Elafibranor, a dual PPAR-α/δ agonist, was evaluated in a 12-week double-blind randomized-controlled trial (ELMWOOD) for patients with primary sclerosing cholangitis (PSC).
The drug was generally well tolerated with a safety profile comparable to placebo, and serious adverse events occurred only in the placebo group.
Significant reductions in alkaline phosphatase (ALP), a key biomarker of cholestasis, were observed with elafibranor at both 80 mg and 120 mg doses compared to placebo.
The higher 120 mg dose produced a greater magnitude of ALP reduction and showed potential stabilization of fibrosis markers, supporting the rationale for larger, longer-term studies.
Study Background
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