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Farnesoid X receptor agonist

Seladelpar for Primary Biliary Cholangitis (IDEAL Trial)

Phase 3

Recruiting

Research Sponsored by CymaBay Therapeutics, Inc.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

IDEAL 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.Check my eligibility

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.See study design

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.

IDEAL Trial 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.

IDEAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects who achieve normalization of ALP (ALP ≤ ULN) and ≥ 15% decrease.

Type and frequency of treatment-emergent adverse events in seladelpar vs placebo treated subjects.

IDEAL 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor

22 Previous Clinical Trials

3,106 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current regulatory status of Seladelpar 10 mg?

"Seladelpar 10 mg has been given a safety score of 3, as the Phase 3 trial indicates that it is both efficacious and safe."

Answered by AI

Does this clinical research require participants to be of a certain age?

"Participants in this medical study must be between 18 and 75 years old. Alternatively, there are 6 trials targeting minors, while those over 65 can partake of the 59 studies available for them."

Answered by AI

To whom is access to this trial available?

"The requirements to enter this trial are primary biliary cirrhosis and being between 18-75 years old. Presently, 75 patients have been enrolled in the study."

Answered by AI

Is enrollment still open for this trial?

"Correct. According to clinicaltrials.gov, this research endeavor is actively seeking participants since its posting on September 5th 2023 and subsequent edits on the 25th of that same month. A total of 75 patients need to be recruited from 4 distinct medical centres."

Answered by AI

Could you provide details on where the clinical trial is being conducted within North America?

"Four medical centres are conducting this trial: South Denver Gastroenterology, PC (Englewood); Digestive Healthcare of Georgia, P.C. (Atlanta); Mercy Medical Center (Baltimore) and other four sites have yet to be disclosed."

Answered by AI

How many individuals is this research project accepting?

"CymaBay Therapeutics, Inc. is responsible for the trial's execution and requires 75 participants that meet its eligibility criteria. South Denver Gastroenterology, PC in Englewood, Colorado and Digestive Healthcare of Georgia, P.C. will both be hosting sites for this clinical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

2023. "IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060665.

All > Liver Cirrhosis > Primary Biliary Cirrhosis