NAFLDEarly Phase 1NCT02726542
Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
A Early Phase 1 study testing somatropin in people with NAFLD, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- NAFLD
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 2 Apr 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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) < 0
Who cannot join
- Alcohol consumption of >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 < 11.0 g/dL or weight < 50kg
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN), total bilirubin > ULN, positive hepatitis B surface antigen (sAg), or positive hepatitis C antibody
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.
- Conditions
- NAFLD
- Being tested
- somatropin
- Keywords
- obesity, adolescence, fatty liver, growth hormone
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Norditropin (growth hormone) given by injection using a pen-device
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone | Experimental | Somatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels. Receives: Drug: somatropin |
| No treatment | No intervention | (no study treatment - observation only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatic Fat Fraction
change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy
Measured: 24 weeks
Secondary outcomes (4)
Change in Aspartate Aminotransferase (AST)
change in AST between baseline and 24 weeks
Measured: 24 weeks
Change in Alanine Aminotransferase (ALT)
change in ALT between baseline and 24 weeks
Measured: 24 weeks
Change in Gamma Glutamyl Transferase (GGT)
change in GGT between baseline and 24 weeks
Measured: 24 weeks
Change in Visceral Adipose Tissue
Change in visceral adipose tissue cross-sectional area at the 4th lumbar vertebra as measured by magnetic resonance imaging between baseline and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start3 May 2017
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takara Stanley, Massachusetts General Hospital
- Investigators
- Takara Stanley, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726542
- Sponsor's protocol ID
- 2016p-000657
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2016
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents
- ClinicalTrials.gov ID
- NCT02726542
- Acronym / sponsor ID
- 2016p-000657
- Conditions
- NAFLD
- Keywords
- obesity, adolescence, fatty liver, growth hormone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a significant health problem in obese adolescents. Obese children and adolescents have significant reductions in growth hormone secretion, and we hypothesize that augmenting growth hormone in this population will decrease liver fat. Growth hormone inhibits hepatic de novo lipogenesis, which is an important source of hepatic lipid. Patients with pituitary GH deficiency have a higher prevalence of NAFLD and non-alcoholic steatohepatitis (NASH) than the general population, and replacement of GH in these individuals reduces signs of liver damage. The purpose of this study is to test the hypothesis that growth hormone treatment will decrease liver fat quantity in young adults who begin the trial with more than 5% liver fat measured by magnetic resonance spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone | Experimental | Drug: somatropinSomatropin given by daily subcutaneous injection. Dose will begin at 1mg and be titrated based on insulin-like growth factor 1 (IGF-1) levels. |
| No treatment | No intervention | –(no study treatment - observation only) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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) < 0
Key exclusion criteria (15 listed)
- Alcohol consumption of >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 < 11.0 g/dL or weight < 50kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropinNorditropin (growth hormone) given by injection using a pen-device | Drug | Growth hormone |
Primary outcome
Change in Hepatic Fat Fraction
Time frame: 24 weeks
change in hepatic fat fraction between baseline and 24 weeks as measured by hydrogen magnetic resonance spectroscopy
4 secondary outcomes
Change in Aspartate Aminotransferase (AST)
Time frame: 24 weeks
Change in Alanine Aminotransferase (ALT)
Time frame: 24 weeks
Change in Gamma Glutamyl Transferase (GGT)
Time frame: 24 weeks
Change in Visceral Adipose Tissue
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for NAFLD
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takara Stanley, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing somatropin in people with NAFLD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatic Fat Fraction (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.