What is the mechanism of action of this treatment?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include antifibrotic agents, such as BMS-986263, which aim to prevent or reduce liver fibrosis by targeting hepatic stellate cells and other fibrogenic pathways. These agents work by inhibiting the activation and proliferation of stellate cells, reducing collagen deposition, and modulating inflammatory responses. Additionally, lifestyle interventions like diet and exercise, and medications such as pioglitazone and vitamin E, help reduce liver fat and inflammation. These treatments are crucial for NAFLD patients as they address the underlying mechanisms of disease progression, potentially preventing the development of cirrhosis and improving liver function.

What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, lipid-lowering agents, and antifibrotic agents. Lifestyle changes such as diet and exercise are generally safe but may be challenging to maintain. Lipid-lowering agents like statins are effective but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Antifibrotic agents, such as those being studied in trials like BMS-986263, aim to reduce liver fibrosis. While specific side effects of BMS-986263 are not detailed, antifibrotic agents can potentially cause gastrointestinal issues, liver enzyme elevations, and fatigue. Further studies are needed to fully understand their safety profile.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or its more severe form, Non-alcoholic Steatohepatitis (NASH). However, several drugs are under investigation, including antifibrotic agents like BMS-986263. Other investigational treatments include obeticholic acid, a farnesoid X receptor agonist, and elafibranor, a dual PPAR alpha/delta agonist, both of which aim to reduce liver inflammation and fibrosis. These drugs are in various stages of clinical trials and have shown promise in improving liver histology in patients with NASH.

What other types of research exist?

Promising alternatives to BMS-986263 for NAFLD patients include EW-7197, which inhibits TGF-β/Smad and ROS signaling pathways, and FR260330, a selective inducible nitric oxide synthase (iNOS) inhibitor that reduces liver fibrosis by inhibiting transforming growth factor-beta1.

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BMS-986263 for Nonalcoholic Steatohepatitis

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Known immunocompromised status or any disease or condition which might compromise participant safety

Prior exposure to BMS-986263

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment to end of follow up (36 weeks)

Summary

This trial is testing a new drug called BMS-986263 to see if it is safe and effective for adults with chronic liver disease caused by fatty liver disease. The drug aims to help the liver work better and heal from damage.

Who is the study for?

This trial is for adults with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Participants must have a specific liver fibrosis score and agree to use contraception. Those with compromised immune systems, prior exposure to BMS-986263, hepatic decompensation, or other conditions that may risk safety are excluded.

What is being tested?

The study is testing the safety and effectiveness of BMS-986263 compared to a placebo in treating liver disease caused by NASH. It's randomized, meaning participants will be randomly assigned to receive either the drug or a placebo without choosing which one.

What are the potential side effects?

Potential side effects of BMS-986263 could include reactions at the injection site, changes in liver function tests, fatigue, gastrointestinal symptoms like nausea or diarrhea, and possibly allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that weakens my immune system.

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I have previously been treated with BMS-986263.

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My liver is not working properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment to end of follow up (36 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first treatment to end of follow up (36 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment to end of follow up (36 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score), as Determined by Liver Biopsy After 12 Weeks of Treatment.

Secondary study objectives

Mean Change From Baseline in CPA After 12 Weeks of Treatment

Number of Participants With Clinically Significant Changes in BMD.

Number of Participants With Clinically Significant Changes in Clinical Laboratory Values.

+9 more

Side effects data

From 2019 Phase 2 trial • 61 Patients • NCT03420768

33%

Infusion related reaction

11%

Headache

Tendonitis

Hypothyroidism

Abulia

Upper respiratory tract infection

Vulvovaginal candidiasis

100%

80%

60%

40%

20%

Study treatment Arm

BMS-986263 45 mg QW (Once Weekly)

Placebo QW (Once Weekly)

BMS-986263 90 mg QW (Once Weekly)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose B BMS-986263Experimental Treatment1 Intervention

Group II: Dose A BMS-986263Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986263

2020

Completed Phase 2

~140

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include antifibrotic agents, such as BMS-986263, which aim to prevent or reduce liver fibrosis by targeting hepatic stellate cells and other fibrogenic pathways. These agents work by inhibiting the activation and proliferation of stellate cells, reducing collagen deposition, and modulating inflammatory responses. Additionally, lifestyle interventions like diet and exercise, and medications such as pioglitazone and vitamin E, help reduce liver fat and inflammation. These treatments are crucial for NAFLD patients as they address the underlying mechanisms of disease progression, potentially preventing the development of cirrhosis and improving liver function.

Relevant Aspects of Nutritional and Dietary Interventions in Non-Alcoholic Fatty Liver Disease.Prevention of hepatic fibrosis in a murine model of metabolic syndrome with nonalcoholic steatohepatitis.