What side effects are associated with this type of intervention?

Common treatments for Primary Biliary Cirrhosis (PBC) include ursodeoxycholic acid (UDCA) and obeticholic acid. UDCA is generally well-tolerated but can cause weight gain and, rarely, hair thinning. Obeticholic acid, a more potent bile acid receptor agonist, can lead to pruritus (itching), fatigue, and abdominal pain. Fibrates, such as fenofibrate and bezafibrate, which are PPAR agonists like Seladelpar, have been shown to improve liver biochemistries but can cause gastrointestinal disturbances, increased serum creatinine, and potential muscle-related side effects. Seladelpar, being a PPARδ agonist, is expected to have a similar side effect profile, including potential liver enzyme elevations and muscle-related issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Primary Biliary Cirrhosis (PBC), focusing primarily on ursodeoxycholic acid (UDCA) and obeticholic acid (OCA). UDCA has been the standard treatment for many years, helping to improve liver function and delay disease progression. Obeticholic acid, a farnesoid X receptor (FXR) agonist, was approved more recently for patients who do not respond adequately to UDCA. While Seladelpar, a PPARδ agonist, is still under investigation, it represents a novel approach targeting different pathways involved in PBC.

What other types of research exist?

Promising alternatives to Seladelpar for PBC patients include Ursodeoxycholic Acid (UDCA), which has been shown to ameliorate pruritus and improve liver function, and Bezafibrate, which has demonstrated efficacy in reducing symptoms and improving biochemical markers in PBC patients. Additionally, ongoing research into fibrates and other bile acid binding agents may offer new therapeutic options.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Abdominal pain upper

Upper respiratory tract infection

Arthralgia

Constipation

Dry mouth

Nausea

Headache

Cough

Diarrhoea

Dry eye

Pruritus

Pruritus generalised

Dyspepsia

Nasopharyngitis

Urinary tract infection

Back pain

Fatigue

Sinusitis

Muscle spasms

Adenoid cystic carcinoma

Leukocytosis

Cognitive disorder

Abdominal distension

Insomnia

Gastrooesophageal reflux disease

100%

80%

60%

40%

20%

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

0 / 10Eligibility criteria met

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.