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

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

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.

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-20

Primary Completion

2025-11-21

Completion

2026-01-12

FDA Drug

Yes

Countries

• United States
• Australia
• Bulgaria
• Canada
• Czechia
• Denmark
• France
• Germany
• Greece
• Italy
• Japan
• Netherlands
• Poland
• Spain

Study Locations