A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
{ "SYNERGY-Outcomes Study for Metabolic Dysfunction-Associated Steatotic Liver Disease", "This study, called SYNERGY-Outcomes, is looking into whether two medications, tirzepatide and retatrutide, can prevent serious liver problems (Major Adverse Liver Outcomes or MALO) in adults with a high risk of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). MASLD is a condition where too much fat builds up in the liver. You might be able to join if you are an adult with MASLD and specific non-invasive test results showing certain levels of liver fat and stiffness. Participants will be randomly assigned to receive either tirzepatide, retatrutide, or a placebo (an inactive substance) through injections under the skin. The study aims to enroll about 4,500 adults and will last for approximately 224 weeks, with the main goal being to see if these medications can prevent MALO.", "design": "This is an interventional study that plans to enroll about 4,500 adult participants. Participants will be randomly assigned to receive one of two active drugs or a placebo.", "commitments": "You may have up to approximately 25 to 30 clinic visits over about 224 weeks to monitor your health, complete study procedures, and assess liver function.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed from Baseline up to study completion, which is about 224 weeks, to track the first occurrence of any major adverse liver outcome.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
At a glance
Conditions
NCT07165028
Where you'd take part
This study runs at 563 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
4 Medical Solutions, Ltd - London
London, United Kingdomstudy coordinator listed
Recruiting
4 Medical Solutions, Ltd - Manchester
Clifton, United Kingdomstudy coordinator listed
Recruiting
A.O.U. Policlinico Paolo Giaccone
Palermo, Italystudy coordinator listed
Recruiting
Abe Clinic
Ōita, Japanstudy coordinator listed
Recruiting
Aberdeen Royal Infirmary
Aberdeen, United Kingdomstudy coordinator listed
Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Turkey (Türkiye)study coordinator listed
Not yet recruiting
Advanced Research Institute - Sandy
Sandy City, Utahstudy coordinator listed
Recruiting
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Chinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)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