Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name NAFLD

NCTNCT02217345Other id2014P001680

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 131 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 2 Jun 2017
Primary completion: 10 Aug 2021
Completion: 13 Sept 2021
First posted: 15 Aug 2014 (estimated)
Last update posted: 22 Nov 2022
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019202020212022

Ph 2
NAFLD
NCT02217345
2 Jun 2017 to 13 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Growth hormoneDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Time frame · 6 months
Registry description
Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

Secondary outcomes(1)

Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.
Time frame · 6 months
Registry description
Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

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.

Group	Value (percent liver fat)	Spread
Growth Hormone	-5.2	10.5
Placebo	3.8	6.9

Secondary and other outcome results(1)

Secondary outcomeMean· 6 months

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

Group	Value (mg/L)	Spread
Growth Hormone	-0.8	0.9
Placebo	0.3	1.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Growth HormoneGrowth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	0 / 24	1 / 24	15 / 24
PlaceboPlacebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.	0 / 25	0 / 25	11 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Ages 18 - 65 yr 2. 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. Exclusion Criteria: 1. Serum creatinine \> 2 times the upper limit of normal 2. History of cancer, except for non-melanoma skin cancers 3. Active carpel tunnel syndrome 4. 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. 5. Contraindications to magnetic resonance imaging (MRI). 6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception. 7. Breastfeeding 8. Aspartate and aminotransferase levels \>10x upper limit of normal

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