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

Launched by NOVO NORDISK A/S · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of three different treatments—NNC0194-0499, cagrilintide, and semaglutide—on liver health and alcohol use in people with alcohol-related liver disease. The goal is to see how these treatments, either alone or in combination, can help reduce liver damage and support individuals in managing their alcohol consumption. The study will last about 39 weeks, and participants will receive one of the treatments or a "dummy" medicine, which means they may not know if they are getting the actual treatment.

To be eligible for the study, participants must be at least 18 years old and have a history of heavy alcohol use for at least five years. They also need to have certain liver health indicators. However, individuals with other serious liver conditions, recent liver-related health issues, or certain medical histories may not qualify. If someone decides to join, they can expect regular visits for assessments and treatments throughout the study period. This trial is currently looking for participants, so it's a great opportunity for those who meet the criteria to contribute to important research on liver health.

Gender

ALL

Eligibility criteria

• 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.