Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

NCT02217345 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2014P001680
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.

  Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

  6 months

Secondary Outcomes (1)

• Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.

  6 months

Study Arms (2)

Growth hormone

EXPERIMENTAL

Growth hormone (somatropin) administered by daily injection at starting dose of 0.3 mg daily for women and 0.2 mg daily for men, with dose titration for goal IGF-1 in the upper quartile of normal for age.

Drug: Growth hormone

Placebo

PLACEBO COMPARATOR

Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding.

Drug: Placebo

Interventions

Growth hormone DRUG

growth hormone, Genotropin (Pfizer)

Also known as: Genotropin (Pfizer Inc.)

Growth hormone

Placebo DRUG

placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 - 65 yr
• NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of significant alcohol consumption and other causes of hepatic steatosis. If liver imaging or biopsy has not been performed clinically, liver ultrasound will be performed as part of the screening visit.

You may not qualify if:

• Serum creatinine \> 2 times the upper limit of normal
• History of cancer, except for non-melanoma skin cancers
• Active carpel tunnel syndrome
• Diabetes mellitus, defined as a hemoglobin A1C \>6.5 or use of any medications prescribed to treat hyperglycemia. The exception is that the use of metformin is acceptable in patients whose HbA1c has been =\<6.0 on two visits and whose weight has remained stable for six months.
• Contraindications to magnetic resonance imaging (MRI).
• Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.
• Breastfeeding
• Aspartate and aminotransferase levels \>10x upper limit of normal

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

We cannot extrapolate efficacy and safety to patients with diabetes mellitus.

Results Point of Contact

• Title: Dr. Karen K. Miller
• Organization: Massachusetts General Hospital

kkmiller@mgh.harvard.edu

617-726-3870

Study Officials

• Karen K Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuroendocrine Unit Chief

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: August 15, 2014
• Study Start: June 2, 2017
• Primary Completion: August 10, 2021
• Study Completion: September 13, 2021
• Last Updated: November 22, 2022
• Results First Posted: November 22, 2022

Record last verified: 2022-10

Locations

US (1)