2026-525755-82-00Not yet recruitingPhase 3
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)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Oct 2026
Brief summary (registry, in English)
To determine the time to composite clinical outcome following treatment with efimosfermin compared to placebo.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 382 (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
- 2026-525755-82-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 382
- 72 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 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
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
- 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.
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 complications
- Participants with current or history of excessive alcohol intake.
Lab values
- Participants with 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 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (72)
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 |
| Klinik Hietzing | 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 |
| Medical Centre Futuremeds EOOD | Plovdiv | Bulgaria | Not yet recruiting |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD | Sliven | Bulgaria | Not yet recruiting |
| Diagnostic Consultative Centre Ascendent EOOD | Sofia | Bulgaria | Not yet recruiting |
| University Hospital Lozenetz | Sofia | Bulgaria | Not yet recruiting |
| Multispecialty hospital for active treatment Sveta Sofia EOOD | Sofiya | Bulgaria | Not yet recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD | Sofiya | Bulgaria | Not yet recruiting |
| MBAL Trakia EOOD | Stara Zagora | Bulgaria | Not yet recruiting |
| Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH | Berlin | Germany | 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 |
| Micancer Center S.L.P. | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau | 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 |
| Hospital Universitario de la Princesa | 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 | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Clichy | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Creteil | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | 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 |
| 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 |
| Evangelismos S A | Athens | Greece | Not yet recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Not yet recruiting |
| Hippokration Hospital | Athens | Greece | Not yet recruiting |
| University General Hospital of Heraklion | Heraklion | Greece | Not yet recruiting |
| Hippokration Hospital | Thessaloniki | Greece | Not yet recruiting |
| University General Hospital of Thessaloniki - AHEPA | 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 Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon | 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.