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Not yet taking people in ItalyPhase 3

Tests efimosfermin against placebo in adults with cirrhosis from MASH

Tests efimosfermin versus placebo in adults with compensated cirrhosis from MASH.

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, 63 sites
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)
Status
Not yet recruiting
Phase
Phase 3
People taking part
382 people, planned
Started
6 Nov 2026
Expected to end
27 May 2034
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 aged 18 to 75 who have compensated cirrhosis (scarred liver that still works well enough) caused by MASH, and at least two parts of metabolic syndrome.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
Earlier treatment
Recent or planned weight-loss surgery or weight-loss medicines are not allowed.

Main reasons for not taking part

  • Other chronic liver diseases
  • Decompensated liver disease or liver cancer (hepatocellular carcinoma)
  • Type 1 diabetes or major Type 2 diabetes complications
  • 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 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

Who cannot take part

  • 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)

Where in Italy

Also in 9 other countries, 63 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 time to composite clinical outcome following treatment with efimosfermin compared to placebo.

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, 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)
Plain-language title
Tests efimosfermin against placebo in adults with cirrhosis from 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