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A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (N1T-MC-MALO N1T-MC-TZ01 N1T-MC-RT01)

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) (N1T-MC-MALO N1T-MC-TZ01 N1T-MC-RT01)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

Nov. 27, 2025

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

- Have liver fat content >=8%
- Have ELF score of >=9 and <=10.8 at screening
- Have VCTE LSM >=10 kilopascal (kPa) and <20 kPa at screening

- Have any other type of liver disease other than MASLD
- Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)
- Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
- Have lost more than 11 pounds within the 3 months prior to screening
- Have a hemoglobin A1c (HbA1c) greater than 10%
- Have type 1 diabetes

Both

Metabolic Dysfunction-Associated Steatotic Liver Disease

DRUG: Tirzepatide(Other Name: LY3298176)
Administered SC
DRUG: Retatrutide(Other Name: LY3437943)
Administered SC
DRUG: Placebo
Administered SC

(Study Arms)
Experimental: Tirzepatide (TZ01)
Participants will receive tirzepatide subcutaneously (SC)
Interventions:
Drug: Tirzepatide
Placebo Comparator: Placebo (TZ01)
Participants will receive placebo SC
Interventions:
Drug: Placebo
Experimental: Retatrutide (RT01)
Participants will receive retatrutide SC
Interventions:
Drug: Retatrutide
Placebo Comparator: Placebo (RT01)
Participants will receive placebo SC
Interventions:
Drug: Placebo

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) [ Time Frame: Baseline up to Study Completion (about 224 weeks)
Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from <=12 to >=15, liver transplantation, all-cause mortality

+81-23-633-1122

Nov. 04, 2025

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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