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 (SYNERGY-Outcomes)
The primary objective of the study is to assess the reduction in risk of developing the following MALO events in participants with high-risk MASLD Progression to cirrhosis Development of large esophageal varices, gastric varices, or development of varices needing treatment Development of new onset ascites Development of hepatic encephalopathy Evidence of active or recent variceal hemorrhage Increase in Model for End-Stage Liver Disease score from 12 or lower to 15 or higher Liver transplantation, and All-cause mortality.
Why this Research Matters
This is a multicenter, randomized, parallel-arm, double-blind, placebo-controlled Phase 3 umbrella-type master protocol to evaluate the safety and efficacy of multiple pharmacologic agents (intervention) for the treatment of high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The overall protocol design comprises 2 components, which, when combined, define the investigations to be conducted in this master protocol (MP).
Who can Participate
Age and Informed Consent 1. Participants must be at least 18 years of age (or the legal age of consent according to local regulations) at the time of signing the ICF and are capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Type of participant and disease characteristics 2. ELF score of ≥9 and ≤10.8 at screening (Visit 1). 3. VCTE-LSM ≥10 kPa and <20 kPa at screening (2 scans are required to assess eligibility; eligibility is determined by the lower value of 2 LSM results obtained during screening). 4. Liver fat content ≥8% as determined by MRI-PDFF at Visit 2. Note: Participants must meet inclusion criteria #2 and #3 before proceeding to the MRI at Visit 2. Participants must meet MRI-PDFF criterion prior to inclusion in the study. Sex assigned at birth and contraceptive/barrier requirements 5. Assigned male at birth/assigned female at birth. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies For the contraception requirements of this protocol, see Section 10.4. Participants’ partners of childbearing potential must also use contraception during the study. Participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
Study ID
Protocol Number: 26-0239
More information available at ClinicalTrials.gov: NCT07165028
Meet the Team
Principal Investigator