Tirzepatide + Retatrutide for Fatty Liver Disease

Recruiting at 531 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Other liver disease, BMI <25, Decompensated liver, Weight loss, HbA1c >10%, Type 1 diabetes

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 25

Duration: 224 weeks

4500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD) are eligible for this trial. They must have a likelihood of developing major adverse liver outcomes as indicated by non-invasive tests. Key exclusions include other significant medical conditions, participation in other studies, or factors that may interfere with the study.

Inclusion Criteria

Have ELF score of ≥9 and ≤10.8 at screening

Have VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening

My liver fat content is 8% or higher.

Exclusion Criteria

Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)

Have a hemoglobin A1c (HbA1c) greater than 10%

I do not have any liver disease other than MASLD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either retatrutide, tirzepatide, or placebo to assess prevention of major adverse liver outcomes

224 weeks

25 to 30 clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Eligible participants may continue to receive retatrutide or tirzepatide for an additional 2 years

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Retatrutide
• Tirzepatide

Trial Overview The SYNERGY-OUTCOMES trial is testing whether retatrutide and tirzepatide can prevent serious liver problems in people with MASLD. Participants will be randomly assigned to receive either one of these drugs or a placebo over approximately 224 weeks, involving up to 30 clinic visits.

How Is the Trial Designed?

Group I: Tirzepatide (TZ01) Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC)

Group II: Retatrutide (RT01) Experimental Treatment 1 Intervention

Participants will receive retatrutide SC

Group III: Placebo (RT01) Placebo Group 1 Intervention

Participants will receive placebo SC

Group IV: Placebo (TZ01) Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University