A Phase 2 interventional study of NNC0194-0499 and Semaglutide in Alcohol-related Liver Disease, sponsored by Novo Nordisk A/S. Completed at 102 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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.
Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
Drug: NNC0194-0499 · Drug: Semaglutide
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
Drug: NNC0194-0499 · Drug: Semaglutide placebo (Group A)
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
Drug: Semaglutide · Drug: NNC0194-0499 placebo
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
Drug: NNC0194-0499 placebo · Drug: Semaglutide placebo (Group A)
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
Drug: Cagrilintide + semaglutide
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
Drug: Cagrilintide · Drug: Semaglutide placebo (Group B)
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.
Drug: Cagrilintide placebo · Drug: Semaglutide placebo (Group B)
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Administered subcutaneously.
Change in Enhanced Liver Fibrosis (ELF)
Measured as logarithm score
Time frame: From week 0 to week 28
Change in Pro-peptide of Collagen 3 (Pro-C3)
Measured as ratio to baseline
Time frame: From week 0 to week 28
Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)
Measured as ratio to baseline
Time frame: From week 0 to week 28
Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)
Measured as decibel milliwatts (dB/m)
Time frame: From week 0 to week 28
Change in Alanine Aminotransferase (ALT)
Measured as ratio to baseline
Time frame: From week 0 to week 28
Change in Aspartate Aminotransferase (AST)
Measured as ratio to baseline
Time frame: From week 0 to week 28
Number of treatment emergent adverse events
Measured as count of events
Time frame: From week 0 to week 35
Change in Phosphatidylethanol (PEth)
Measured as ratio to baseline
Time frame: From week -4 to week 28
Change in alcohol amount measured by timeline followback (TLFB)
Measured as grams per day
Time frame: From week -4 to week 28
Change in total cholesterol
Measured as ratio to baseline
Time frame: From week 0 to week 28
Showing the first 100 of 102 sites across 14 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S