Study summary

A PPAR-delta pill brought liver tests under control and eased itching

RESPONSE trial (seladelpar) · 193 people, phase 3 · Published February 2024, New England Journal of Medicine; FDA accelerated approval August 2024

61.7%biochemical response at 12 months, vs 20.0% with placebo

What was tested

Seladelpar, a once-daily PPAR-delta agonist, against placebo, added to ursodiol for primary biliary cholangitis that had not responded well enough to ursodiol alone.

What they found

Biochemical response was 61.7% vs 20.0%.
Alkaline phosphatase normalized in 25.0% vs 0%.
Itching improved more (-3.2 vs -1.7 points).

What it means

One of two new second-line drugs that largely replaced obeticholic acid.

N Engl J Med, via PubMed ↗ ← Back to the outlook

Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.