DRUG
NNC0194-0499
Administered subcutaneously.
Status
Completed
Phase
Phase 2
Enrollment
270
Locations
102
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
DRUG
Administered subcutaneously.
Timeline
First posted
May 10, 2024
Study start
May 20, 2024
Primary completion
Nov 21, 2025
Study completion
Jan 12, 2026
Results posted
Not reported
Registry updated
Mar 12, 2026
Outcomes
Change in Enhanced Liver Fibrosis (ELF)
Time frame · From week 0 to week 28
Measured as logarithm score
Change in Pro-peptide of Collagen 3 (Pro-C3)
Time frame · From week 0 to week 28
Measured as ratio to baseline
Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)
Time frame · From week 0 to week 28
Measured as ratio to baseline
Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)
Time frame · From week 0 to week 28
Measured as decibel milliwatts (dB/m)
Change in Alanine Aminotransferase (ALT)
Time frame · From week 0 to week 28
Measured as ratio to baseline
Change in Aspartate Aminotransferase (AST)
Time frame · From week 0 to week 28
Measured as ratio to baseline
Number of treatment emergent adverse events
Time frame · From week 0 to week 35
Measured as count of events
Change in Phosphatidylethanol (PEth)
Time frame · From week -4 to week 28
Measured as ratio to baseline
Change in alcohol amount measured by timeline followback (TLFB)
Time frame · From week -4 to week 28
Measured as grams per day
Change in total cholesterol
Time frame · From week 0 to week 28
Measured as ratio to baseline
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients). * Previous participation (i.e., signed informed consent) in this study. If exclusion criteria 7 is met (Vibration Controlled Transient Elastography liver stiffness measurement (LSM) is greater than or equal to 25 Kilopascal (kPa)), a single rescreening is possible at the investigator's discretion. * 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.
Study locations
Australia · Bulgaria · Canada · Czechia · Denmark · France · Germany · Greece · Italy · Japan · Netherlands · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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