Tests efimosfermin against placebo in adults with cirrhosis from MASH
Tests efimosfermin alfa against placebo in adults with cirrhosis caused by MASH.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Arlington, Austin, Bellaire, Cape Coral, Dallas, Folsom, Fort Myers, Hialeah, Homestead, Humble, Kissimmee, Lakeland, Little Rock, Manassas, Miami, Morehead City, New York, Ocala, San Antonio, Santa Maria, St Louis, University Park, Waco, West Jordan, and Westlake, United StatesSee the 25 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07701993, who can take part
Where in United States
- ArlingtonArlington, United StatesTaking people
- AustinAustin, United StatesTaking people
- BellaireBellaire, United StatesTaking people
- Cape CoralCape Coral, United StatesTaking people
- DallasDallas, United StatesTaking people
- FolsomFolsom, United StatesTaking people
- Fort MyersFort Myers, United StatesTaking people
- HialeahHialeah, United StatesTaking people
- HomesteadHomestead, United StatesTaking people
- HumbleHumble, United StatesTaking people
- KissimmeeKissimmee, United StatesTaking people
- LakelandLakeland, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- ManassasManassas, United StatesTaking people
- MiamiMiami, United StatesTaking people
- Morehead CityMorehead City, United StatesTaking people
- New YorkNew York, United StatesTaking people
- OcalaOcala, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- Santa MariaSanta Maria, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- University ParkUniversity Park, United StatesTaking people
- WacoWaco, United StatesTaking people
- West JordanWest Jordan, United StatesTaking people
- WestlakeWestlake, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07701993
- Record updated
- 5 November 2026
- Original description
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.Read full original descriptionShow less
A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Inclusion: 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: 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 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 current or history of excessive alcohol intake; Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=5 times upper limit normal (ULN).