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Tests efimosfermin against placebo in adults with cirrhosis caused by MASH

Tests efimosfermin, compared with a placebo, in adults with MASH-related cirrhosis.

Key facts

Who runs it
Glaxosmithkline Research & Development Limited
Where
Bergamo, Bologna, Foggia, Milan, Padova, Rome, and Rozzano, ItalySee the 9 sitesAlso in 9 other countries, 58 sites
Registry title
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)
Status
Not yet recruiting
Phase
Phase 3
People taking part
69 people, planned
Started
6 Nov 2026
Expected to end
26 Feb 2033
Type of study
Interventional
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with compensated cirrhosis (stage 4 fibrosis) caused by MASH, a fatty liver disease linked to metabolic problems.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Liver biopsy consistent with cirrhosis (fibrosis stage 4) due to MASH. The cirrhosis must be compensated.
Earlier treatment
Cannot have recent or planned surgery or medicines meant to cause major weight loss.
Biomarker or test result
At least two components of metabolic syndrome, now or in the past. ALT or AST must be below 5 times the upper limit of normal.

Main reasons for not taking part

  • Other chronic liver diseases
  • Decompensated liver disease or liver cancer (hepatocellular carcinoma)
  • Type 1 diabetes, or major complications of Type 2 diabetes
  • Chronic pancreatic disease, or pancreatic injury or acute pancreatitis within 6 months before Screening
  • Current or past excessive alcohol intake

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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)

Where in Italy

Also in 9 other countries, 58 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
  • Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyNot yet recruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNot yet recruiting
  • Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
  • Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
  • Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyNot yet recruiting
  • Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests efimosfermin against placebo in adults with cirrhosis caused by MASHGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
19 October 2026