Resmetirom for Fatty Liver Disease and HIV

Not yet recruiting at 8 trial locations

Overseen By Holly Crandall, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Naga P. Chalasani

Must be taking: Antiretroviral therapy

Disqualifiers: Significant alcohol use, Other liver diseases, Cirrhosis, Uncontrolled T2DM, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of resmetirom for individuals with both MASLD (a type of fatty liver disease) and HIV. Although resmetirom is already available on the market, it has not been tested in this specific group. The study will compare resmetirom to a placebo (a pill with no active drug) to determine if it can reduce liver fat. Suitable candidates for this trial are adults with HIV who are on stable antiretroviral therapy and have been diagnosed with MASLD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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

The trial does not specify if you need to stop taking your current medications, but it does require that your HIV treatment (antiretroviral therapy) remains stable for at least 3 months before and during the study.

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

Research has shown that resmetirom is generally safe and well-tolerated. In one study, 86.5% of patients taking a 100 mg dose reported some side effects after starting the drug. Similar results appeared with both 100 mg and 80 mg doses, suggesting that while many may experience side effects, they are usually manageable.

Resmetirom is already used for other liver conditions, indicating thorough safety testing in humans. However, this study examines its use in individuals with both MASLD (a type of liver disease) and HIV, which is a new combination. The goal is to determine if resmetirom can effectively reduce liver fat in this group.

This phase of the study indicates that the treatment has already passed initial safety checks. Researchers are now confirming its safety and effectiveness specifically for people with MASLD and HIV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for fatty liver disease?

Resmetirom is unique because it targets thyroid hormone receptors in the liver, which can help reduce liver fat and inflammation in people with fatty liver disease and HIV. Unlike current treatments that mainly focus on managing symptoms or controlling related conditions, Resmetirom directly addresses the root cause by enhancing liver health. Researchers are excited because this approach could offer a more effective way to treat fatty liver disease, potentially improving liver function and overall health in patients with HIV.

What evidence suggests that resmetirom might be an effective treatment for fatty liver disease in people with HIV?

Research has shown that resmetirom, which participants in this trial may receive, can help reduce liver fat. In one study, liver fat levels dropped by about 19%, as seen in MRI scans. Another study found a 30% reduction in liver fat. Resmetirom targets specific receptors related to thyroid hormones, which helps decrease liver fat. The treatment has been safe and well-tolerated in people with fatty liver disease. While this trial focuses on people with HIV, earlier research suggests it could improve liver health. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV on stable antiretroviral therapy and diagnosed with MASLD, a type of fatty liver disease. They must have certain levels of liver stiffness and fat as measured by medical scans or tests, and their HIV must be well-controlled.

Inclusion Criteria

I am an adult with documented HIV.

My liver is stiff and has a high fat content.

I am willing to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 visits

3 visits (in-person)

Treatment

Participants take resmetirom or placebo every day for 24 weeks

24 weeks

3 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 phone call

What Are the Treatments Tested in This Trial?

Interventions

• Resmetirom

Trial Overview

The study is testing resmetirom against a placebo to see if it reduces liver fat in patients with MASLD and HIV. Participants will take the drug or placebo daily for 24 weeks, undergo MRI scans to measure liver fat before and after treatment, and attend clinic visits for bloodwork.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Resmetirom - 80mg or 100mg based on participant weight

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Naga P. Chalasani

Lead Sponsor

Trials

2

Recruited

220+

Citations

1.

nature.com

nature.com/articles/s41591-023-02603-1

Resmetirom for nonalcoholic fatty liver disease

These findings demonstrate resmetirom was safe and well tolerated in adults with presumed NASH, supporting a role for further clinical development.

2.

natap.org

natap.org/2022/HIV/HepatologyCommunications2021HarrisonEffectsofResmetiromonNoninvasiveEndpoints2010WeekPhase2Active(1).pdf

Effects of Resmetirom on Noninvasive Endpoints in a 36‐ ...

Resmetirom (MGL-3196), a selective thyroid hormone receptor-β agonist, was evaluated in a 36-week paired liver bi- opsy study (NCT02912260) in adults with ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212109925004522

Cost-Effectiveness of Resmetirom for Metabolic ...

Fibrosis improvement by at least one stage with no worsening of the nonalcoholic fatty liver disease activity score was achieved in 24.2% of the patients in the ...

4.

cureus.com

cureus.com/articles/390697-translating-trial-to-treatment-a-scoping-review-of-resmetirom-first-year-in-real-world-use-for-moderate-to-advanced-fibrosis-in-metabolic-dysfunction-associated-steatohepatitis

A Scoping Review of Resmetirom First Year in Real-World ...

Key clinical trials and real-world data from the United States show that Resmetirom is effective in treating MASH, lowering liver fat and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11374252/

Efficacy and safety of resmetirom among patients with non ...

Resmetirom shown a substantial improvement in MRI-PDFF with a MD of −19.23 (P<0.00001). Additionally, it resulted in a 30% reduction in fat (OR: ...

6.

natap.org

natap.org/2020/HIV/052820_01.htm

Fatty Liver in HIV

Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in patients with HIV Thus, all patients with chronically increased liver test panel results ...

7.

hcplive.com

hcplive.com/view/phase-3-maestro-nafld-1-data-resmetirom-mash-cirrhosis-with-naim-alkhouri-md

Phase 3 MAESTRO-NAFLD-1 Data for Resmetirom in ...

“After 2 years of treatment, we show reduction in liver stiffness measurement with FibroScan by 6.7 kilopascals. In my mind, this is very ...