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

Last updated: April 14, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Primary Biliary Cholangitis

Treatment

Cagrilintide + semaglutide

NNC0194-0499 placebo

Semaglutide placebo (Group A)

Clinical Study ID

NCT06409130
NN9500-7730
2023-508170-28
U1111-1295-6713
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  • Age 18 years or above, and at the legal drinking age according to local requirementsat the time of signing the informed consent.

  • Patient-reported history of alcohol overuse for greater than or equal to 5 yearswith an alcohol history of a mean of greater than or equal to 50 grams (male)/40grams (female) pr day for the last year leading up to the time of signing informedconsent.

  • Enhanced Liver Fibrosis (ELF) greater than or equal to 9.0 units.

Exclusion

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 exclusioncriteria 7 is met (Vibration Controlled Transient Elastography liver stiffnessmeasurement (LSM) is greater than or equal to 25 Kilopascal (kPa)), a singlerescreening 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 immunodeficiencyvirus-1 (HIV-1) or HIV-2 antibody (Ab), positive hepatitis C virus (HCV) ribonucleicacid (RNA) at screening (V1) or any known presence of HCV RNA or HBsAg within 2years of screening visit 1 (V1).

  • Presence or history of ascites more than grade 1, variceal bleeding, hepaticencephalopathy, spontaneous bacterial peritonitis, or liver transplantation atscreening (V1).

  • Alcohol hepatitis at randomisation (as defined by National Institute on AlcoholAbuse 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 thiscriterion, 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 bloodplatelets count less than 150,000 per microliter (μL) of blood anoesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must beavailable at V2. *Grade 2: varices projecting by one-third of the luminal diameterthat 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 ofchildbearing potential and not using highly effective contraceptive method with lowuser-dependency.

Study Design

Total Participants: 240
Treatment Group(s): 8
Primary Treatment: Cagrilintide + semaglutide
Phase: 2
Study Start date:
May 20, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

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    Darlinghurst, New South Wales 2010
    Australia

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  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales 2010
    Australia

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  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

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  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

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  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Eastern Clinical Research Unit Box Hill

    Box Hill, Victoria 3128
    Australia

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  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria 3065
    Australia

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  • Austin Health

    Heidelberg, Victoria 3084
    Australia

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  • Fiona Stanley Hospital - Hepatology

    Murdoch, Western Australia 6150
    Australia

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  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

    Gorna Oryahovitsa, 5100
    Bulgaria

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  • "Acibadem City Clinic MHAT Tokuda"

    Sofia, 1407
    Bulgaria

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  • "Acibadem City Clinic UMHAT Tokuda"

    Sofia, 1407
    Bulgaria

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  • "DCC XX - Sofia" EOOD

    Sofia, 1618
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  • Medical Center Synexus Sofia

    Sofia, 1784
    Bulgaria

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  • UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology

    Sofia, 1431
    Bulgaria

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  • UMHAT Aleksandrovska

    Sofia, 1431
    Bulgaria

    Site Not Available

  • University of Calgary Liver Unit-(HMRC)

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • GI Research Inst Foundation

    Vancouver, British Columbia V6Z 2K5
    Canada

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  • GI Research Institute

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • London Health Sciences Centre- University Hospital

    London, Ontario N6A5A5
    Canada

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  • TDDA Specialty Research

    Vaughan, Ontario L4L 4Y7
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  • Ctr de Med Metab de Lanaudiere

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  • Krajská nemocice Liberec, a.s

    Liberec, 460 01
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    Prague 2, 128 08
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    Aalborg, 9000
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  • Herlev Hospital

    Herlev, 2730
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    Hvidovre, 2650
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  • Hvidovre Hospital - Gastroenheden

    Hvidovre, 2650
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  • Odense University Hospital

    Odense C, 5000
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  • Centre Hospitalier Universitaire D'Angers-1

    Angers, 49100
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  • Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez

    Lille, 59000
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  • Groupe Hospitalier Mutualiste Des Portes Du Sud

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  • Universitätsklinikum des Saarlandes - Klinik für Innere Medizin II

    Homburg, 66421
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    Leipzig, 04103
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    Leipzig, 04103
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  • Universitätsklinikum Leipzig, Klinik und Poliklinik

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    Lübeck, 23562
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  • Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

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  • Universitätsmedizin der Johannes-Gutenberg-Universität Mainz - Hepatologie

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsklinikum Münster - Medizinische Klinik B

    Münster, 48149
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    Site Not Available

  • Universitätsklinikum Würzburg, ZIM

    Würzburg, 97080
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  • Universitätsklinikum Würzburg, Zentrum für Innere Medizin (ZIM)

    Würzburg, 97080
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    Thessaloniki, 54642
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  • AOU Careggi Firenze

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria San Martino - IST

    Genova, 16132
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    Site Not Available

  • Ospedale Evangelico Betania

    Naples, 80147
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

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    Bunkyo-ku, Tokyo, 113-8431
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  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804
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    Gifu, 503-8502
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    Ibaraki, 311-0113
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    Site Not Available

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    Suita-shi, Osaka, 564-0013
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  • Nihon University Itabashi Hospital

    Tokyo, 173-8610
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  • ID Clinic Arkadiusz Pisula

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  • Uniwersytecki Szpital Kliniczny w Bialymstoku

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    Szczecin, Zachodniopomorskie 71-685
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  • "LANDA" Katarzyna Agata Landa

    Kraków, 31-156
    Poland

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  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

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  • Hospital Clinic i Provincial

    Barcelona, Cataluña 08036
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, España 47003
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Pontevedra - Hospital de Montecelo

    Pontevedra, Galicia 36004
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • The Institute for Liver Health

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Arizona Liver Center

    Tucson, Arizona 85712
    United States

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  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

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  • OM Research LLC

    Lancaster, California 93534
    United States

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  • California Liver Research Institute

    Pasadena, California 91105
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  • Covenant Metabolic Specialists LLC

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  • Miguel Rebollar PA

    Hialeah, Florida 33012
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  • UF Hepatology Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • UF Hlth Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Univ of Miami/Schiff Ctr

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Covenant Metabolic Specialists LLC

    Sarasota, Florida 34240
    United States

    Site Not Available

  • Covenant Metabolic Specialists LLC

    University Park, Florida 34201
    United States

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  • Rush University Med. Cntr

    Chicago, Illinois 60612
    United States

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  • Kansas Medical Clinic, PA

    Topeka, Kansas 66606
    United States

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  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Boston Medical Center_Cary

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

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  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • DSI Research,LLC

    Springboro, Ohio 45066
    United States

    Active - Recruiting

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC_Center for Liver Care

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Digestive Health Research, TN

    Hermitage, Tennessee 37076
    United States

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  • Texas Clinical Research Institute

    Arlington, Texas 76012
    United States

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  • The Liver Institute

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • South Texas Research Institute

    Edinburg, Texas 78539
    United States

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  • Baylor St. Luke's Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Research Institute

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Liver Specialists of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Amer. Rrsch Corp-TX Liver Inst

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Pinnacle Clinical Research

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Liver Specialists of Texas

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Velocity Clinical Res, Waco

    Waco, Texas 76710
    United States

    Active - Recruiting

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