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
- APPROVED
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
- APPROVED
Resmetirom is not approved in any geography for the treatment of patients with MASH cirrhosis.
Ervogastat/resmetirom combination1
Oral DGAT-2 inhibitor/oral THR-β agonist
POPULATION
MASH
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- APPROVED
MGL-2086/resmetirom combination2
Oral GLP-1 receptor agonist/oral THR-β agonist
POPULATION
MASH
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- APPROVED
MGL-0795/resmetirom combination3
siRNA PNPLA3/oral THR-β agonist
POPULATION
MASH
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- APPROVED
siRNA/resmetirom combination (six programs)
POPULATION
MASH
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- APPROVED
Additional MASH Assets
Three exploratory assets in varying stages of development
- Ervogastat Phase 2b trial completed by Pfizer. Resmetirom/ervogastat Phase 1 drug-drug interaction trial expected to initiate in 4Q26; Phase 2 combination trial expected to initiate in 2027 following regulatory discussions.
- MGL-2086 Phase 1 single ascending dose trial initiated in 2Q26.
- MGL-0795 (formerly ARO-PNPLA3) monotherapy Phase 1 trial completed by Arrowhead.
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)
MAESTRO-NAFLD-1 Safety Study
The first noninvasive Phase 3 study in MASLD (presumed MASH) (F1-F3)
MAESTRO-NASH-OUTCOMES Cirrhosis Study
An outcomes study in patients with well-compensated MASH cirrhosis (F4c)
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; February 11, 2026.