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# Madrigal Plans A 2,000-Patient Cirrhosis Trial, Saying It's What 'Leaders In A Space' Do
- URL: https://www.bullished.co/madrigal-plans-a-2-000-patient-cirrhosis-trial-saying-its-what-leaders-in-a-space-do-27444161/
- Published: 2026-11-03T14:28:51.000Z
- Updated: 2026-11-03T14:28:51.000Z
- Description: CEO Bill Sibold defended a second outcomes trial on the earnings call and pointed to late 2027 for the first trial's readout.
- Author: Matteo Parrino
- Tags: Earnings, MDGL, Industry: Healthcare

Madrigal Pharmaceuticals, maker of the MASH liver-disease pill Rezdiffra, plans a second, larger Phase III trial in cirrhosis, and CEO Bill Sibold said on the company's third-quarter earnings call Tuesday that this is what "leaders in a space" do. The company also now expects the readout of its first cirrhosis outcomes trial in late 2027, as it reported [$431.3 million in quarterly net sales](https://www.9news.com/article/syndication/associatedpress/madrigal-q3-earnings-snapshot/616-b776533c-e975-4e77-87fc-09f61f8b3fe1?ref=bullished.co), up 50% from a year earlier.

## A second trial, built to lead

Chief Medical Officer Dave Soergel said the new trial, Maestro CSPH, will enroll more than 2,000 patients enriched for clinically significant portal hypertension, a critical inflection point in compensated cirrhosis. The company plans to finalize the protocol after talks with the FDA and start in the first half of 2027, with results expected in the early 2030s.

Together with the existing 845-patient Maestro NASH outcomes trial, the program would reach about 3,000 patients. Sibold called the new study "a practice-shaping trial that is a leapfrog study" and said Madrigal will "raise the bar for the entire industry." He added that the company is "building a mega blockbuster here."

Asked why start now, Sibold said many companies would wait, but Madrigal wants "no daylight" between anyone potentially launching and its generating new data. He said competitors have enlarged studies and delayed timelines, with the earliest potential entrant not expected until 2030.

## Late 2027, with events deciding

Pressed on whether late 2027 could slide into 2028, Sibold said the trial is event-driven and that if the right number of events has not occurred by December 31, 2027, "we're just not going to stop the study." He said the company would update investors if anything changes.

Soergel said the company is not giving event-accrual specifics because trials of this modest size "tend to be a bit choppy." He said dropout rates are within expectations, and that about 25 to 30 percent of patients were on stable GLP-1 therapy at the start; adding one for weight loss would be a protocol deviation.

An analyst noted that controlled studies have reported placebo event rates of roughly 2 to 3%. Soergel said the company has talked about 5% to 10% because F4C, compensated cirrhosis, is "not a monolithic disease," and that experience from the first trial lets it enrich for portal hypertension more effectively.

## A bigger market estimate and first profit

Madrigal now estimates 360,000 addressable F4C patients in the U.S., which Sibold said is up more than 45% from the 245,000 it previously shared and could double Rezdiffra's opportunity.

The quarter was Madrigal's first profitable one, with net income of [$55.4 million](https://www.9news.com/article/syndication/associatedpress/madrigal-q3-earnings-snapshot/616-b776533c-e975-4e77-87fc-09f61f8b3fe1?ref=bullished.co) against a net loss of $114.2 million a year earlier. Cash stood at $961.8 million, and CFO Mardi Dier said the company can self-fund the new trial, though it may dip in and out of profitability near term. Madrigal also plans three Phase II combination trials in 2027.

Dier said the company is not providing 2027 guidance, while the Maestro CSPH protocol awaits finalization after FDA talks ahead of a first-half 2027 start.

Learn

- [How To Read An Earnings Call Transcript: Start With Guidance, Then Find What's Missing →](https://www.bullished.co/learn/how-to-read-an-earnings-call/)  
How to read an earnings call transcript: check guidance first, look for dropped metrics, compare growth with last quarter, and watch hedged wording.

### Sources

- [Madrigal: Q3 Earnings Snapshot | 9news.com](https://www.9news.com/article/syndication/associatedpress/madrigal-q3-earnings-snapshot/616-b776533c-e975-4e77-87fc-09f61f8b3fe1?ref=bullished.co) — Associated Press
- [Madrigal (MDGL) Q3 Earnings and Revenues Beat Estimates](https://finance.yahoo.com/markets/stocks/articles/madrigal-mdgl-q3-earnings-revenues-121503762.html?.tsrc=rss&ref=bullished.co) — Yahoo Finance
- [Madrigal: Q3 Earnings Snapshot – WTOP News](https://wtop.com/national/2026/11/madrigal-q3-earnings-snapshot/?ref=bullished.co) — wtop.com
- [Madrigal PharmaceuticalsEPS of $1.83, revenue of $431.3M beats by $26.18M (MDGL:NASDAQ)](https://seekingalpha.com/news/4663282-madrigal-pharmaceuticalseps-of-183-revenue-of-4313m-beats-by-2618m?ref=bullished.co) — seekingalpha.com
- [S&P 500 Futures Decline in Premarket Trading; Ascendis Pharma, Madrigal Pharmaceuticals Lead](https://www.barrons.com/articles/s-p-500-futures-decline-in-premarket-trading-ascendis-pharma-madrigal-pharmaceuticals-lead-90680387?ref=bullished.co) — Barron's