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NCT02217345: NAFLD

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

Completed Phase 2 Results posted Last updated 22 November 2022
What this trial tests

Phase 2 trial testing Growth hormone in Nonalcoholic Fatty Liver Disease (NAFLD) in 131 participants. Completed in 13 September 2021.

Timeline
2 June 2017
Primary endpoint
10 August 2021
13 September 2021

Quick facts

Lead sponsorMassachusetts General Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment131
Start date2 June 2017
Primary completion10 August 2021
Estimated completion13 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 65, any sex, with Nonalcoholic Fatty Liver Disease (NAFLD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 6 months

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

GroupValue95% CI
Growth Hormone-5.2± 10.5
Placebo3.8± 6.9
Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months. Secondary · 6 months

Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

GroupValue95% CI
Growth Hormone-0.8± 0.9
Placebo0.3± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Growth Hormone
Serious: 1/24 (4%)
Deaths: 0/24
Placebo
Serious: 0/25 (0%)
Deaths: 0/25

Serious adverse events (1 terms)

ReactionSystemGrowth HormonePlacebo
Unrelated surgical procedureSurgical and medical procedures
Other adverse events (8 terms — click to expand)

ReactionSystemGrowth HormonePlacebo
Joint Pain or StiffnessMusculoskeletal and connective tissue disorders
EdemaBlood and lymphatic system disorders
Injection site discomfort or bruisingSkin and subcutaneous tissue disorders
HeadacheGeneral disorders
MyalgiaMusculoskeletal and connective tissue disorders
Numbness or tinglingNervous system disorders
Carpal Tunnel SyndromeMusculoskeletal and connective tissue disorders
Allergic ReactionImmune system disorders

Most-reported serious reactions: Unrelated surgical procedure.

Data from ClinicalTrials.gov NCT02217345 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hepatic lipid metabolism and non-alcoholic fatty liver disease in aging.
    Gong Z, Tas E, Yakar S, Muzumdar R. · · 2017 · cited 105× · PMID 28017785 · DOI 10.1016/j.mce.2016.12.022
  2. Growth Hormone Inhibits Hepatic De Novo Lipogenesis in Adult Mice.
    Cordoba-Chacon J, Majumdar N, List EO, Diaz-Ruiz A, et al · · 2015 · cited 91× · PMID 26015548 · DOI 10.2337/db15-0370
  3. Growth Hormone Control of Hepatic Lipid Metabolism.
    Liu Z, Cordoba-Chacon J, Kineman RD, Cronstein BN, et al · · 2016 · cited 73× · PMID 27679560 · DOI 10.2337/db16-0649
  4. Growth Hormone and Insulin-Like Growth Factor 1 Regulation of Nonalcoholic Fatty Liver Disease.
    Dichtel LE, Cordoba-Chacon J, Kineman RD. · · 2022 · cited 63× · PMID 35172328 · DOI 10.1210/clinem/dgac088
  5. The GH/IGF-1 Axis Is Associated With Intrahepatic Lipid Content and Hepatocellular Damage in Overweight/Obesity.
    Dichtel LE, Corey KE, Haines MS, Chicote ML, et al · · 2022 · cited 28× · PMID 35779256 · DOI 10.1210/clinem/dgac405
  6. Nonalcoholic Fatty Liver Disease and Endocrine Axes-A Scoping Review.
    Von-Hafe M, Borges-Canha M, Vale C, Leite AR, et al · · 2022 · cited 28× · PMID 35448486 · DOI 10.3390/metabo12040298
  7. Increased ATP synthesis might counteract hepatic lipid accumulation in acromegaly.
    Fellinger P, Wolf P, Pfleger L, Krumpolec P, et al · · 2020 · cited 24× · PMID 32106111 · DOI 10.1172/jci.insight.134638
  8. Growth Hormone Administration Improves Nonalcoholic Fatty Liver Disease in Overweight/Obesity: A Randomized Trial.
    Dichtel LE, Corey KE, Haines MS, Chicote ML, et al · · 2023 · cited 22× · PMID 37379033 · DOI 10.1210/clinem/dgad375

Verify or expand the search:

Other trials of Growth hormone

Trials testing the same drug.

Other recruiting trials for Nonalcoholic Fatty Liver Disease (NAFLD)

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02217345.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing