A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510626-89-00

Acronym

MGL-3196-11

Enrollment

444

Registered

2024-04-22

Start date

2019-11-18

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Brief summary

Week 52 Dual Primary endpoints: NASH Resolution Response at Week 52 Fibrosis ≥ 1 Stage Responder at Week 52, Time to Composite Clinical Outcome Event at Month 54

Detailed description

Percent change from baseline in directly measured LDL-C at Week 24 and Week 52

Interventions

DRUGMatching placebo MGL-3196 60 mg film-coated tablet

DRUGMatching placebo MGL-3196 80 mg film-coated tablet

DRUGMatching placebo MGL-3196 100 mg film-coated tablet.

DRUGMGL-3196 60 mg oral

DRUGMGL-3196 100 mg oral

DRUGMGL-3196 80 mg oral

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Week 52 Dual Primary endpoints: NASH Resolution Response at Week 52 Fibrosis ≥ 1 Stage Responder at Week 52, Time to Composite Clinical Outcome Event at Month 54	—

Secondary

Measure	Time frame
Percent change from baseline in directly measured LDL-C at Week 24 and Week 52	—

Countries

Austria, Belgium, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026