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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tesamorelin, a drug that may reduce liver fat and inflammation in individuals with non-alcoholic fatty liver disease (NAFLD). NAFLD commonly affects those with obesity and can lead to serious liver issues. The trial compares tesamorelin to a placebo to determine its effectiveness in improving liver health. Suitable participants have obesity and confirmed liver fat buildup but do not have diabetes or heavy alcohol use. As a Phase 2 trial, this research measures tesamorelin's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain medications like anti-diabetic drugs (unless it's stable metformin for non-diabetes reasons), specific treatments for fatty liver, or growth hormone-related drugs. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that tesamorelin is likely to be safe for humans?

Research has shown that tesamorelin, a drug that helps release growth hormone, has been studied for its impact on liver fat. Earlier studies found that tesamorelin significantly reduced liver fat in people, suggesting it might help those with nonalcoholic fatty liver disease (NAFLD).

Regarding safety, the FDA has approved tesamorelin for other uses, such as reducing belly fat in HIV patients with lipodystrophy, indicating it is generally safe. However, like all medications, it can have side effects. Common ones include joint pain, redness at the injection site, and swelling in the arms or legs.

This trial is in an early stage and mainly focuses on safety and drug tolerance. Researchers are closely monitoring how participants handle the drug and any side effects. Participants should feel reassured that tesamorelin has been studied before and is considered safe for other conditions, but they should also discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for non-alcoholic fatty liver disease, which often focus on lifestyle changes and managing associated conditions like diabetes and high cholesterol, Tesamorelin offers a new approach. Tesamorelin is unique because it is a synthetic peptide that stimulates the release of growth hormone, potentially reducing liver fat by targeting metabolic pathways directly. Researchers are excited about Tesamorelin because it might provide a more direct and effective way to tackle liver fat accumulation, offering hope for patients who struggle with current management strategies.

What evidence suggests that tesamorelin might be an effective treatment for NAFLD?

This trial will compare tesamorelin with a placebo for treating nonalcoholic fatty liver disease (NAFLD). Studies have shown that tesamorelin can help reduce liver fat in people with NAFLD. In one study, patients who took tesamorelin had significantly less liver fat compared to those who took a placebo, with a reduction of about 4.1%. This suggests that tesamorelin not only lowers liver fat but may also prevent liver scarring from worsening. Research also suggests that tesamorelin could improve liver health by reducing inflammation, which is crucial for people with NAFLD. These findings indicate that tesamorelin could be a promising treatment for improving liver health in individuals with this condition. ^{1 3 4 5 6}

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

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

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

I have been diagnosed with a specific liver condition.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6981288/

Effects of Tesamorelin on Nonalcoholic Fatty Liver Disease in ... Our data demonstrate that tesamorelin reduces liver fat content in PLWH with NAFLD and further suggest it prevents a high rate of progression of fibrosis ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31611038/

Effects of tesamorelin on non-alcoholic fatty liver disease in HIV Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p ...

3. vulcanchem.com vulcanchem.com/news/tesamorelin-potential-treatment-for-non-alcoholic-fatty-liver-disease

a Potential Treatment for Non-Alcoholic Fatty Liver Disease Investigators conducted a genetic analysis that has identified tesamorelin may work to improve the adverse effects of non-alcoholic fatty liver disease.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02196831

Tesamorelin Effects on Liver Fat and Histology in HIV The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD.

5. natap.org natap.org/2019/HIV/102519_02.htm

Tesamorelin, liver fat, and NAFLD in the setting of HIV Our data show that tesamorelin reduces liver fat content in people with HIV and NAFLD and further suggest it prevents a high rate of progression ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf

EGRIFTA® (tesamorelin for injection), for subcutaneous use Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA are expected to be similar to those observed with the 2 mg dose (1 mg/ ...