CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Growth hormone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02217345
NCT02217345Phase 2Completed

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

Massachusetts General Hospital·interventional·Posted Aug 15, 2014·Updated Nov 22, 2022

In Brief

A Phase 2 clinical trial evaluating Growth hormone and Placebo for Nonalcoholic Fatty Liver Disease (NAFLD). Completed, enrolled 131 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 15, 2014
Enrollment StartJun 2, 2017
Primary CompletionAug 10, 2021
Study CompletionSep 13, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.9 years ago

Interventions

Growth hormonedrug

growth hormone, Genotropin (Pfizer)

Placebodrug

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