A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Purpose

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.

Condition

  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide (TZ01) 		Participants will receive tirzepatide subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo (TZ01) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC
Experimental
Retatrutide (RT01) 		Participants will receive retatrutide SC
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Placebo (RT01) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Ark Clinical Research - Fountain Valley
Fountain Valley 5350207, California 5332921 92708
Contact:
714-988-2021

Fresno Clinical Research Center
Fresno 5350937, California 5332921 93720
Contact:
559-970-3441

Ark Clinical Research
Long Beach 5367929, California 5332921 90815
Contact:
562-997-1000

K2 Medical Research - Daytona Beach
Daytona Beach 4152872, Florida 4155751 32114

Care Access - Delray Beach
Delray Beach 4153132, Florida 4155751 33484
Contact:
401-773-7855

Encore Borland-Groover Clinical Research
Jacksonville 4160021, Florida 4155751 32256
Contact:
904-680-0871

Health Awareness
Jupiter 4160610, Florida 4155751 33458

Florida Research Institute
Lakewood Rch 7255365, Florida 4155751 34211
Contact:
941-727-7772

Evolution Clinical Trials
Miami 4164138, Florida 4155751 33122-1722
Contact:
786-706-1216

Headlands Research Orlando
Orlando 4167147, Florida 4155751 32819
Contact:
407-705-3471

Progressive Medical Research
Port Orange 4169156, Florida 4155751 32127
Contact:
386-304-7070

Care Access - St. Petersburg
St. Petersburg 4171563, Florida 4155751 33710
Contact:
877-791-0656

Care Access - Tamarac
Tamarac 4174738, Florida 4155751 33321
Contact:
877-791-0656

Digestive Research Alliance of Michiana
South Bend 4926563, Indiana 4921868 46635
Contact:
574-904-9617

Care Access - New Iberia
New Iberia 4334971, Louisiana 4331987 70560
Contact:
813-851-0135

Lucida Clinical Trials
New Bedford 4945121, Massachusetts 6254926 02740

Great Lakes Research Institute
Southfield 5010636, Michigan 5001836 48075
Contact:
248-864-5242

Excel Clinical Research, LLC
Las Vegas 5506956, Nevada 5509151 89109
Contact:
702-680-1500

Clinical Research of Philadelphia
Pennington 5102535, New Jersey 5101760 08534
Contact:
215-676-6696

IMA Clinical Research Warren
Warren Township 8299577, New Jersey 5101760 07059

Care Access - Yonkers
Yonkers 5145215, New York 5128638 10701

Akron Gastro Research
Akron 5145476, Ohio 5165418 44320

IMA Clinical Research Austin
Austin 4671654, Texas 4736286 78745
Contact:
512-649-0082

Soma Clinical Trials
Denison 4685892, Texas 4736286 75020
Contact:
469-819-0228

Care Access - Houston
Houston 4699066, Texas 4736286 77054
Contact:
877-791-0656

Biopharma Informatic, LLC
Houston 4699066, Texas 4736286 77084
Contact:
281-944-3610

Clinical Trials of Texas, LLC dba Flourish Research
San Antonio 4726206, Texas 4736286 78229
Contact:
210-949-0122

IMA Clinical Research San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
210-692-7157

Consano Clinical Research, LLC
Shavano Park 4728147, Texas 4736286 78231
Contact:
210-545-4900

Medrasa Clinical Research
Wylie 4743275, Texas 4736286 75098
Contact:
469-449-3645

Care Access - Ogden
Ogden 5779206, Utah 5549030 84403
Contact:
801-614-0010

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com