Early Phase 1
N=24
Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
NAFLD
Bottom Line
View on ClinicalTrials.gov: NCT02726542 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Apr 2021
Primary outcome: Primary: Change in Hepatic Fat Fraction — -3.0; 0.3 Percent (Hepatic fat fraction, percent)
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- somatropin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hepatic Fat Fraction |
-3.0; 0.3 | — |
| SECONDARY Change in Aspartate Aminotransferase (AST) |
-3; -1 | — |
| SECONDARY Change in Alanine Aminotransferase (ALT) |
-2; 1 | — |
| SECONDARY Change in Gamma Glutamyl Transferase (GGT) |
-9; 5 | — |
| SECONDARY Change in Visceral Adipose Tissue |
-6; 6 | — |
Summary
Fatty liver disease is an increasing problem in overweight and obese young adults. The purpose of this study is to test the effect of growth hormone on liver fat in obese young adults ages 18-29y with increased liver fat.
Eligibility Criteria
Inclusion criteria
- Males and Females ages 18-29yo
- BMI ≥95th percentile and/or ≥30kg/m^2
- Hepatic fat ≥5% by hydrogen magnetic resonance spectroscopy (1H-MRS)
- IGF-1 standard deviation score (SDS) 14 drinks per week (Females) or >21 drinks per week (Males)
- Use of insulin or oral anti-diabetic medications, or hemoglobin A1c (HbA1c) >7% or fasting glucose ≥126mg/dL
- Use of corticosteroid, gonadal steroids, or methotrexate ≤ 3 months prior to baseline visit
- Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
- hemoglobin 2.5x upper limit of normal (ULN), total bilirubin > ULN, positive hepatitis B surface antigen (sAg), or positive hepatitis C antibody
- Routine magnetic resonance imaging (MRI) exclusion criteria (including weight >450 pounds)
- Use of weight-loss medications or previous weight loss surgery
- Pregnant or breastfeeding, or, for sexually-active females, unwillingness to use an appropriate form of contraception during the study
- Known cirrhosis or clinical evidence of cirrhosis or portal hypertension on imaging or exam
- Use of growth hormone (GH) or growth hormone releasing hormone within the past 1 year
- Change in lipid lowering or anti-hypertensive medications within 3 months of screening
- Change in vitamin E or ursodiol <6 months before screen; subjects on stable doses of Vitamin E and/or Ursodiol for ≥6 months will be eligible.
- History of malignancy or active malignancy
- History of hypopituitarism, head irradiation or any other condition or chronic illness known to affect the GH axis
Data sourced from ClinicalTrials.gov (NCT02726542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.