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Farnesoid X receptor (FXR) agonist

INT-787 for Alcoholic Hepatitis (FRESH Trial)

Phase 2
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up baseline and at day 7, 14, 21, 28
Awards & highlights

FRESH Trial Summary

This trial will assess safety, efficacy, and how the body processes a drug for severe alcohol-related hepatitis.

Who is the study for?
Adults aged 18-65 with severe alcohol-associated hepatitis (sAH) can join this trial. They must have a history of heavy drinking, specific blood test results indicating liver inflammation, and agree to contraception or abstinence. Those unable to make decisions due to hepatic encephalopathy need consent from a legal representative.Check my eligibility
What is being tested?
The FRESH study is testing the safety and effectiveness of a drug called INT-787 in different doses for patients with sAH. It will also look at how the body processes the drug. Participants are monitored for their response to treatment and any changes in their condition.See study design
What are the potential side effects?
Potential side effects of INT-787 aren't specified but may include reactions related to liver function, digestive issues, or other unexpected health concerns as it's being studied for its safety profile.

FRESH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at day 7, 14, 21, 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at day 7, 14, 21, 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lille model response based on Lille score by treatment group
Secondary outcome measures
Change from Baseline in total bilirubin
Change from baseline in the Model for End-Stage Liver Disease (MELD) score at 28-days by treatment group
Difference in 28-day, 56-day, and 84-day mortality or liver transplantation between INT-787 and placebo
+5 more

FRESH Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: INT-787Active Control1 Intervention
Participants will be randomized to receive INT-787 (escalating doses through the cohorts)
Group II: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive matching placebo

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 Alcoholic Hepatitis, such as S-adenosyl-L-methionine (SAMe), focus on reducing inflammation, preventing fibrosis, and protecting liver cells. SAMe works by replenishing glutathione levels, which helps detoxify harmful substances in the liver, reducing oxidative stress and inflammation. Anti-inflammatory agents aim to decrease liver inflammation, while anti-fibrotic treatments target the reduction of scar tissue formation by inhibiting stellate cell activation. Hepatoprotective agents help in maintaining liver cell integrity and function. These mechanisms are crucial for Alcoholic Hepatitis patients as they help in slowing disease progression, improving liver function, and potentially delaying the need for more invasive treatments like liver transplantation.
Alcoholic liver disease patients treated with S-adenosyl-L-methionine: an in-depth look at liver morphologic data comparing pre and post treatment liver biopsies.

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
27 Previous Clinical Trials
16,800 Total Patients Enrolled

Media Library

INT-787 (Farnesoid X receptor (FXR) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05639543 — Phase 2
Alcoholic Hepatitis Research Study Groups: INT-787, Placebo
Alcoholic Hepatitis Clinical Trial 2023: INT-787 Highlights & Side Effects. Trial Name: NCT05639543 — Phase 2
INT-787 (Farnesoid X receptor (FXR) agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639543 — Phase 2
~12 spots leftby Dec 2024