Phase 3 · NCT07165028
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
What this means
The registry describes the study design and status. This label does not mean results have been reported.
Figure / record sourceLast verified 23 Oct 2026
Registry record
Trial details
- Trial
- A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
- ClinicalTrials.gov ID
- NCT07165028
- Indication
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment
- 4,500
- Status
- Recruiting
- Interventions
- Drug: Tirzepatide; Drug: Retatrutide; Drug: Placebo
- Comparator
- Placebo
- Eligible ages
- 18 Years – No maximum
- Locations
- 563 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
- Study start
- 15 Oct 2025
- Primary completion
- 1 Aug 2030
- Study completion
- 1 Aug 2032
Verification
- Last verified
- 23 Oct 2026
- Source
- ClinicalTrials.gov
- Registry last updated
- 8 Oct 2026
Endpoints
Primary
Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
Secondary
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score; Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM); Percent Change from Baseline in Liver Fat Content (LFC); Time to Occurrence of Progression to Cirrhosis; Change from Baseline in Aspartate Aminotransferase (AST); Change from Baseline in Alanine Aminotransferase (ALT); Change from Baseline in Body Weight; Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK); Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)
Registry monitoring
Latest Trial Changes
| Field | Change | Detected | Source |
|---|---|---|---|
| Locations | 565 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States→563 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States | 9 Sept 2026 | ClinicalTrials.gov |