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
- Amiens Cedex 1, Angers, Bobigny, Clichy, Creteil, Lille Cedex, Lyon Cedex 04, Nice, Paris, Pessac, St Herblain, Strasbourg Cedex, Vandoeuvre Les Nancy és Villejuif, FranciaországSee the 14 sites
- Phase
- 3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisBobigny, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisClichy, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisCreteil, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországToborzás még nem indult
- Hopital De La Croix-RousseLyon Cedex 04, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de NiceNice, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux de ParisParis, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországToborzás még nem indult
- Sante AtlantiqueSt Herblain, FranciaországToborzás még nem indult
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranciaországToborzás még nem indult
- CHRU De NancyVandoeuvre Les Nancy, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisVillejuif, FranciaországToborzás még nem indult
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 Research & Development Limited
- Trial code
- EU 2026-525755-82-00
- Record updated
- 2026. október 19.
- Original description
To determine the time to composite clinical outcome following treatment with efimosfermin compared to placebo.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)
To determine the time to composite clinical outcome following treatment with efimosfermin compared to placebo.
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).