# Madrigal Plans MASH Cirrhosis Trial With More Than 2,000 Patients for 2027

By John Kim

Canonical URL: https://www.tokenpost.com/news/business/48432
Published: 2026-11-04T11:36:29.000Z
Updated: 2026-11-04T11:36:29.000Z
Section: Business

> The planned Phase 3 MAESTRO-CSPH study is targeted to start in the first half of 2027, pending regulatory discussions. Madrigal expects results in the early 2030s.

Madrigal Pharmaceuticals plans a second Phase 3 study of compensated MASH cirrhosis with more than 2,000 patients, while data from its ongoing outcomes trial are expected in late 2027. The plans extend the company’s clinical program in a patient group with advanced liver disease.

The planned MAESTRO-CSPH study is expected to enroll patients with F4c disease, the designation for compensated MASH cirrhosis. Its population is expected to be enriched for clinically significant portal hypertension (CSPH). Madrigal is targeting a start in the first half of 2027, pending regulatory discussions, and expects results in the early 2030s.

The first-half 2027 window is a target, not a specific start date. The study’s enrollment and results timing remain forward-looking plans, with the start dependent on regulatory discussions. MAESTRO-CSPH is planned as a separate outcomes trial from MAESTRO-NASH OUTCOMES, which is already underway.

MAESTRO-NASH OUTCOMES is an event-driven Phase 3 trial assessing progression to liver decompensation among patients with compensated MASH cirrhosis who receive Rezdiffra or a placebo. Its primary endpoint is liver-related clinical outcomes, and the trial is listed at 845 patients. Because the study is event-driven, its readout depends on accumulating enough clinical events.

Chief Executive William Sibold said the company would continue the study if it had not reached the required event count: “If we don't have the right number of events, we're just not going to stop the study.” The company expects data in late 2027, though the event-driven design makes that timing dependent on when the required events accrue.

Rezdiffra (resmetirom) has U.S. approval for adults with noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis) and moderate-to-advanced fibrosis at stages F2 to F3. Positive MAESTRO-NASH OUTCOMES results could support full U.S. Food and Drug Administration approval for noncirrhotic MASH and an additional indication for compensated MASH cirrhosis.