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Farnesoid X receptor (FXR) agonist

Seladelpar for Liver Disease

Phase 1
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C
Be older than 18 years old
Must not have
Clinically significant or history of acute or chronic liver disease of an etiology other than PBC
Female subjects who are pregnant or nursing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial found that Seladelpar is safe and well tolerated in patients with PBC and HI.

Who is the study for?
This trial is for adults aged 18-80 with Primary Biliary Cholangitis (PBC) and liver cirrhosis, classified as CP-A to CP-C. Participants must have been on Ursodeoxycholic acid for at least 12 weeks, not be pregnant or nursing, and agree to use contraception. Exclusions include other liver diseases, recent infections requiring systemic therapy, significant ECG abnormalities, substance abuse within the last six months, and certain medication use.
What is being tested?
The study tests how different levels of liver impairment affect the body's handling of Seladelpar in PBC patients. It involves oral dosing with either a fixed dose of Seladelpar (10 mg) or a potentially lower amount based on individual tolerance.
What are the potential side effects?
While specific side effects are not listed here, participants can generally expect potential risks associated with medications affecting the liver which may include gastrointestinal symptoms like nausea or diarrhea, fatigue, itching (pruritus), abdominal pain and possible changes in blood tests related to liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PBC with cirrhosis and my liver function is classified as CP-A, CP-A + PHT, CP-B, or CP-C.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have liver disease not caused by primary biliary cholangitis.
Select...
I am not pregnant or nursing.
Select...
I need treatment for an infection before starting the trial.
Select...
I have both PBC and autoimmune hepatitis.
Select...
I haven't used any experimental treatments for PBC in the last 30 days.
Select...
I might have liver or bile duct cancer based on tests or symptoms.
Select...
I've been to the ER or hospital for cirrhosis complications in the last 3 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

Side effects data

From 2023 Phase 3 trial • 193 Patients • NCT04620733
18%
Covid-19
8%
Headache
7%
Abdominal pain
6%
Nausea
6%
Fatigue
6%
Abdominal distension
6%
Arthralgia
5%
Pruritus
5%
Nasopharyngitis
4%
Asthenia
3%
Pharyngitis
3%
Urinary tract infection
3%
Hypertension
1%
Papillary thyroid cancer
1%
Upper respiratory tract infection
1%
Invasive ductal breast carcinoma
1%
Oesophageal varices haemorrhage
1%
Femur fracture
1%
Rotator cuff syndrome
1%
Coagulopathy
1%
Coronary artery disease
1%
Duodenal obstruction
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dyspnoea exertional
1%
Vertigo positional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Seladelpar

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Seladelpar 10 mg or lessExperimental Treatment1 Intervention
Part B: Multiple oral dose of 10 mg or less
Group II: Seladelpar 10 mgExperimental Treatment1 Intervention
Part A: Single oral dose 10 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seladelpar 10 mg
2021
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,134 Previous Clinical Trials
867,935 Total Patients Enrolled
CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,232 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
360 Previous Clinical Trials
192,365 Total Patients Enrolled
~1 spots leftby Jan 2025
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