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Taking people in United StatesPhase 3

Tests efimosfermin against placebo in adults with cirrhosis from MASH

Tests efimosfermin alfa against placebo in adults with cirrhosis caused by MASH.

Key facts

Who runs it
GlaxoSmithKline
Where
Arlington, Austin, Bellaire, Cape Coral, Dallas, Folsom, Fort Myers, Hialeah, Homestead, Humble, Kissimmee, Lakeland, Little Rock, Manassas, Miami, Morehead City, New York, Ocala, San Antonio, Santa Maria, St Louis, University Park, Waco, West Jordan, and Westlake, United StatesSee the 25 sitesAlso in 1 other country, 2 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
Recruiting
Phase
Phase 3
People taking part
1,740 people, planned
Started
22 Jul 2026
Expected to end
24 Aug 2033
Type of study
Interventional, 2 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 (scarred liver that still works) caused by MASH, a fatty liver disease linked to metabolic problems.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Compensated cirrhosis due to MASH, confirmed by non-invasive tests. At least two components of metabolic syndrome, now or in the past.
Earlier treatment
People with a recent or planned surgery or medicine meant to cause significant weight loss cannot join.
Biomarker or test result
ALT or AST of 5 times the upper limit of normal or more rules a person out.

Main reasons for not taking part

  • Other chronic liver diseases
  • Decompensated liver disease or liver cancer (hepatocellular carcinoma), now or in the past
  • 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 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)

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

  • Arlington, TexasHospital not named in the registryContact: Reem Ghalib (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
  • 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
  • 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
  • Santa Maria, CaliforniaHospital not named in the registryContact: Keval Shah (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
  • 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 study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

The 2 groups in the trial

  • Participants receiving efimosfermin alfaTreatment being tested

    Treatment: Efimosfermin alfa

  • Participants receiving placeboPlacebo, for comparison

    Treatment: 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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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 12 November 2026.
Fit questions
Built from NCT07701993, who can take part
Record updated
5 November 2026