Current partner codePEPTIDESDE
NCT06409130·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

270

Locations

102

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    May 10, 2024

  2. Study start

    May 20, 2024

  3. Primary completion

    Nov 21, 2025

  4. Study completion

    Jan 12, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 12, 2026

Outcomes

What the study measures.

Primary outcomes

Change in Enhanced Liver Fibrosis (ELF)

Time frame · From week 0 to week 28

Measured as logarithm score

Secondary outcomes

Change in Pro-peptide of Collagen 3 (Pro-C3)

Time frame · From week 0 to week 28

Measured as ratio to baseline

Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)

Time frame · From week 0 to week 28

Measured as ratio to baseline

Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)

Time frame · From week 0 to week 28

Measured as decibel milliwatts (dB/m)

Change in Alanine Aminotransferase (ALT)

Time frame · From week 0 to week 28

Measured as ratio to baseline

Change in Aspartate Aminotransferase (AST)

Time frame · From week 0 to week 28

Measured as ratio to baseline

Number of treatment emergent adverse events

Time frame · From week 0 to week 35

Measured as count of events

Change in Phosphatidylethanol (PEth)

Time frame · From week -4 to week 28

Measured as ratio to baseline

Change in alcohol amount measured by timeline followback (TLFB)

Time frame · From week -4 to week 28

Measured as grams per day

Change in total cholesterol

Time frame · From week 0 to week 28

Measured as ratio to baseline

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

102 registered sites.

Australia · Bulgaria · Canada · Czechia · Denmark · France · Germany · Greece · Italy · Japan · Netherlands · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

The Institute for Liver Health

Chandler, Arizona, United States

Arizona Liver Center

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

OM Research LLC

Lancaster, California, United States

California Liver Research Institute

Pasadena, California, United States

Covenant Metabolic Specialists LLC

Fort Myers, Florida, United States

Miguel Rebollar PA

Hialeah, Florida, United States

UF Hlth Jacksonville

Jacksonville, Florida, United States

Univ of Miami/Schiff Ctr

Miami, Florida, United States

Covenant Metabolic Specialists LLC

University Park, Florida, United States

Rush University Med. Cntr

Chicago, Illinois, United States

Kansas Medical Clinic, PA

Topeka, Kansas, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Boston Medical Center_Cary

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, United States

DSI Research,LLC

Springboro, Ohio, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

UPMC_Center for Liver Care

Pittsburgh, Pennsylvania, United States

Digestive Health Research, TN

Hermitage, Tennessee, United States

Texas Clinical Research Institute

Arlington, Texas, United States

The Liver Institute

Dallas, Texas, United States

South Texas Research Institute

Edinburg, Texas, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.