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New treatment option 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)
ClinicalTrials.gov ID: NCT07165028
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatotic liver disease.
Also referred to as LY3298176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 224 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tuscaloosa, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Peoria, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- North Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Fountain Valley, California, United States
- Fresno, California, United States
- La Jolla, California, United States
- Lake Forest, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Riverside, California, United States
- San Diego, California, United States
+ 420 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 224 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscaloosa, Alabama, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Peoria, Arizona, United States; Sun City, Arizona, United States; Tucson, Arizona, United States and 434 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.