Alcohol-related Liver Disease
Conditions
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.
Interventions
DRUGNNC0194-0499
Administered subcutaneously.
DRUGSemaglutide
Administered subcutaneously.
DRUGNNC0194-0499 placebo
Administered subcutaneously.
DRUGSemaglutide placebo (Group A)
Administered subcutaneously.
DRUGCagrilintide + semaglutide
Administered subcutaneously.
DRUGCagrilintide
Administered subcutaneously.
Administered subcutaneously.
DRUGSemaglutide placebo (Group B)
Administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Enhanced Liver Fibrosis (ELF) | From week 0 to week 28 | Measured as logarithm score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pro-peptide of Collagen 3 (Pro-C3) | From week 0 to week 28 | Measured as ratio to baseline |
| Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE) | From week 0 to week 28 | Measured as ratio to baseline |
| Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP) | From week 0 to week 28 | Measured as decibel milliwatts (dB/m) |
| Change in Alanine Aminotransferase (ALT) | From week 0 to week 28 | Measured as ratio to baseline |
| Change in Aspartate Aminotransferase (AST) | From week 0 to week 28 | Measured as ratio to baseline |
| Number of treatment emergent adverse events | From week 0 to week 35 | Measured as count of events |
| Change in Phosphatidylethanol (PEth) | From week -4 to week 28 | Measured as ratio to baseline |
| Change in alcohol amount measured by timeline followback (TLFB) | From week -4 to week 28 | Measured as grams per day |
| Change in total cholesterol | From week 0 to week 28 | Measured as ratio to baseline |
Countries
Australia, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed