What the trial was testing
The RESPONSE enrolled 193 patients with primary biliary cholangitis. The study was sponsored by Gilead Sciences and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
62% had a biochemical response on seladelpar vs. 20% on the comparison pill.
New England Journal of Medicine · 2024 · NCT04620733
These findings — that biochemical response at 12 months on seladelpar plus ursodeoxycholic acid — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 193 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with primary biliary cholangitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Seladelpar (Livdelzi) is FDA-approved and available now for primary biliary cholangitis when ursodeoxycholic acid is not enough. It also reduced the moderate-to-severe itching that drives many PBC patients up the wall. Ask a hepatologist about adding it to your existing regimen.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open primary biliary cholangitis trials
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.