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

Conditions

• Alcohol-related Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NNC0194-0499 — DRUG
  Administered subcutaneously.
• Semaglutide — DRUG
  Administered subcutaneously.
• NNC0194-0499 placebo — DRUG
  Administered subcutaneously.
• Semaglutide placebo (Group A) — DRUG
  Administered subcutaneously.
• Cagrilintide + semaglutide — DRUG
  Administered subcutaneously.
• Cagrilintide — DRUG
  Administered subcutaneously.
• Cagrilintide placebo — DRUG
  Administered subcutaneously.
• Semaglutide placebo (Group B) — DRUG
  Administered subcutaneously.

Study Details

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 Dates

Start date

May 20, 2024

Status verified

Mar 2026

Primary completion

Nov 21, 2025

Completion

Jan 12, 2026

Study Design

Enrollment

270 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NNC0194-0499 + semaglutide
  Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
• Experimental: NNC0194-0499 + semaglutide placebo
  Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
• Experimental: NNC0194-0499 placebo + semaglutide
  Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
• Placebo Comparator: NNC0194-0499 placebo + semaglutide placebo
  Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
• Experimental: CagriSema
  Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
• Experimental: Cagrilintide + semaglutide placebo
  Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
• Placebo Comparator: Cagrilintide placebo + semaglutide placebo
  Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.

Primary Outcome Measure

Change in Enhanced Liver Fibrosis (ELF) [ Time Frame: From week 0 to week 28 ]

Locations (29)

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