Testing Tirzepatide against a placebo for metabolic dysfunction-associated steatotic liver disease
Official title: 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
- Phase 3
- 4 groups
- Sites in Calgary, Chicoutimi and 9 more cities
- Recruiting
Interventions
- Medication
Tirzepatide
Administered SC
- Medication
Retatrutide
Administered SC
- Medication
Placebo
Administered SC
Canadian Sites (15)
6 of 15 recruiting
- Recruiting
Ecogene-21
Chicoutimi
- Recruiting
Wells Research Group
Edmonton
- Recruiting
Private Practice - Dr. Stephane M. Gauthier
North Bay
- Recruiting
Diex Recherche Quebec
Québec
- Recruiting
Clinical Research of Ontario
Toronto
- Recruiting
Diex Recherche Inc. Division Trois-Rivieres
Trois-Rivières
- Not yet recruiting
Heritage Medical Research Clinic
Calgary
- Not yet recruiting
University Of Alberta Hospital
Edmonton
- Not yet recruiting
QEII Health Sciences Centre - Victoria General Site
Halifax
- Not yet recruiting
University Hospital - London Health Sciences Centre
London
- Not yet recruiting
Toronto General Hospital
Toronto
- Not yet recruiting
St. Joseph's Health Centre
Toronto
- Not yet recruiting
Vancouver General Hospital
Vancouver
- Not yet recruiting
(G.I.R.I.) GI Research Institute Foundation
Vancouver
- Not yet recruiting
Health Sciences Centre Winnipeg
Winnipeg
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Have liver fat content ≥8%
- +Have ELF score of ≥9 and ≤10.8 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Have VCTE LSM ≥10 kilopascal (kPa) and \<20 kPa at screening
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Have a hemoglobin A1c (HbA1c) greater than 10%
- −Have type 1 diabetes
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives Tirzepatide.
Registry label: A: Tirzepatide (TZ01)
Groups B and D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: B: Placebo (TZ01) · D: Placebo (RT01)
Group C receives Retatrutide.
Registry label: C: Retatrutide (RT01)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,500 people.
The study is currently expected to finish around August 2032.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Study Completion (about 224 weeks).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to First Occurrence of Any Component of the Composite EndpointEndpointThe specific thing a study measures to answer its question.Read more → for Major Adverse Liver Outcomes (MALO) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Study Completion (about 224 weeks).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07165028 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TirzepatideDrug
Administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RetatrutideDrug
Administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Study Completion (about 224 weeks).
The study as a whole is currently expected to finish around 2032-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 21 locations, including: Calgary, Canada; Chicoutimi, Canada; Edmonton, Canada; Halifax, Canada; London, Canada; North Bay, Canada, and 15 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (12)
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States
Great Lakes Research Institute
Southfield, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
MNGI Digestive Health
Minneapolis, Minnesota, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
IMA Clinical Research Manhattan
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access - Yonkers
Yonkers, New York, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, United States
UW Medicine Diabetes Institute
Seattle, Washington, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.