A study to investigate safety and efficacy of efimosfermin compared with placebo in adult participants with compensated cirrhosis (stage F4 fibrosis) due to MASH (NEBULA-2)
Key facts
- Where
- Amiens Cedex 1, Angers, Bobigny Cedex, Clichy, Creteil Cedex, Lille, Lyon Cedex 04, Nice, Paris, Paris Cedex 13, Pessac, St Herblain, Strasbourg Cedex, Vandoeuvre Les Nancy és Villejuif, FranciaországSee the 15 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 Cedex, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisClichy, FranciaországToborzás még nem indult
- Assistance Publique Hopitaux De ParisCreteil Cedex, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de LilleLille, 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
- Assistance Publique Hopitaux De ParisParis Cedex 13, 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 2026-525757-37-00
- Record updated
- 2026. október 19.
- Original description
To determine the effect of efimosfermin compared to placebo on fibrosis improvement of greater than or equal to (>=) 1 stage and no worsening of MASHRead full original descriptionShow less
A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)
To determine the effect of efimosfermin compared to placebo on fibrosis improvement of greater than or equal to (>=) 1 stage and no worsening of MASH
Inclusion: Participants aged between 18 and 75 years at enrolment; Participants with history or presence of at least two components of metabolic syndrome; Liver biopsy consistent with cirrhosis (fibrosis stage 4).
Exclusion: History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening; 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 mellitus complications; Current or history of excessive alcohol intake; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).