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New drug combo targets liver damage and alcohol use in one shot

NCT ID NCT06409130

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether certain drugs (NNC0194-0499, semaglutide, and cagrilintide) can reduce liver damage and alcohol use in people with alcohol-related liver disease. About 270 adults with a history of heavy drinking took part. Participants received different drug combinations or a placebo for up to 39 weeks. The goal was to see if these treatments could help control the disease and reduce drinking.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

270 people

The number who actually took part.

Started

May 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcoholic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol related liver disease

Contacts and locations

Locations

  • "LANDA" Katarzyna Agata Landa

    Krakow, 31-156, Poland

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527, Greece

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • AOU Careggi Firenze

    Florence, Tuscany, 50134, Italy

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Acibadem City Clinic UMHAT Tokuda EAD, Gastroenterology

    Sofia, 1407, Bulgaria

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804, Japan

  • Albert Schweitzer Zkh, Dordwijk

    Dordrecht, 3318 AT, Netherlands

  • Amer. Rrsch Corp-TX Liver Inst

    San Antonio, Texas, 78215, United States

  • Arizona Liver Center

    Tucson, Arizona, 85712, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera di Padova

    Padova, 35128, Italy

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • Boston Medical Center_Cary

    Boston, Massachusetts, 02118, United States

  • California Liver Research Institute

    Pasadena, California, 91105, United States

  • Centre Hospitalier Universitaire D'Angers

    Angers, 49100, France

  • Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez

    Lille, 59000, France

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200, France

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland

  • Complejo Hospitalario de Pontevedra - Hospital de Montecelo

    Pontevedra, Galicia, 36004, Spain

  • Covenant Metabolic Specialists LLC

    Fort Myers, Florida, 33912, United States

  • Covenant Metabolic Specialists LLC

    University Park, Florida, 34201, United States

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7, Canada

  • DCC XX - Sofia EOOD, Gastroenterology

    Sofia, 1618, Bulgaria

  • DSI Research,LLC

    Springboro, Ohio, 45066, United States

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • Digestive Health Research, TN

    Hermitage, Tennessee, 37076, United States

  • ETZ Elisabeth

    Tilburg, 5022 GC, Netherlands

  • Eastern Clinical Research Unit Box Hill

    Box Hill, Victoria, 3128, Australia

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fiona Stanley Hospital - Hepatology

    Murdoch, Western Australia, 6150, Australia

  • Fondazione Evangelica Betania - UO Epatologia

    Naples, 80147, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Roma, 00168, Italy

  • GI Research Inst Foundation

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Gastromed Sp. z o.o.

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Heartlife Hospital_Liver internal medicine

    Nakagamigun, Okinawa, 901-2492, Japan

  • Herlev Hospital - Gastroenterology and Hepatology, Clinic 3

    Herlev, 2730, Denmark

  • Hospital Clinic i Provincial

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, España, 47003, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Houston Research Institute

    Houston, Texas, 77079, United States

  • Hvidovre Hospital - Gastroenheden

    Hvidovre, 2650, Denmark

  • ID Clinic Arkadiusz Pisula

    Myslowice, Lesser Poland Voivodeship, 41-400, Poland

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Ishikawa Prefectural Central Hospital_Gastroenterology

    Kanazawa-shi, Ishikawa, 920-8530, Japan

  • JCHO Hokkaido Hospital_Digestive Disease Center

    Sapporo-shi, Hokkaido, 062-8618, Japan

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106, United States

  • Juntendo University Hospital, Gastroenterology

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Juntendo University Hospital_Gastroenterology

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kansas Medical Clinic, PA

    Topeka, Kansas, 66606, United States

  • Krajská nemocice Liberec, a.s

    Liberec, 460 01, Czechia

  • Kumamoto Shinto General Hospital_Liver・Gastroenterology

    Kumamoto-shi, Kumamoto, 862-8655, Japan

  • Liver Specialists of Texas

    Sugar Land, Texas, 77479, United States

  • London Health Sciences Centre- University Hospital

    London, Ontario, N6A5A5, Canada

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105, United States

  • MHAT St. Ivan Rilski Gorna Oriahovitsa EOOD

    Gorna Oryahovitsa, 5100, Bulgaria

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902, United States

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784, Bulgaria

  • Miguel Rebollar PA

    Hialeah, Florida, 33012, United States

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010, Australia

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • Nihon University Itabashi Hospital_Division of Gastro.&Hepa.

    Tokyo, 173-8610, Japan

  • OM Research LLC

    Lancaster, California, 93534, United States

  • Odense University Hospital - FLASH - Centre for Liver Research

    Odense C, 5000, Denmark

  • Ogaki Municipal Hospital_Gastroenterology and Hepatology

    Gifu, 503-8502, Japan

  • Oita Cardiovascular Hospital_Gastroenterology

    Oita-shi, Oita, 870-0837, Japan

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229, United States

  • Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH

    Leipzig, 04103, Germany

  • Rush University Med. Cntr

    Chicago, Illinois, 60612, United States

  • Saiseikai Suita Hospital, Gastroenterology

    Suita-shi, Osaka, 564-0013, Japan

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Sonomed Sp. Z O.O.

    Szczecin, West Pomeranian Voivodeship, 71-685, Poland

  • South Texas Research Institute

    Edinburg, Texas, 78539, United States

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne - Gastroenterology Department

    Fitzroy, Victoria, 3065, Australia

  • TDDA Specialty Research

    Vaughan, Ontario, L4L 4Y7, Canada

  • Texas Clinical Research Institute

    Arlington, Texas, 76012, United States

  • The Institute for Liver Health

    Chandler, Arizona, 85224, United States

  • The Liver Institute

    Dallas, Texas, 75203, United States

  • Toranomon Hospital, Hepatology

    Minato-ku, Tokyo, 105-8470, Japan

  • UF Hlth Jacksonville

    Jacksonville, Florida, 32224, United States

  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

    Sofia, 1431, Bulgaria

  • UMHAT Sveti Ivan Rilski EAD, Gastroenterology

    Sofia, 1431, Bulgaria

  • UPMC_Center for Liver Care

    Pittsburgh, Pennsylvania, 15213, United States

  • Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck

    Lübeck, 23562, Germany

  • Univ of Miami/Schiff Ctr

    Miami, Florida, 33136, United States

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462, Greece

  • University of Calgary Liver Unit-(HMRC)

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • Universität des Saarlandes - Innere Med. II

    Homburg, 66421, Germany

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie

    Leipzig, 04103, Germany

  • Universitätsklinikum Münster - Medizinische Klinik B

    Münster, 48149, Germany

  • Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

    Würzburg, 97080, Germany

  • Universitätsmedizin der JGU Mainz - Hepatologie

    Mainz, 55131, Germany

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-540, Poland

  • Velocity Clinical Res, Waco

    Waco, Texas, 76710, United States

  • Vseobecna Fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Westmead Hospital - Storr Liver Centre

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.