Alcohol Associated HepatitisPhase 2FRESHNCT05639543
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
A Phase 2 study testing INT-787 in people with Alcohol Associated Hepatitis, run by Intercept Pharmaceuticals at 29 sites in 3 countries.
Trial summary
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Associated Hepatitis
- What is being tested?
- INT-787
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 15 Dec 2022to 10 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 65 years (inclusive)
- Clinical diagnosis of sAH based on all the following:
- History of ongoing excess alcohol (>60 g/day [male] or >40 g/day [female]) use for ≥6 months, with <60 days of abstinence prior to the onset of jaundice
- Serum total bilirubin >3.0 mg/dL
- Aspartate aminotransferase (AST) ≥50 U/L
- AST/Aspartate aminotransferase (ALT) ratio ≥1.5
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- Onset of jaundice within prior 8 weeks
- Cohort 1 through Cohort 4: Maddrey's Discriminant Factor (mDF) ≥32 and ≤70
- Cohort 5 and Cohort 6: mDF ≥32
- Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
- Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows:
- Surgical sterilization (bilateral tubal occlusion, etc.)
- Placement of an intrauterine device (IUD) or intrauterine system (e.g., intrauterine hormone-releasing system [IUS])
- Combined (estrogen and progesterone containing) hormonal contraceptive associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
- Progesterone-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Sexual abstinence: When in line with the preferred and usual lifestyle of the participant, is defined as avoiding all types of activity that could result in conception (pregnancy) from the initiation of Screening and until at least 90 days after the last dose of investigational product
Who cannot join
- Participants taking products containing obeticholic acid in the 30 days prior to randomization
- Participants taking >2 doses of systemic corticosteroids within 30 days prior to randomization.
- Participants who have been inpatient at a referral hospital for >7 days prior to transfer.
- Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
- Abstinence from alcohol consumption for >2 months before Day 1.
- AST or ALT >400 U/L.
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- Cohort 1 through Cohort 4: mDF <32 or >70.
- Cohort 5 and Cohort 6: mDF <32
- Cohort 1 through Cohort 4: MELD score <18 or >25.
- Cohort 5 and Cohort 6: MELD <21 or >30
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C virus (HCV) RNA positive, drug-induced liver injury (DILI), biliary obstruction, and autoimmune liver disease.
- Current or previous history of hepatocellular carcinoma (HCC)
- History of liver transplantation or currently listed for liver transplant
- Note: Additional protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States20 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Henry Ford Health System
Detroit, Michigan, 48202
University of California, San Francisco-Fresno
Fresno, California, 93701
Baylor College of Medicine
Houston, Texas, 77030
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030
Clinical Translational Research Site
Miami, Florida, 33136
Vanderbilt Digestive Disease Center
Nashville, Tennessee, 37232
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Stanford Healthcare
Palo Alto, California, 94305
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
VCU Health Clinical Research Services Unit
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Hospital
Salt Lake City, Utah, 84132
Tampa General Medical Group
Tampa, Florida, 33606
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
France5 sites
CHU Angers
Angers, 49933
Hopital Beaujon
Clichy, 92118
Hopital Claude Huriez
Lille, 59037
Hopital Pitie Salpetriere
Paris, 75013
Hopital Rangueil
Toulouse, 31059
United Kingdom4 sites
Cambridge University NHS Foundation Trust
Cambridge
Royal Free Hospital
London, NW3 2QG
Imperial College Healthcare NHS Trust
London
University Hospitals Plymouth NHS Trust
Plymouth
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects With Severe Alcohol Associated Hepatitis
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
Read the detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, proof-of-concept study to evaluate the safety, tolerability, efficacy, and PK of INT-787 in participants, initially admitted to the hospital, with severe alcohol-associated hepatitis (sAH). The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target population of participants with sAH. INT-787 will be evaluated for safety and tolerability prior to dose escalation. Overall efficacy, compared to placebo, will be assessed for each dose cohort.
Additionally, PK measurements at various study timepoints will allow the Sponsor to better understand the systemic exposure of INT-787 and the relationship between exposure and efficacy and safety. Such insights in participants with more advanced liver disease will provide valuable information for future clinical trials of INT-787.
The placebo-treated participants will provide important natural history information on outcomes in this participant population with sAH treated with supportive care. The placebo-treated participants within cohorts are meant to blind the study drug administration while the data across dose cohorts will be used in the overall analysis.
- Conditions
- Alcohol Associated Hepatitis
- Being tested
- INT-787, Placebo
- Keywords
- Severe Alcohol associated Hepatitis (sAH), Alcoholic Hepatitis (AH), Hepatitis, Alcoholic
- Medical subject headings
- Hepatitis, Alcoholic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT-787Drug
Blinded Study Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| INT-787 | Active comparator | Participants will be randomized to receive INT-787 (in Dose Escalation Cohorts [Cohorts 1 through 4] and Extension Phase Cohorts [Cohorts 5 and 6]) Receives: Drug: INT-787 |
| Placebo | Placebo comparator | Participants will be randomized to receive matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lille model response based on Lille score by treatment group
The Lille score response rate will be analyzed as a categorical variable. Participants with Lille score <0.45 will be counted as responders and those with Lille score ≥0.45 will be counted as non-responders.
Measured: Day 7
Secondary outcomes (5)
Change from baseline in the Model for End-Stage Liver Disease (MELD) score at 28-days by treatment group
The MELD scoring system is used to assess the severity of liver disease in participants in the setting of alcohol-associated hepatitis. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and international normalized ratio (INR). The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.
Measured: Baseline and at Day 28
Change from Baseline in total bilirubin
Measured: Baseline and at Day 7, 14, 21, 28, 56 and 84
Difference in 28-day, 56-day, and 84-day all-cause mortality or liver transplantation (TFS) between INT-787 and placebo
Measured: Day 28, 56, 84
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and treatment emergent adverse event of special interest (AESIs)
Measured: During the study period, up to 12 weeks
Number of participants reporting infectious adverse events by System organ class (SOC)/ preferred term by treatment group
Measured: During the study period, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Dec 2022
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Why it stopped: Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Associated HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639543
- Sponsor's protocol ID
- 787-201
- Acronym
- FRESH
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects With Severe Alcohol Associated Hepatitis
- ClinicalTrials.gov ID
- NCT05639543
- Acronym / sponsor ID
- FRESH / 787-201
- Conditions
- Alcohol Associated Hepatitis
- Keywords
- Severe Alcohol associated Hepatitis (sAH), Alcoholic Hepatitis (AH), Hepatitis, Alcoholic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
Detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, proof-of-concept study to evaluate the safety, tolerability, efficacy, and PK of INT-787 in participants, initially admitted to the hospital, with severe alcohol-associated hepatitis (sAH). The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target population of participants with sAH. INT-787 will be evaluated for safety and tolerability prior to dose escalation. Overall efficacy, compared to placebo, will be assessed for each dose cohort.
Additionally, PK measurements at various study timepoints will allow the Sponsor to better understand the systemic exposure of INT-787 and the relationship between exposure and efficacy and safety. Such insights in participants with more advanced liver disease will provide valuable information for future clinical trials of INT-787.
The placebo-treated participants will provide important natural history information on outcomes in this participant population with sAH treated with supportive care. The placebo-treated participants within cohorts are meant to blind the study drug administration while the data across dose cohorts will be used in the overall analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INT-787 | Active comparator | Drug: INT-787Participants will be randomized to receive INT-787 (in Dose Escalation Cohorts [Cohorts 1 through 4] and Extension Phase Cohorts [Cohorts 5 and 6]) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Males or females aged 18 to 65 years (inclusive)
- Clinical diagnosis of sAH based on all the following:
- Cohort 1 through Cohort 4: MELD score ≥18 to ≤25 (inclusive) and Cohort 5 and Cohort 6: MELD score ≥21 to ≤30
- Female participants must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), be prepared to use ≥1 highly effective method of contraception from the initiation of Screening and for 90 days after the last dose of investigational product as follows:
Key exclusion criteria (14 listed)
- Participants taking products containing obeticholic acid in the 30 days prior to randomization
- Participants taking >2 doses of systemic corticosteroids within 30 days prior to randomization.
- Participants who have been inpatient at a referral hospital for >7 days prior to transfer.
- Pregnancy, planned pregnancy, potential for pregnancy (e.g., unwillingness to use effective birth control during the study), or current or planned breast feeding.
- Abstinence from alcohol consumption for >2 months before Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INT-787Blinded Study Drug | Drug | INT-787 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Lille model response based on Lille score by treatment group
Time frame: Day 7
The Lille score response rate will be analyzed as a categorical variable. Participants with Lille score <0.45 will be counted as responders and those with Lille score ≥0.45 will be counted as non-responders.
5 secondary outcomes
Change from baseline in the Model for End-Stage Liver Disease (MELD) score at 28-days by treatment group
Time frame: Baseline and at Day 28
Change from Baseline in total bilirubin
Time frame: Baseline and at Day 7, 14, 21, 28, 56 and 84
Difference in 28-day, 56-day, and 84-day all-cause mortality or liver transplantation (TFS) between INT-787 and placebo
Time frame: Day 28, 56, 84
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and treatment emergent adverse event of special interest (AESIs)
Time frame: During the study period, up to 12 weeks
Number of participants reporting infectious adverse events by System organ class (SOC)/ preferred term by treatment group
Time frame: During the study period, up to 12 weeks
Results and safety
The study was stopped early (reason given: Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INT-787 in people with Alcohol Associated Hepatitis, run by Intercept Pharmaceuticals at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Intercept made the business decision to terminate the study on 31 Mar 2026 as there was no clear evidence of potential benefit of INT-787 in sAH. This decision was not based on a safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lille model response based on Lille score by treatment group (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.