At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tirzepatide (drug), Retatrutide (drug), Placebo (drug)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- Tirzepatide — drug: Administered SC · Retatrutide — drug: Administered SC · Placebo — drug: Administered SC
- Patient visit burden
- "Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,500
- Started
- 2025-10-15
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metabolic dysfunction-associated steatotic liver disease
- • Phase3 - 4,500 participants
- • The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metabolic dysfunction-associated steatotic liver disease
Where?
- • Aberdeen - Aberdeen Royal Infirmary
- • Clifton - 4 Medical Solutions, Ltd - Manchester
- • Enfield - Panthera Biopartners - North London
- • Glasgow - Panthera Biopartners - Glasgow
- • +13 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗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, liver encephalopathy)
- ✗Have lost more than 11 pounds within the 3 months prior to screening
- ✗Have a red blood cell level A1c (HbA1c) greater than 10%
See the full criteria
Where Is This Study? (17 UK sites)
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
4 Medical Solutions, Ltd - Manchester
Clifton M27 8FF, United Kingdom
Panthera Biopartners - North London
Enfield EN3 4GS, United Kingdom
Panthera Biopartners - Glasgow
Glasgow G51 4RY, United Kingdom
Ipswich Hospital
Ipswich IP4 5PD, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool L9 7AL, United Kingdom
Royal London Hospital
London E1 1FR, United Kingdom
4 Medical Solutions, Ltd - London
London IG1 4HP, United Kingdom
Royal Free Hospital
London NW32QG, United Kingdom
King's College Hospital
London SE5 9RL, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
The John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Atlantic Medical
Penzance TR18 3DX, United Kingdom
Panthera Biopartners - Preston
Preston PR2 9QB, United Kingdom
Panthera Biopartners - Manchester
Rochdale OL11 4AU, United Kingdom
Panthera Biopartners - Sheffield
Sheffield S2 5FX, United Kingdom
Panthera Clinic - York
York YO24 4LJ, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT