2026-525757-37-00Not yet recruitingPhase 3
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)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 6 Nov 2026
- Lead sponsor
- Glaxosmithkline Research & Development Limited
- Diseases
- Fatty liver disease (MASLD/MASH)
- EU CT number
- 2026-525757-37-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 69
- 67 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Not yet recruiting |
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg | Klagenfurt Am Woerthersee | Austria | Not yet recruiting |
| Medical University of Vienna | Vienna | Austria | Not yet recruiting |
| Hopital Erasme | Anderlecht | Belgium | Not yet recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Not yet recruiting |
| Universitair Ziekenhuis Gent | Gent | Belgium | Not yet recruiting |
| Az Maria Middelares Gent | Gent | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | Not yet recruiting |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Not yet recruiting |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. | Panagyurishte | Bulgaria | Not yet recruiting |
| University Hospital Lozenetz | Sofia | Bulgaria | Not yet recruiting |
| Diagnostic Consultative Centre Ascendent EOOD | Sofia | Bulgaria | Not yet recruiting |
| Multispecialty hospital for active treatment Sveta Sofia EOOD | Sofiya | Bulgaria | Not yet recruiting |
| MBAL Trakia EOOD | Stara Zagora | Bulgaria | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not yet recruiting |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Not yet recruiting |
| Universitaet Des Saarlandes | Homburg | Germany | Not yet recruiting |
| Eugastro GmbH | Leipzig | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Not yet recruiting |
| Universitaet Muenster | Muenster | Germany | Not yet recruiting |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not yet recruiting |
| Pratia Mcc Clinic Spain S.L. | Barcelona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Not yet recruiting |
| Hospital Universitario De Leon | León | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Not yet recruiting |
| Hospital General De Tomelloso | Tomelloso | Spain | Not yet recruiting |
| Consorcio Hospital General Universitario de Valencia | Valencia | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Not yet recruiting |
| Centre Hospitalier Universitaire D'Angers | Angers | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Bobigny Cedex | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Clichy | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Creteil Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Lille | Lille | France | Not yet recruiting |
| Hopital De La Croix-Rousse | Lyon Cedex 04 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 13 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Not yet recruiting |
| Sante Atlantique | St Herblain | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex | France | Not yet recruiting |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Villejuif | France | Not yet recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Not yet recruiting |
| Hippokration Hospital | Athens | Greece | Not yet recruiting |
| Evangelismos S A | Athens | Greece | Not yet recruiting |
| University General Hospital of Heraklion | Heraklion | Greece | Not yet recruiting |
| University General Hospital of Thessaloniki - AHEPA | Thessaloniki | Greece | Not yet recruiting |
| Hippokration Hospital | Thessaloniki | Greece | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Foggia | Italy | Not yet recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera di Padova | Padova | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
| Bernhoven B.V. | Uden | Netherlands | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Not yet recruiting |
| ID Clinic Arkadiusz Pisula | Myslowice | Poland | Not yet recruiting |
| Solumed Centrum Medyczne Sp. z o.o. | Poznan | Poland | Not yet recruiting |
| Medical Network Sp z o o | Warsaw | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.