NCT07221188RecruitingPhase 3
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1250 (estimated)
- First submitted
- 15 Oct 2025
- Start date
- 12 Dec 2025
- Primary completion date
- 24 Mar 2028
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07221188
- EU CT number
- 2025-523674-16-00
- EudraCT number
- 2025-523674-16
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1250
- From 12 Dec 2025 to the primary completion date, 24 Mar 2028
- 154 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
- Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening
Other illness
- Model for End-Stage Liver Disease (MELD) 3.0 score \>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
- Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.
Lab values
- ALT or AST \>=5 × upper limit of normal (ULN)
- Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
- Serum albumin \<=3.5 grams per deciliter (g/dL)
- International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
- Alkaline phosphatase (ALP) \>=2 × ULN
- Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
- Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
- HbA1c \>=9.0%
Other
- Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
- Phosphatidylethanol (PEth) \>=80 nanogram per milliliter (ng/mL) at Screening
Who the study is looking for
- Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
- Age \>=18 through \<=75 years at enrolment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- History or presence of known or suspected MASH with evidence of fibrosis
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (154)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg Coordinator of this site? Confirm its status | Klagenfurt Am Woerthersee | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Coordinator of this site? Confirm its status | Gorna Oryahovitsa | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Coordinator of this site? Confirm its status | Panagyurishte | Bulgaria | Recruiting |
| Medical Centre Futuremeds EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Coordinator of this site? Confirm its status | Sliven | Bulgaria | Recruiting |
| Diagnostic Consultative Centre Ascendent EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Hospital Lozenetz Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Multispecialty hospital for active treatment Sveta Sofia EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| MBAL Trakia EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Eugastro GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Recruiting |
| Hospital Quirónsalud Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Micancer Center S.L.P. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Policlinica Gipuzkoa S.A. Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital General De Tomelloso Coordinator of this site? Confirm its status | Tomelloso | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Regional D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Hopital De La Croix-Rousse Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Sante Atlantique Coordinator of this site? Confirm its status | St Herblain | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif Cedex | France | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pokfulam | Hong Kong SAR China | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Gunma | Japan | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Bernhoven B.V. Coordinator of this site? Confirm its status | Uden | Netherlands | Not yet recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Wellington | New Zealand | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Amicare Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| ID Clinic Arkadiusz Pisula Coordinator of this site? Confirm its status | Myslowice | Poland | Recruiting |
| Solumed Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Melita Medical Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Arcadia | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Boynton Beach | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Brownsville | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cape Coral | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Clermont | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Covina | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | East Syracuse | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Homestead | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Inverness | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Jersey City | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kissimmee | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Lakeland | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Manassas | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Marrero | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Morehead City | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Palmetto Bay | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Santa Maria | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seabrook | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Springboro | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Van Nuys | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Waco | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | West Jordan | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.