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GLP-1 Receptor Agonist
NNC0194-0499, Cagrilintide, and Semaglutide for Alcoholic Liver Disease
Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent
Be older than 18 years old
Must not have
Alcohol hepatitis at randomisation (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA))
Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week -4 to week 28
Summary
This trial will investigate how three different medications, NNC0194-0499, cagrilintide, and semaglutide, affect liver damage and alcohol use in people with alcoholic liver
Who is the study for?
This trial is for individuals with alcoholic liver disease. Participants should be willing to receive injections of either the study medications or placebos and be available for the duration of the 39-week study. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions, lifestyle factors, or other medications that could affect participation.
What is being tested?
The trial is testing how NNC0194-0499, cagrilintide, semaglutide alone or in combination can impact liver damage and alcohol use in people with alcoholic liver disease. Treatments are assigned randomly and include both active drugs and placebos (dummy medicine) to compare effects.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with such medications may include digestive issues like nausea or diarrhea, potential allergic reactions at injection sites, changes in appetite or weight loss/gain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and legally allowed to drink alcohol.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with alcohol hepatitis.
Select...
My liver disease is not caused by alcohol.
Select...
I have not had severe liver problems or a liver transplant.
Select...
I have or had significant varices due to liver issues.
Select...
I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week -4 to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week -4 to week 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Enhanced Liver Fibrosis (ELF)
Secondary study objectives
Change in Alanine Aminotransferase (ALT)
Change in Aspartate Aminotransferase (AST)
Change in Phosphatidylethanol (PEth)
+6 moreTrial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC0194-0499 placebo + semaglutideExperimental Treatment2 Interventions
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
Group II: NNC0194-0499 + semaglutide placeboExperimental Treatment2 Interventions
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
Group III: NNC0194-0499 + semaglutideExperimental Treatment2 Interventions
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
Group IV: Cagrilintide + semaglutide placeboExperimental Treatment2 Interventions
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
Group V: CagriSemaExperimental Treatment1 Intervention
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
Group VI: Cagrilintide placebo + semaglutide placeboPlacebo Group2 Interventions
Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.
Group VII: NNC0194-0499 placebo + semaglutide placeboPlacebo Group2 Interventions
Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cagrilintide
2023
Completed Phase 1
~150
NNC0194-0499
2017
Completed Phase 1
~280
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,559 Previous Clinical Trials
3,646,167 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,673 Total Patients Enrolled