Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol-related Liver Disease

In brief

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.

Key facts

Study ID

NCT06409130

Run by

Novo Nordisk A/S

People needed

270

Starts

2024-05-20

Expected to finish

2026-01-12

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

Where it is running

• 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
• The Institute for Liver Health — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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