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Selective PPAR-delta agonist

Seladelpar for Primary Biliary Cholangitis (AFFIRM 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
Must have a confirmed prior diagnosis of PBC
Evidence of cirrhosis
Must not have
History of liver transplantation or actively listed for cadaveric or planned living donor transplant
Decompensated cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing Seladelpar, a medication that may help people with a specific liver disease called Primary Biliary Cholangitis (PBC) and early-stage cirrhosis. The drug aims to reduce liver inflammation and damage, potentially improving liver health. Seladelpar has shown promising results in previous studies for PBC, despite initial safety concerns.

Who is the study for?
This trial is for adults aged 18-75 with Primary Biliary Cholangitis (PBC) and compensated cirrhosis. Participants must have a Child-Pugh (CP) Score of A or B, use dual contraception methods, and be able to follow the study's procedures. Exclusions include those with conditions that may interfere with the study, prior liver transplants, decompensated cirrhosis, certain lab values outside set limits, or previous seladelpar exposure.
What is being tested?
The trial is testing Seladelpar at a dose of 10 mg against a placebo to see its effect on clinical outcomes in patients with PBC and compensated cirrhosis. The goal is to determine if Seladelpar can improve health markers in these patients compared to not receiving the active drug.
What are the potential side effects?
While specific side effects for Seladelpar are not listed here, similar medications often cause gastrointestinal symptoms like nausea or diarrhea, potential liver enzyme elevations, fatigue, itching (pruritus), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a liver transplant or am waiting for one.
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My liver is severely damaged and cannot function properly.
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My kidney function is reduced, with an eGFR below 45.
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My liver condition is classified as CP-C cirrhosis.
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I have or had other liver diseases besides my current condition.
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I have previously been treated with seladelpar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event Free Survival (EFS)
Secondary study objectives
Liver transplant-free survival
Overall survival
Time to Event Free Survival (EFS)
+1 more

Side effects data

From 2020 Phase 3 trial • 265 Patients • NCT03602560
9%
Abdominal pain upper
7%
Upper respiratory tract infection
6%
Arthralgia
6%
Constipation
6%
Dry mouth
6%
Nausea
6%
Headache
4%
Cough
4%
Diarrhoea
3%
Dry eye
3%
Pruritus
3%
Pruritus generalised
3%
Dyspepsia
3%
Nasopharyngitis
2%
Back pain
2%
Fatigue
2%
Urinary tract infection
2%
Sinusitis
1%
Muscle spasms
1%
Adenoid cystic carcinoma
1%
Leukocytosis
1%
Cognitive disorder
1%
Abdominal distension
1%
Insomnia
1%
Gastrooesophageal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Seladelpar 5/10 mg
Seladelpar 10 mg
Placebo

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
Placebo Group
Group I: SeladelparExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seladelpar
2019
Completed Phase 2
~10

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
The most common treatments for Primary Biliary Cirrhosis (PBC) include ursodeoxycholic acid (UDCA), fibrates, and statins. UDCA works by reducing the toxicity of bile acids, improving bile flow, and protecting liver cells, which is crucial for slowing disease progression. Fibrates, such as bezafibrate, activate peroxisome proliferator-activated receptors (PPARs) to reduce bile acid synthesis and improve lipid metabolism, offering benefits for patients with an incomplete response to UDCA. Statins lower cholesterol levels and may reduce liver inflammation, although their use is limited in patients with significant cholestasis. Seladelpar, a PPARδ agonist, is being studied for its ability to further enhance bile acid metabolism and reduce liver inflammation, potentially offering a more targeted and effective treatment option for PBC patients.
Fibrate treatment for primary biliary cirrhosis.

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,064 Total Patients Enrolled
4 Trials studying Primary Biliary Cholangitis
632 Patients Enrolled for Primary Biliary Cholangitis
Gilead SciencesLead Sponsor
1,129 Previous Clinical Trials
867,060 Total Patients Enrolled
5 Trials studying Primary Biliary Cholangitis
703 Patients Enrolled for Primary Biliary Cholangitis
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
191,917 Total Patients Enrolled
3 Trials studying Primary Biliary Cholangitis
245 Patients Enrolled for Primary Biliary Cholangitis
~128 spots leftby Jul 2029
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