NCT06409130

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol-related Liver Disease

Interventions

Type	Name	Description
DRUG	NNC0194-0499	Administered subcutaneously.
DRUG	Semaglutide	Administered subcutaneously.
DRUG	NNC0194-0499 placebo	Administered subcutaneously.
DRUG	Semaglutide placebo (Group A)	Administered subcutaneously.
DRUG	Cagrilintide + semaglutide	Administered subcutaneously.
DRUG	Cagrilintide	Administered subcutaneously.
DRUG	Cagrilintide placebo	Administered subcutaneously.
DRUG	Semaglutide placebo (Group B)	Administered subcutaneously.

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-11-21
• Completion: 2026-01-12
• First posted: 2024-05-10
• Last updated: 2026-03-12

Locations

102 sites across 14 countries: United States, Australia, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study