Tesamorelin for Non-alcoholic Fatty Liver Disease

Overseen By Takara L Stanley, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-diabetics, Corticosteroids, Growth hormones, others

Disqualifiers: Diabetes, Cirrhosis, Active malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflammation in the liver, both of which would be helpful to individuals with NAFLD. The purpose of this study is to investigate whether treatment with a drug called tesamorelin, which is a growth hormone releasing hormone analogue, will decrease liver fat and improve liver inflammation and scarring in obese individuals with NAFLD.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body mass index (BMI) ≥ 30kg/m2, or for participants with known steatohepatitis, BMI ≥ 25kg/m2

I am a woman over 50 and had a negative mammogram in the last year.

I have been taking vitamin E (≥400 IU daily) for at least 6 months.

Exclusion Criteria

I have diabetes or high blood sugar, or I'm taking medication for it.

I have been diagnosed with a specific liver condition.

Severe chronic illness judged by the investigator to present a contraindication to participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tesamorelin or placebo daily for 12 months to assess its effect on liver fat and inflammation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tesamorelin

Trial Overview 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.

How Is the Trial Designed?

Group I: Tesamorelin Experimental Treatment 1 Intervention

tesamorelin (brand name Egrifta) 2mg daily given subcutaneously

Group II: Placebo Placebo Group 1 Intervention

identical placebo given subcutaneously daily

Tesamorelin is already approved in United States for the following indications:

Approved in United States as Egrifta for:

• Lipodystrophy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+