication to receiving beta-blocker or nitroglycerin (which are part of the coronary angiography)
- Significant radiation exposure, including any history of radiation therapy, or any of the following in the 12 months prior to randomization: a) more than 2 percutaneous coronary interventions; b) more than 2 myocardial perfusion studies; 3) more than 2 computed tomography angiograms
- Active consideration for a procedure or treatment that involves significant radiation exposure as defined above in the 12 months following randomization
- Not willing or able to adhere to dose schedules and required procedures per protocol
- Judged by the investigator to be inappropriate for the study for other reasons not detailed above.
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03375788
Start Date
January 17 2019
End Date
January 10 2025
Last Update
November 20 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114