Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
Effects of NNC0194-0499 Alone and in Combination With Semaglutide, of Semaglutide Alone, and of Cagrilintide Alone and in Combination With Semaglutide on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
3 other identifiers
interventional
270
14 countries
102
Brief Summary
The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedStudy Start
First participant enrolled
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2026
CompletedMarch 12, 2026
March 1, 2026
1.5 years
May 7, 2024
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Enhanced Liver Fibrosis (ELF)
Measured as logarithm score
From week 0 to week 28
Secondary Outcomes (9)
Change in Pro-peptide of Collagen 3 (Pro-C3)
From week 0 to week 28
Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)
From week 0 to week 28
Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)
From week 0 to week 28
Change in Alanine Aminotransferase (ALT)
From week 0 to week 28
Change in Aspartate Aminotransferase (AST)
From week 0 to week 28
- +4 more secondary outcomes
Study Arms (7)
NNC0194-0499 + semaglutide
EXPERIMENTALGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
NNC0194-0499 + semaglutide placebo
EXPERIMENTALGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
NNC0194-0499 placebo + semaglutide
EXPERIMENTALGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
NNC0194-0499 placebo + semaglutide placebo
PLACEBO COMPARATORGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
CagriSema
EXPERIMENTALGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
Cagrilintide + semaglutide placebo
EXPERIMENTALGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
Cagrilintide placebo + semaglutide placebo
PLACEBO COMPARATORGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.
Interventions
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Eligibility Criteria
You may qualify if:
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- 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.
You may not qualify if:
- Known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (102)
The Institute for Liver Health
Chandler, Arizona, 85224, United States
Arizona Liver Center
Tucson, Arizona, 85712, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
OM Research LLC
Lancaster, California, 93534, United States
California Liver Research Institute
Pasadena, California, 91105, United States
Covenant Metabolic Specialists LLC
Fort Myers, Florida, 33912, United States
Miguel Rebollar PA
Hialeah, Florida, 33012, United States
UF Hlth Jacksonville
Jacksonville, Florida, 32224, United States
Univ of Miami/Schiff Ctr
Miami, Florida, 33136, United States
Covenant Metabolic Specialists LLC
University Park, Florida, 34201, United States
Rush University Med. Cntr
Chicago, Illinois, 60612, United States
Kansas Medical Clinic, PA
Topeka, Kansas, 66606, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Boston Medical Center_Cary
Boston, Massachusetts, 02118, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
DSI Research,LLC
Springboro, Ohio, 45066, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
UPMC_Center for Liver Care
Pittsburgh, Pennsylvania, 15213, United States
Digestive Health Research, TN
Hermitage, Tennessee, 37076, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
The Liver Institute
Dallas, Texas, 75203, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Houston Research Institute
Houston, Texas, 77079, United States
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, 78215, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Liver Specialists of Texas
Sugar Land, Texas, 77479, United States
Velocity Clinical Res, Waco
Waco, Texas, 76710, United States
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Westmead Hospital - Storr Liver Centre
Westmead, New South Wales, 2145, Australia
Eastern Clinical Research Unit Box Hill
Box Hill, Victoria, 3128, Australia
St Vincent's Hospital Melbourne - Gastroenterology Department
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Fiona Stanley Hospital - Hepatology
Murdoch, Western Australia, 6150, Australia
MHAT St. Ivan Rilski Gorna Oriahovitsa EOOD
Gorna Oryahovitsa, 5100, Bulgaria
Acibadem City Clinic UMHAT Tokuda EAD, Gastroenterology
Sofia, 1407, Bulgaria
UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski EAD, Gastroenterology
Sofia, 1431, Bulgaria
DCC XX - Sofia EOOD, Gastroenterology
Sofia, 1618, Bulgaria
Medical Center Synexus Sofia EOOD
Sofia, 1784, Bulgaria
University of Calgary Liver Unit-(HMRC)
Calgary, Alberta, T2N 4Z6, Canada
GI Research Inst Foundation
Vancouver, British Columbia, V6Z 2K5, Canada
London Health Sciences Centre- University Hospital
London, Ontario, N6A5A5, Canada
TDDA Specialty Research
Vaughan, Ontario, L4L 4Y7, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, J6X 4P7, Canada
Krajská nemocice Liberec, a.s
Liberec, 460 01, Czechia
Vseobecna Fakultni nemocnice v Praze
Prague, 128 08, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Herlev Hospital - Gastroenterology and Hepatology, Clinic 3
Herlev, 2730, Denmark
Hvidovre Hospital - Gastroenheden
Hvidovre, 2650, Denmark
Odense University Hospital - FLASH - Centre for Liver Research
Odense C, 5000, Denmark
Centre Hospitalier Universitaire D'Angers
Angers, 49100, France
Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
Lille, 59000, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, 69200, France
Universität des Saarlandes - Innere Med. II
Homburg, 66421, Germany
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, 04103, Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, 04103, Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, 23562, Germany
Universitätsmedizin der JGU Mainz - Hepatologie
Mainz, 55131, Germany
Universitätsklinikum Münster - Medizinische Klinik B
Münster, 48149, Germany
Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)
Würzburg, 97080, Germany
University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
"Laiko" General Hospital of Athens
Goudi/Athens, 11527, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
AOU Careggi Firenze
Florence, Tuscany, 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Fondazione Evangelica Betania - UO Epatologia
Naples, 80147, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Roma, 00168, Italy
Juntendo University Hospital, Gastroenterology
Bunkyo-ku, Tokyo, 113-8431, Japan
Juntendo University Hospital_Gastroenterology
Bunkyo-ku, Tokyo, 113-8431, Japan
Akaicho Clinic
Chiba-shi, Chiba, 260-0804, Japan
Ogaki Municipal Hospital_Gastroenterology and Hepatology
Gifu, 503-8502, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Ishikawa Prefectural Central Hospital_Gastroenterology
Kanazawa-shi, Ishikawa, 920-8530, Japan
Kumamoto Shinto General Hospital_Liver・Gastroenterology
Kumamoto-shi, Kumamoto, 862-8655, Japan
Toranomon Hospital, Hepatology
Minato-ku, Tokyo, 105-8470, Japan
Heartlife Hospital_Liver internal medicine
Nakagamigun, Okinawa, 901-2492, Japan
Oita Cardiovascular Hospital_Gastroenterology
Oita-shi, Oita, 870-0837, Japan
JCHO Hokkaido Hospital_Digestive Disease Center
Sapporo-shi, Hokkaido, 062-8618, Japan
Saiseikai Suita Hospital, Gastroenterology
Suita-shi, Osaka, 564-0013, Japan
Nihon University Itabashi Hospital_Division of Gastro.&Hepa.
Tokyo, 173-8610, Japan
Albert Schweitzer Zkh, Dordwijk
Dordrecht, 3318 AT, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland
Gastromed Sp. z o.o.
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 30-688, Poland
ID Clinic Arkadiusz Pisula
Myslowice, Lesser Poland Voivodeship, 41-400, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, Masovian Voivodeship, 02-507, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-540, Poland
Sonomed Sp. Z O.O.
Szczecin, West Pomeranian Voivodeship, 71-685, Poland
"LANDA" Katarzyna Agata Landa
Krakow, 31-156, Poland
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clinic i Provincial
Barcelona, Catalonia, 08036, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, España, 47003, Spain
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra, Galicia, 36004, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2024
First Posted
May 10, 2024
Study Start
May 20, 2024
Primary Completion
November 21, 2025
Study Completion
January 12, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com