Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
NCT ID: NCT06409130
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
270 participants
INTERVENTIONAL
2024-05-20
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NNC0194-0499 + semaglutide
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
NNC0194-0499
Administered subcutaneously.
Semaglutide
Administered subcutaneously.
NNC0194-0499 + semaglutide placebo
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
NNC0194-0499
Administered subcutaneously.
Semaglutide placebo (Group A)
Administered subcutaneously.
NNC0194-0499 placebo + semaglutide
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
Semaglutide
Administered subcutaneously.
NNC0194-0499 placebo
Administered subcutaneously.
NNC0194-0499 placebo + semaglutide placebo
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
NNC0194-0499 placebo
Administered subcutaneously.
Semaglutide placebo (Group A)
Administered subcutaneously.
CagriSema
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
Cagrilintide + semaglutide
Administered subcutaneously.
Cagrilintide + semaglutide placebo
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
Cagrilintide
Administered subcutaneously.
Semaglutide placebo (Group B)
Administered subcutaneously.
Cagrilintide placebo + semaglutide placebo
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.
Cagrilintide placebo
Administered subcutaneously.
Semaglutide placebo (Group B)
Administered subcutaneously.
Interventions
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NNC0194-0499
Administered subcutaneously.
Semaglutide
Administered subcutaneously.
NNC0194-0499 placebo
Administered subcutaneously.
Semaglutide placebo (Group A)
Administered subcutaneously.
Cagrilintide + semaglutide
Administered subcutaneously.
Cagrilintide
Administered subcutaneously.
Cagrilintide placebo
Administered subcutaneously.
Semaglutide placebo (Group B)
Administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent.
* Patient-reported history of alcohol overuse for greater than or equal to 5 years with an alcohol history of a mean of greater than or equal to 50 grams (male)/40 grams (female) pr day for the last year leading up to the time of signing informed consent.
* Enhanced Liver Fibrosis (ELF) greater than or equal to 9.0 units.
Exclusion Criteria
* Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD).
* Positive hepatitis B surface antigen (HBsAg), positive human immunodeficiency virus-1 (HIV-1) or HIV-2 antibody (Ab), positive hepatitis C virus (HCV) ribonucleic acid (RNA) at screening (V1) or any known presence of HCV RNA or HBsAg within 2 years of screening visit 1 (V1).
* Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at screening (V1).
* Alcohol hepatitis at randomisation (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA)).
* Vibration Controlled Transient Elastography liver stiffness measurement (LSM) greater than or equal to 25 kPa at visit 2 (V2). If participants meet this criterion, rescreening is allowed once.
* Presence or history of gastro-oesophageal varices greater than or equal to grade 2\* at V2. For participants with LSM greater than or equal to 20 kPa as well as blood platelets count less than 150,000 per microliter (μL) of blood an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must be available at V2. \*Grade 2: varices projecting by one-third of the luminal diameter that cannot be compressed with air insufflation4.
* Body mass index (BMI) less than or equal to 25 Kilogram Per Square Meter (kg/m\^2).
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method with low user-dependency.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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The Institute for Liver Health
Chandler, Arizona, United States
Arizona Liver Center
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
OM Research LLC
Lancaster, California, United States
California Liver Research Institute
Pasadena, California, United States
Covenant Metabolic Specialists LLC
Fort Myers, Florida, United States
Miguel Rebollar PA
Hialeah, Florida, United States
UF Hlth Jacksonville
Jacksonville, Florida, United States
Univ of Miami/Schiff Ctr
Miami, Florida, United States
Covenant Metabolic Specialists LLC
University Park, Florida, United States
Rush University Med. Cntr
Chicago, Illinois, United States
Kansas Medical Clinic, PA
Topeka, Kansas, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Boston Medical Center_Cary
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
DSI Research,LLC
Springboro, Ohio, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
UPMC_Center for Liver Care
Pittsburgh, Pennsylvania, United States
Digestive Health Research, TN
Hermitage, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
The Liver Institute
Dallas, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Research Institute
Houston, Texas, United States
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Liver Specialists of Texas
Sugar Land, Texas, United States
Velocity Clinical Res, Waco
Waco, Texas, United States
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Eastern Clinical Research Unit Box Hill
Box Hill, Victoria, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Fiona Stanley Hospital - Hepatology
Murdoch, Western Australia, Australia
MHAT St. Ivan Rilski Gorna Oriahovitsa EOOD
Gorna Oryahovitsa, , Bulgaria
Acibadem City Clinic UMHAT Tokuda EAD, Gastroenterology
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology
Sofia, , Bulgaria
UMHAT Aleksandrovska
Sofia, , Bulgaria
"DCC XX - Sofia" EOOD
Sofia, , Bulgaria
Medical Center Synexus Sofia EOOD
Sofia, , Bulgaria
University of Calgary Liver Unit-(HMRC)
Calgary, Alberta, Canada
GI Research Inst Foundation
Vancouver, British Columbia, Canada
London Health Sciences Centre- University Hospital
London, Ontario, Canada
TDDA Specialty Research
Vaughan, Ontario, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Krajská nemocice Liberec, a.s
Liberec, , Czechia
Vseobecna Fakultni nemocnice v Praze
Prague, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Herlev Hospital - Gastroenterology and Hepatology, Clinic 3
Herlev, , Denmark
Hvidovre Hospital - Gastroenheden
Hvidovre, , Denmark
Odense University Hospital - FLASH - Centre for Liver Research
Odense C, , Denmark
Centre Hospitalier Universitaire D'Angers-1
Angers, , France
Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
Lille, , France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, , France
Universitätsklinikum des Saarlandes - Innere Med. II
Homburg, , Germany
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, , Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, , Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, , Germany
Universitätsmedizin der JGU Mainz - Hepatologie
Mainz, , Germany
Universitätsklinikum Münster - Medizinische Klinik B
Münster, , Germany
Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)
Würzburg, , Germany
University Hospital of Athens ATTIKON
Athens, Attica, Greece
"Laiko" General Hospital of Athens
Goudi/Athens, , Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, , Greece
AOU Careggi Firenze
Florence, Tuscany, Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Fondazione Evangelica Betania - UO Epatologia
Naples, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Roma, , Italy
Juntendo University Hospital, Gastroenterology
Bunkyo-ku, Tokyo, , Japan
Juntendo University Hospital_Gastroenterology
Bunkyo-ku, Tokyo, , Japan
Akaicho Clinic
Chiba-shi, Chiba, , Japan
Ogaki Municipal Hospital_Gastroenterology and Hepatology
Gifu, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Ishikawa Prefectural Central Hospital_Gastroenterology
Kanazawa-shi, Ishikawa, , Japan
Kumamoto Shinto General Hospital_Liver・Gastroenterology
Kumamoto-shi, Kumamoto, , Japan
Toranomon Hospital, Hepatology
Minato-ku, Tokyo, , Japan
Heartlife Hospital_Liver internal medicine
Nakagamigun, Okinawa, , Japan
Oita Cardiovascular Hospital_Gastroenterology
Oita-shi, Oita, , Japan
JCHO Hokkaido Hospital_Digestive Disease Center
Sapporo-shi, Hokkaido, , Japan
Saiseikai Suita Hospital, Gastroenterology
Suita-shi, Osaka, , Japan
Nihon University Itabashi Hospital_Division of Gastro.&Hepa.
Tokyo, , Japan
Albert Schweitzer Ziekenhuis locatie Dordwijk
Dordrecht, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
ETZ Elisabeth
Tilburg, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Gastromed Sp. z o.o.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
ID Clinic Arkadiusz Pisula
Myslowice, Lesser Poland Voivodeship, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Sonomed Sp. Z O.O.
Szczecin, West Pomeranian Voivodeship, Poland
"LANDA" Katarzyna Agata Landa
Krakow, , Poland
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Clinic i Provincial
Barcelona, Catalonia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, España, Spain
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra, Galicia, Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Countries
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Other Identifiers
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U1111-1295-6713
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508170-28
Identifier Type: OTHER
Identifier Source: secondary_id
NN9500-7730
Identifier Type: -
Identifier Source: org_study_id
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