Shaping the Future of MASH Care

Our pipeline is anchored in advancing therapies for metabolic dysfunction-associated steatohepatitis (MASH), guided by our expertise in liver care and commitment
to patients.

Our Pipeline

Resmetirom

Oral THR-β agonist

POPULATION

MASH F2-F3

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

This indication is approved under accelerated (conditional) approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

POPULATION

MASH F4c

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

Resmetirom is not approved in any geography for the treatment of patients with cirrhosis.

Ervogastat/resmetirom combination1

Oral DGAT-2 inhibitor/oral THR-β agonist

POPULATION

MASH

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

ARO-PNPLA3/resmetirom combination2

siRNA/oral THR-β agonist

POPULATION

MASH

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

MGL-2086/resmetirom combination3

Oral GLP-1 receptor agonist/oral THR-β agonist

POPULATION

MASH

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

siRNA/resmetirom combination (six programs)

POPULATION

MASH

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

Additional MASH Assets

Three exploratory assets in varying stages of development

  1. Ervogastat monotherapy Phase 2b trial completed by Pfizer; drug-drug (resmetirom/ervogastat) interaction (DDI) trial expected to initiate in 4Q26; Phase 2 combination trial expected to initiate in 2027.
  2. ARO-PNPLA3 monotherapy Phase 1 trial completed by Arrowhead.
  3. MGL-2086 Phase 1 single ascending dose (SAD) trial expected to initiate in 2Q26.

Our Resmetirom Clinical Development Program

Madrigal has established the leading clinical development program in MASH, including multiple Phase 3 clinical trials:

Pivotal MAESTRO-

NASH Study

Patients with noncirrhotic MASH with moderate to advanced fibrosis (F2-F3)

Learn More

MAESTRO-NAFLD-1 
Safety Study

The first noninvasive Phase 3 study in MASLD (presumed MASH) (F1-F3)

Learn More

MAESTRO-NASH-OUTCOMES Cirrhosis Study

An outcomes study in patients with well-compensated MASH cirrhosis (F4c)

Learn More
References

Harrison SA, Ratziu V, Anstee QM, et al. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024;59(1):51-63. 

Madrigal press release. Madrigal Expands its MASH Pipeline with Exclusive Global Licensing Agreement for Six Preclinical siRNA Programs; 2026.