Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
NCT06409130
Phase
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
Novo Nordisk A/S
Start date
2024-05-20
Number of sites
- 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.
- Short title
- Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-01-12
- First posted
- 2024-05-10
- Registry last updated
- 2026-03-12
- Primary completion date
- 2025-11-21
- Start date
- 2024-05-20
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06409130
- ClinicalTrials.gov ID
- NCT06409130
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Change in Enhanced Liver Fibrosis (ELF)
Timeframe: From week 0 to week 28
Measured as logarithm score
Change in Pro-peptide of Collagen 3 (Pro-C3)
Timeframe: From week 0 to week 28
Measured as ratio to baseline
Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)
Timeframe: From week 0 to week 28
Measured as ratio to baseline
Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)
Timeframe: From week 0 to week 28
Measured as decibel milliwatts (dB/m)
Change in Alanine Aminotransferase (ALT)
Timeframe: From week 0 to week 28
Measured as ratio to baseline
Change in Aspartate Aminotransferase (AST)
Timeframe: From week 0 to week 28
Measured as ratio to baseline
Number of treatment emergent adverse events
Timeframe: From week 0 to week 35
Measured as count of events
Change in Phosphatidylethanol (PEth)
Timeframe: From week -4 to week 28
Measured as ratio to baseline
Change in alcohol amount measured by timeline followback (TLFB)
Timeframe: From week -4 to week 28
Measured as grams per day
Change in total cholesterol
Timeframe: From week 0 to week 28
Measured as ratio to baseline
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent.
- Patient-reported history of alcohol overuse for greater than or equal to 5 years with an alcohol history of a mean of greater than or equal to 50 grams (male)/40 grams (female) pr day for the last year leading up to the time of signing informed consent.
- Enhanced Liver Fibrosis (ELF) greater than or equal to 9.0 units.
- Known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients).
- Previous participation (i.e., signed informed consent) in this study. If exclusion criteria 7 is met (Vibration Controlled Transient Elastography liver stiffness measurement (LSM) is greater than or equal to 25 Kilopascal (kPa)), a single rescreening is possible at the investigator's discretion.
- Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD).
- Positive hepatitis B surface antigen (HBsAg), positive human immunodeficiency virus-1 (HIV-1) or HIV-2 antibody (Ab), positive hepatitis C virus (HCV) ribonucleic acid (RNA) at screening (V1) or any known presence of HCV RNA or HBsAg within 2 years of screening visit 1 (V1).
- Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at screening (V1).
- Alcohol hepatitis at randomisation (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA)).
- Vibration Controlled Transient Elastography liver stiffness measurement (LSM) greater than or equal to 25 kPa at visit 2 (V2). If participants meet this criterion, rescreening is allowed once.
- Presence or history of gastro-oesophageal varices greater than or equal to grade 2* at V2. For participants with LSM greater than or equal to 20 kPa as well as blood platelets count less than 150,000 per microliter (μL) of blood an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must be available at V2. *Grade 2: varices projecting by one-third of the luminal diameter that cannot be compressed with air insufflation4.
- Body mass index (BMI) less than or equal to 25 Kilogram Per Square Meter (kg/m^2).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method with low user-dependency.
Sources for eligibility
- The Institute for Liver HealthChandler, United States
- Arizona Liver CenterTucson, United States
- Del Sol Research Management, LLCTucson, United States
- OM Research LLCLancaster, United States
- California Liver Research InstitutePasadena, United States
- Covenant Metabolic Specialists LLCFort Myers, United States
- Miguel Rebollar PAHialeah, United States
- UF Hlth JacksonvilleJacksonville, United States
- Univ of Miami/Schiff CtrMiami, United States
- Covenant Metabolic Specialists LLCUniversity Park, United States
- Rush University Med. CntrChicago, United States
- Kansas Medical Clinic, PATopeka, United States
- Louisiana Research Center, LLCShreveport, United States
- Boston Medical Center_CaryBoston, United States
- Mayo Clinic RochesterRochester, United States
- Jubilee Clinical Research, Inc.Las Vegas, United States
- DSI Research,LLCSpringboro, United States
- University of Pennsylvania HospitalPhiladelphia, United States
- UPMC_Center for Liver CarePittsburgh, United States
- Digestive Health Research, TNHermitage, United States
- Texas Clinical Research InstituteArlington, United States
- The Liver InstituteDallas, United States
- South Texas Research InstituteEdinburg, United States
- Baylor St. Luke's Medical CenterHouston, United States
- Houston Research InstituteHouston, United States
And 77 more, listed on the interactive page.
Sources for sites
- 2023
- 2023-508170-28
- U1111-1295-6713
Sources for references