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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

May 20, 2024

Primary Completion Date

November 13, 2025

Study Completion Date

January 1, 2026

Conditions
Alcohol-related Liver Disease
Interventions
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.

Trial Locations (80)

1407

"Acibadem City Clinic UMHAT Tokuda", Sofia

1431

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

1618

"DCC XX - Sofia EOOD", Sofia

1784

Medical Center Synexus Sofia, Sofia

2010

Momentum Clinical Research Darlinghurst, Darlinghurst

2145

Westmead Hospital, Westmead

2650

Hvidovre Hospital - Gastroenheden, Hvidovre

2730

Herlev Hospital, Herlev

3065

St Vincent's Hospital (Melbourne), Fitzroy

3084

Austin Health, Heidelberg

3128

Eastern Clinical Research Unit Box Hill, Box Hill

5000

Odense University Hospital, Odense C

5100

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

6150

Fiona Stanley Hospital - Hepatology, Murdoch

9000

Aalborg Universitetshospital, Aalborg

11527

"Laiko General Hospital of Athens", Goudi/Athens

12462

University Hospital of Athens ATTIKON, Athens

16132

IRCCS Ospedale Policlinico San Martino, Genova

19104

University of Pennsylvania Hospital, Philadelphia

32224

UF Hlth Jacksonville, Jacksonville

33012

Miguel Rebollar PA, Hialeah

33912

Covenant Metabolic Specialists LLC, Fort Myers

34201

Covenant Metabolic Specialists LLC, University Park

35128

Azienda Ospedaliera di Padova, Padua

36004

Complejo Hospitalario de Pontevedra - Hospital de Montecelo, Pontevedra

37076

Digestive Health Research, TN, Hermitage

39008

Hospital Universitario Marqués de Valdecilla, Santander

47003

Hospital Clínico Universitario de Valladolid, Valladolid

49100

Centre Hospitalier Universitaire D'Angers-1, Angers

50134

AOU Careggi Firenze, Florence

54642

'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki

55131

Universitätsmedizin der JGU Mainz - Hepatologie, Mainz

55902

Mayo Clinic Rochester, Rochester

59000

Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez, Lille

66421

Universitätsklinikum des Saarlandes - Innere Med. II, Homburg

66606

Kansas Medical Clinic, PA, Topeka

69200

Centre de Recherche Clinique Portes Du Sud, Vénissieux

75203

The Liver Institute, Dallas

76012

Texas Clinical Research Institute, Arlington

76710

Velocity Clinical Res, Waco, Waco

77030

Baylor St. Luke's Medical Center, Houston

77079

Houston Research Institute, Houston

78215

Amer. Rrsch Corp-TX Liver Inst, San Antonio

80147

Fondazione Evangelica Betania - UO Epatologia, Naples

85224

The Institute for Liver Health, Chandler

85712

Arizona Liver Center, Tucson

85715

Del Sol Research Management, LLC, Tucson

89106

Jubilee Clinical Research, Inc., Las Vegas

91105

California Liver Research Institute, Pasadena

93534

OM Research LLC, Lancaster

97080

Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM), Würzburg

02118

Boston Medical Center_Cary, Boston

T2N 4Z6

University of Calgary Liver Unit-(HMRC), Calgary

V6Z 2K5

GI Research Inst Foundation, Vancouver

N6A5A5

London Health Sciences Centre- University Hospital, London

L4L 4Y7

TDDA Specialty Research, Vaughan

J6X 4P7

Ctr de Med Metab de Lanaudiere, Terrebonne

460 01

Krajská nemocice Liberec, a.s, Liberec

04103

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

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCS, Roma

113-8431

Juntendo University Hospital, Gastroenterology, Bunkyo-ku, Tokyo

260-0804

Akaicho Clinic, Chiba-shi, Chiba

503-8502

Ogaki Municipal Hospital_Gastroenterology and Hepatology, Gifu

311-0113

Naka Kinen Clinic_Internal medicine, Ibaraki

920-8530

Ishikawa Prefectural Central Hospital_Gastroenterology, Kanazawa-shi, Ishikawa

862-8655

Kumamoto Shinto General Hospital_Liver・Gastroenterology, Kumamoto-shi, Kumamoto

105-8470

Toranomon Hospital, Hepatology, Minato-ku, Tokyo

901-2492

Heartlife Hospital_Liver internal medicine, Nakagamigun, Okinawa

870-0837

Oita Cardiovascular Hospital_Gastroenterology, Oita-shi, Oita

062-8618

JCHO Hokkaido Hospital_Digestive Disease Center, Sapporo-shi, Hokkaido

564-0013

Saiseikai Suita Hospital, Gastroenterology, Suita-shi, Osaka

173-8610

Nihon University Itabashi Hospital_Division of Gastro.&Hepa., Tokyo

3015 GD

Erasmus MC, Rotterdam

85-605

Centrum Medyczne Intercor Sp. z o.o., Bydgoszcz

87-100

Gastromed Sp. z o.o., Torun

41-400

ID Clinic Arkadiusz Pisula, Myslowice

02-507

PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warsaw

71-685

Sonomed Sp. Z O.O., Szczecin

08036

Hospital Clinic i Provincial, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY