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Taking people in United StatesPhase 3

Testing efimosfermin against placebo in adults with cirrhosis from MASH

Tests efimosfermin, compared with placebo, in adults with cirrhosis caused by MASH.

Key facts

Who runs it
GlaxoSmithKline
Where
Arcadia, Arlington, Arroyo Grande, Austin, Bellaire, Cape Coral, Dallas, East Syracuse, Folsom, Fort Myers, Hialeah, Homestead, Houston, Humble, Kissimmee, Lakeland, Little Rock, Manassas, Miami, Morehead City, New York, Ocala, San Antonio, Springboro, St Louis, University Park, Van Nuys, Waco, West Jordan, and Westlake, United StatesSee the 30 sitesAlso in 1 other country, 2 sites
Registry title
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Status
Recruiting
Phase
Phase 3
People taking part
380 people, planned
Started
22 Jul 2026
Expected to end
8 Dec 2033
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Efimosfermin alfa
  • Placebo
Record updated
5 November 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. It compares efimosfermin alfa with placebo.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Compensated cirrhosis (fibrosis stage 4) due to MASH, shown by liver biopsy.
Earlier treatment
Cannot have recent 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.

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 pancreas disease, or pancreatic injury or acute pancreatitis within 6 months before screening
  • ALT or AST 5 or more times the upper limit of normal

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)

Check if you might fit

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?

Where in United States

Also in 1 other country, 2 sites

  • Arcadia, CaliforniaHospital not named in the registryContact: Elias Tarakji (principal investigator)Taking people
  • Arlington, TexasHospital not named in the registryContact: Reem Ghalib (principal investigator)Taking people
  • Arroyo Grande, CaliforniaHospital not named in the registryContact: Keval Shah (principal investigator)Taking people
  • Austin, TexasHospital not named in the registryContact: Nomita Kim (principal investigator)Taking people
  • Bellaire, TexasHospital not named in the registryContact: Everald Manning (principal investigator)Taking people
  • Cape Coral, FloridaHospital not named in the registryContact: Paige Kreegel (principal investigator)Taking people
  • Dallas, TexasHospital not named in the registryContact: Valentine Ebuh (principal investigator)Taking people
  • East Syracuse, New YorkHospital not named in the registryContact: Rachel Dubroff (principal investigator)Taking people
  • Folsom, CaliforniaHospital not named in the registryContact: Nazir Rahim (principal investigator)Taking people
  • Fort Myers, FloridaHospital not named in the registryContact: Charles Smith (principal investigator)Taking people
  • Hialeah, FloridaHospital not named in the registryContact: Isaac Bassan (principal investigator)Taking people
  • Homestead, FloridaHospital not named in the registryContact: Gilberto Seco (principal investigator)Taking people
  • Houston, TexasHospital not named in the registryContact: Joe Pouzar (principal investigator)Taking people
  • Humble, TexasHospital not named in the registryContact: Brian Chou (principal investigator)Taking people
  • Kissimmee, FloridaHospital not named in the registryContact: Max Sosa Pagan (principal investigator)Taking people
  • Lakeland, FloridaHospital not named in the registryContact: James Andersen (principal investigator)Taking people
  • Little Rock, ArkansasHospital not named in the registryContact: John Baber (principal investigator)Taking people
  • Manassas, VirginiaHospital not named in the registryContact: Nabil Andrawis (principal investigator)Taking people
  • Miami, FloridaHospital not named in the registryContact: Yaneicy Gonzalez Rojas (principal investigator)Taking people
  • Morehead City, North CarolinaHospital not named in the registryContact: Kathryn Lucas (principal investigator)Taking people
  • New YorkHospital not named in the registryContact: Eli Shalenberg (principal investigator)Taking people
  • Ocala, FloridaHospital not named in the registryContact: Robert Barish (principal investigator)Taking people
  • San Antonio, TexasHospital not named in the registryContact: Robert Morin Jr (principal investigator)Taking people
  • Springboro, OhioHospital not named in the registryContact: Anjali Morey (principal investigator)Taking people
  • St Louis, MissouriHospital not named in the registryContact: Brian Mcmorrow (principal investigator)Taking people
  • University Park, FloridaHospital not named in the registryContact: Guy Neff (principal investigator)Taking people
  • Van Nuys, CaliforniaHospital not named in the registryContact: Robert Jenders (principal investigator)Taking people
  • Waco, TexasHospital not named in the registryContact: Gregg Lucksinger (principal investigator)Taking people
  • West Jordan, UtahHospital not named in the registryContact: Barbara Rizzardi (principal investigator)Taking people
  • Westlake, OhioHospital not named in the registryContact: Naim Alkhouri (principal investigator)Taking people

About the trial

What the trial wants to find out

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

The 3 groups in the trial

  • Part A: Participants receiving Efimosfermin alfaTreatment being tested

    Participants will receive efimosfermin alfa in Part A of the study.

    Treatment: Efimosfermin alfa

  • Part A: Participants receiving PlaceboPlacebo, for comparison

    Participants will receive placebo in Part A of the study.

    Treatment: Placebo

  • Part B: Participants receiving Efimosfermin alfaTreatment being tested

    All participants will receive efimosfermin alfa in Part B of the study.

    Treatment: Efimosfermin alfa

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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Testing 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 13 November 2026.
Fit questions
Built from NCT07704892, who can take part
Record updated
5 November 2026