Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
4,500 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for adults with a specific liver disease called MASLD. Participants will take either retatrutide, tirzepatide, or a placebo, and will have multiple visits over about 224 weeks to monitor their health and liver function.
Are You a Good Fit for This Trial?
You may be able to join if
I have liver fat content of 8% or more.
I have an ELF score between 9 and 10.8.
I have a VCTE LSM score between 10 and 20 kPa.
You may not be able to join if
I have another type of liver disease.
I have a body mass index (BMI) of less than 25 kg/m2.
I have a history of serious liver problems.
I have lost more than 11 pounds in the last 3 months.
I have a hemoglobin A1c greater than 10%.
I have type 1 diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 (…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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