NCT07701993 A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
| NCT ID | NCT07701993 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Condition | Metabolic Dysfunction-associated Steatohepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,740 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2033-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,740 participants in total. It began in 2026-07-22 with a primary completion date of 2033-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Eligibility Criteria
Inclusion Criteria: * Participants aged between 18 and 75 years at enrollment. * Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments. * Participants with history or presence of at least two components of metabolic syndrome. Exclusion Criteria: * Participants with other chronic liver diseases. * Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma. * Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications. * Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening. * Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss. * Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5 times upper limit normal (ULN). * Participants with current or history of excessive alcohol intake.
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT07701993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metabolic Dysfunction-associated Steatohepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07701993 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,740 participants.
Is NCT07701993 currently recruiting?
Yes, NCT07701993 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07701993 trial being conducted?
This trial is being conducted at Miami, United States, Miami, United States, Dallas, United States, Humble, United States and 2 additional locations.
Who is sponsoring the NCT07701993 clinical trial?
NCT07701993 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 1,740 participants.