Seladelpar for Liver Disease

No longer recruiting at 35 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must be taking: Ursodeoxycholic acid

Must not be taking: Obeticholic acid, Fibrates

Disqualifiers: Other liver disease, Hepatobiliary malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Seladelpar for Primary Biliary Cholangitis (PBC), a liver disease that can lead to liver damage and cirrhosis. The trial aims to determine how individuals with liver impairment metabolize the medication after oral administration. Participants will receive either a single dose or multiple doses of Seladelpar to observe these effects. This trial may suit individuals diagnosed with PBC and cirrhosis who have taken Ursodeoxycholic acid (a medication for PBC) for at least 12 weeks. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking obeticholic acid, any drug of the same class, or fibrates at least 30 days before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the study team.

Is there any evidence suggesting that Seladelpar is likely to be safe for humans?

Research shows that seladelpar has promising safety results for people with primary biliary cholangitis (PBC). Earlier studies demonstrated that seladelpar improved liver health with minimal side effects. At a daily dose of 10 mg, it reduced symptoms like itching and markers of liver damage.

Although this trial remains in the early stages, with safety data still being collected, seladelpar is already approved for treating PBC. This approval suggests it is generally well-tolerated, but ongoing studies are important to confirm its safety in various situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Seladelpar is unique because it targets the liver condition with a new mechanism of action. Unlike most treatments that focus on reducing symptoms, Seladelpar works by activating a specific receptor called PPAR-delta, which plays a crucial role in reducing inflammation and fat accumulation in the liver. This direct targeting of liver cells might lead to more effective management of the disease. Researchers are excited about Seladelpar because it offers a potential new pathway for treating liver disease, which could improve outcomes for patients who haven't responded well to existing therapies.

What evidence suggests that Seladelpar might be an effective treatment for liver disease?

Research has shown that seladelpar effectively treats primary biliary cholangitis (PBC), a liver disease. In one study, 62% of patients experienced significant improvements in liver function. Seladelpar reduces inflammation in the liver's bile ducts, improves liver enzyme levels, and lowers the risk of needing a liver transplant or experiencing severe liver issues. Another study found that seladelpar significantly improved important lab results related to PBC, such as reducing alkaline phosphatase (ALP), an enzyme linked to liver damage, and easing itchiness, a common symptom. These studies suggest that seladelpar can effectively help manage PBC. Participants in this trial will receive either a single oral dose of 10 mg or multiple oral doses of 10 mg or less to further evaluate its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Screening laboratory parameters: ALP, ALT and AST < 10 × ULN, Total bilirubin ≤ 5 × ULN, Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1, At screening confirmed diagnosis of PBC, MELD-Na scores of 6 to 24

I have PBC with cirrhosis and my liver function is classified as CP-A, CP-A + PHT, CP-B, or CP-C.

I am willing to use birth control during and for 30 days after the study if I can have children and am sexually active.

Exclusion Criteria

I have liver disease not caused by primary biliary cholangitis.

I am not pregnant or nursing.

I need treatment for an infection before starting the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single oral dose of 10 mg Seladelpar

1 day

Treatment Part B

Participants receive multiple oral doses of 10 mg or less Seladelpar

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Seladelpar

Trial Overview 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.

How Is the Trial Designed?

Group I: Seladelpar 10 mg or less Experimental Treatment 1 Intervention

Part B: Multiple oral dose of 10 mg or less

Group II: Seladelpar 10 mg Experimental Treatment 1 Intervention

Part A: Single oral dose 10 mg

Seladelpar is already approved in United States, European Union for the following indications:

Approved in United States as Livdelzi for:

• Primary biliary cholangitis

Approved in European Union as Livdelzi for:

• Primary biliary cholangitis

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

CymaBay Therapeutics, Inc.

Lead Sponsor

Trials

23

Recruited

3,200+

Citations

1. gilead.com gilead.com/news/news-details/2025/gilead-to-showcase-interim-long-term-efficacy-data-for-livdelzi-seladelpar-in-primary-biliary-cholangitis-pbc-and-investigational-bulevirtide-in-chronic-hepatitis-delta

Gilead to Showcase Interim Long Term Efficacy Data for ... - New Three-Year Interim Data Demonstrates Livdelzi® May Help Stabilize or Improve Liver Health in PBC Patients -. FOSTER CITY, Calif ...

2. livdelzihcp.com livdelzihcp.com/efficacy-pruritus

Efficacy Data | LIVDELZI® (seladelpar) 62% of patients achieved biochemical response with LIVDELZI 1. RESPONSE was a 12-month, randomized, double-blind phase 3 pivotal trial that assessed the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394184/

The Efficacy and Safety of Seladelpar for Primary Biliary ... It works mainly by reducing ductal inflammation, improving liver enzyme levels, and decreasing the risk of liver transplantation or death [6].

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02955602

Study Details | NCT02955602 | Seladelpar (MBX-8025) in ... The UK-PBC Risk Score at endpoint is defined by the mean percentage risk that a PBC patient treated with ursodeoxycholic acid (UDCA) would develop liver failure ...

5. livdelzi.com livdelzi.com/results

Clinical Trial Results | LIVDELZI® (seladelpar) In the clinical trial, LIVDELZI significantly improved key primary biliary cholangitis (PBC) lab results and reduced both alkaline phosphatase (ALP) and itch.

6. va.gov va.gov/formularyadvisor/DOC_PDF/MON_Seladelpar_LIVDELZI_in_Primary_Biliary_Cholangitis_Monograph_Jan_2025.pdf

Seladelpar (LIVDELZI) in Primary Biliary Cholangitis ... At an optimal dose of 10 mg daily, seladelpar produced clinically significant anticholestatic effects and reduced signs of liver injury and pruritus in patients ...