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Farnesoid X receptor agonist

Seladelpar for Primary Biliary Cholangitis (IDEAL Trial)

Phase 3
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.
18 to 75 years old (inclusive)
Must not have
Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
Previous exposure to seladelpar (MBX-8025)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial will study if a new drug, Seladelpar, can help treat PBC, a liver disease, in people who have not fully responded to other treatments.

Who is the study for?
This trial is for adults aged 18-75 with Primary Biliary Cholangitis (PBC) who haven't fully responded to or can't tolerate Ursodeoxycholic Acid. Participants must have certain levels of alkaline phosphatase, use dual contraception methods if they're of reproductive potential, and not have a history of drug abuse or recent treatments that could interfere with the study.
What is being tested?
The IDEAL trial is testing whether Seladelpar can normalize alkaline phosphatase levels in PBC patients compared to a placebo. It's designed for those who don’t respond well to standard treatment. The participants will be randomly assigned either Seladelpar 10 mg or a placebo.
What are the potential side effects?
Potential side effects from Seladelpar may include digestive issues, liver enzyme changes, fatigue, itching (pruritus), abdominal pain, and rash. As it targets liver function specifically, monitoring for any liver-related symptoms would be particularly important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using two forms of birth control during and 90 days after the study.
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I am between 18 and 75 years old.
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I have been diagnosed with primary biliary cholangitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used experimental treatments or devices recently.
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I have been treated with seladelpar before.
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My condition meets the advanced stage criteria for primary biliary cholangitis.
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I have significant liver function issues.
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I have HIV or tested positive for HIV antibodies.
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I haven't taken colchicine, methotrexate, azathioprine, or steroids in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Seladelpar 10 mgExperimental Treatment1 Intervention
Group II: PlaceboExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Seladelpar 10 mg
2021
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,130 Previous Clinical Trials
866,977 Total Patients Enrolled
5 Trials studying Primary Biliary Cholangitis
745 Patients Enrolled for Primary Biliary Cholangitis
CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,106 Total Patients Enrolled
4 Trials studying Primary Biliary Cholangitis
674 Patients Enrolled for Primary Biliary Cholangitis
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
191,966 Total Patients Enrolled
3 Trials studying Primary Biliary Cholangitis
287 Patients Enrolled for Primary Biliary Cholangitis
~69 spots leftby Dec 2025
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