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Growth Hormone Releasing Hormone Analog

Tesamorelin for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women aged 18-65 years old
Be older than 18 years old
Must not have
Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
Chronic use of Actigall, methotrexate, amiodarone, or tamoxifen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 months
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is investigating whether a drug called tesamorelin, which helps the body produce growth hormone, can reduce the amount of fat in the liver and improve liver inflammation in people with obesity and nonalcoholic fatty liver disease.

Who is the study for?
This trial is for men and women aged 18-65 with obesity-related fatty liver disease (NAFLD), without cirrhosis, significant alcohol use, or diabetes. Participants must have a BMI ≥30kg/m2 (or ≥25kg/m2 if they have steatohepatitis), confirmed liver fat issues but not on certain medications like growth hormones or systemic corticosteroids recently.
What is being tested?
The study tests whether tesamorelin, a drug that stimulates the release of growth hormone, can reduce liver fat and inflammation in obese individuals with NAFLD. It's compared to a placebo in this randomized trial to see if it improves cardiovascular risks associated with fatty liver disease.
What are the potential side effects?
Tesamorelin may cause reactions at the injection site, joint pain, swelling in hands or feet, muscle discomfort, and possible increases in blood sugar levels. As it affects hormone levels, patients might experience other hormonal changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a specific liver condition.
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I regularly use Actigall, methotrexate, amiodarone, or tamoxifen.
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I currently have cancer.
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I am considering a treatment that involves significant radiation in the next year.
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I am unable to follow the treatment plan as required.
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I am a man with prostate cancer or my PSA level is above 5 ng/mL.
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I have a condition that affects my growth hormone levels.
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I am not pregnant, trying to get pregnant, or breastfeeding.
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I cannot take beta-blockers or nitroglycerin due to health reasons.
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I have not had significant radiation exposure or multiple specific heart or imaging tests in the last year.
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I have severe liver disease or cirrhosis.
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I have not used any specific drugs for fatty liver disease except vitamin E.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Liver Fat Content
Secondary study objectives
Fibrosis Score
NAFLD Activity Score
Post-prandial hepatic de novo lipogenesis

Side effects data

From 2008 Phase 3 trial • 263 Patients • NCT00608023
9%
Upper respiratory tract infection
3%
Diarrhoea
3%
Injection site erythema
2%
Paresthesia
1%
Musculosketal stiffness
1%
Chest pain
1%
Retinopathy
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tesamorelin 52 Weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Placebo (26 Weeks) - Tesamorelin (26 Weeks)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TesamorelinExperimental Treatment1 Intervention
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
identical placebo given subcutaneously daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,235 Total Patients Enrolled

Media Library

Tesamorelin (Growth Hormone Releasing Hormone Analog) Clinical Trial Eligibility Overview. Trial Name: NCT03375788 — Phase 2
Fatty Liver Disease Research Study Groups: Tesamorelin, Placebo
Fatty Liver Disease Clinical Trial 2023: Tesamorelin Highlights & Side Effects. Trial Name: NCT03375788 — Phase 2
Tesamorelin (Growth Hormone Releasing Hormone Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03375788 — Phase 2
~11 spots leftby Nov 2025
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