GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

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

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

Lead sponsor

Eli Lilly and Company

Assets

Retatrutide / Tirzepatide

Listed sites

562

Recruiting sites

341

Enrollment

4,500

estimated

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•First Occurrence of Any Component of the Composite Endpoint for Major Adverse (Progression to cirrhosis, Hepatic-decompensation composite, liver transplantation, All-cause death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07165028

Org study ID27610

Secondary ID2025-522674-36-00

Secondary IDN1T-MC-MALOEli Lilly and Company

Secondary IDN1T-MC-RT01Eli Lilly and Company

Secondary IDN1T-MC-TZ01Eli Lilly and Company

Timeline

Milestones

Study first posted2025-09-10actual

Study start2025-10-15actual

Last update posted2026-05-22actual

Primary completion2030-08estimated (month precision)

Study completion2032-08estimated (month precision)

Assets

Investigational agents

Retatrutide Tirzepatide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Cardiovascular outcomes

Weight & body composition

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)

Time frame:Baseline up to Study Completion (about 224 weeks)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Study Completion (about 224 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

MASH / liver

8 endpoints

Primary/protocol endpoint

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)

time to event, event

componentsProgression to cirrhosis, Hepatic-decompensation composite, liver transplantation, All-cause death

Secondary/protocol endpoint

Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

Time frame:Baseline, Week 104

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)

Time frame:Baseline, Week 104

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Liver Fat Content (LFC)

Time frame:Baseline, Week 104

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

Time to Occurrence of Progression to Cirrhosis

Time frame:Baseline up to Study Completion (about 224 weeks)

Progression to cirrhosis

time to event, event

Secondary/protocol endpoint

Change from Baseline in Aspartate Aminotransferase (AST)

Time frame:Baseline, Study Completion (about 224 weeks)

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change from Baseline in Alanine Aminotransferase (ALT)

Time frame:Baseline, Study Completion (about 224 weeks)

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint/low confidence

Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK)

Time frame:Baseline, Week 104

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.