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Alcohol-related Liver DiseasePhase 2NCT06409130

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

A Phase 2 study testing NNC0194-0499, Semaglutide and Cagrilintide + semaglutide in people with Alcohol-related Liver Disease, run by Novo Nordisk A/S at 102 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol-related Liver Disease
What is being tested?
NNC0194-0499, Semaglutide and Cagrilintide + semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
102 sitesin 14 countries
Study dates
20 May 2024to 12 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)).
Show all 10Show fewer
  • 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.

Trial locations and contacts

102 sites in 14 countries.

102 sites in 14 countries

United States29 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Boston Medical Center_Cary

    Boston, Massachusetts, 02118

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • Rush University Med. Cntr

    Chicago, Illinois, 60612

  • The Liver Institute

    Dallas, Texas, 75203

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • Covenant Metabolic Specialists LLC

    Fort Myers, Florida, 33912

  • Digestive Health Research, TN

    Hermitage, Tennessee, 37076

  • Miguel Rebollar PA

    Hialeah, Florida, 33012

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Houston Research Institute

    Houston, Texas, 77079

  • UF Hlth Jacksonville

    Jacksonville, Florida, 32224

  • OM Research LLC

    Lancaster, California, 93534

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106

  • Univ of Miami/Schiff Ctr

    Miami, Florida, 33136

  • California Liver Research Institute

    Pasadena, California, 91105

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • UPMC_Center for Liver Care

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

  • Amer. Rrsch Corp-TX Liver Inst

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • DSI Research,LLC

    Springboro, Ohio, 45066

  • Liver Specialists of Texas

    Sugar Land, Texas, 77479

  • Kansas Medical Clinic, PA

    Topeka, Kansas, 66606

  • Arizona Liver Center

    Tucson, Arizona, 85712

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Covenant Metabolic Specialists LLC

    University Park, Florida, 34201

  • Velocity Clinical Res, Waco

    Waco, Texas, 76710

Other trials in United States

Japan13 sites

  • Juntendo University Hospital, Gastroenterology

    Bunkyo-ku, Tokyo, 113-8431

  • Juntendo University Hospital_Gastroenterology

    Bunkyo-ku, Tokyo, 113-8431

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • Ogaki Municipal Hospital_Gastroenterology and Hepatology

    Gifu, 503-8502

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Ishikawa Prefectural Central Hospital_Gastroenterology

    Kanazawa-shi, Ishikawa, 920-8530

  • Kumamoto Shinto General Hospital_Liver・Gastroenterology

    Kumamoto-shi, Kumamoto, 862-8655

  • Toranomon Hospital, Hepatology

    Minato-ku, Tokyo, 105-8470

  • Heartlife Hospital_Liver internal medicine

    Nakagamigun, Okinawa, 901-2492

  • Oita Cardiovascular Hospital_Gastroenterology

    Oita-shi, Oita, 870-0837

  • JCHO Hokkaido Hospital_Digestive Disease Center

    Sapporo-shi, Hokkaido, 062-8618

  • Saiseikai Suita Hospital, Gastroenterology

    Suita-shi, Osaka, 564-0013

  • Nihon University Itabashi Hospital_Division of Gastro.&Hepa.

    Tokyo, 173-8610

Other trials in Japan

Australia8 sites

  • Eastern Clinical Research Unit Box Hill

    Box Hill, Victoria, 3128

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne - Gastroenterology Department

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Fiona Stanley Hospital - Hepatology

    Murdoch, Western Australia, 6150

  • Westmead Hospital - Storr Liver Centre

    Westmead, New South Wales, 2145

Other trials in Australia

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-540

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-688

  • "LANDA" Katarzyna Agata Landa

    Krakow, 31-156

  • ID Clinic Arkadiusz Pisula

    Myslowice, Lesser Poland Voivodeship, 41-400

  • Sonomed Sp. Z O.O.

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Gastromed Sp. z o.o.

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

Germany7 sites

  • Universität des Saarlandes - Innere Med. II

    Homburg, 66421

  • Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH

    Leipzig, 04103

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

    Leipzig, 04103

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

    Lübeck, 23562

  • Universitätsmedizin der JGU Mainz - Hepatologie

    Mainz, 55131

  • Universitätsklinikum Münster - Medizinische Klinik B

    Münster, 48149

  • Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

    Würzburg, 97080

Other trials in Germany

Bulgaria6 sites

  • MHAT St. Ivan Rilski Gorna Oriahovitsa EOOD

    Gorna Oryahovitsa, 5100

  • Acibadem City Clinic UMHAT Tokuda EAD, Gastroenterology

    Sofia, 1407

  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

    Sofia, 1431

  • UMHAT Sveti Ivan Rilski EAD, Gastroenterology

    Sofia, 1431

  • DCC XX - Sofia EOOD, Gastroenterology

    Sofia, 1618

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784

Other trials in Bulgaria

Canada5 sites

  • University of Calgary Liver Unit-(HMRC)

    Calgary, Alberta, T2N 4Z6

  • London Health Sciences Centre- University Hospital

    London, Ontario, N6A5A5

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • GI Research Inst Foundation

    Vancouver, British Columbia, V6Z 2K5

  • TDDA Specialty Research

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Italy5 sites

  • AOU Careggi Firenze

    Florence, Tuscany, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione Evangelica Betania - UO Epatologia

    Naples, 80147

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Roma, 00168

Other trials in Italy

Spain5 sites

  • Hospital Clinic i Provincial

    Barcelona, Catalonia, 08036

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Complejo Hospitalario de Pontevedra - Hospital de Montecelo

    Pontevedra, Galicia, 36004

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Valladolid

    Valladolid, España, 47003

Other trials in Spain

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Herlev Hospital - Gastroenterology and Hepatology, Clinic 3

    Herlev, 2730

  • Hvidovre Hospital - Gastroenheden

    Hvidovre, 2650

  • Odense University Hospital - FLASH - Centre for Liver Research

    Odense C, 5000

Other trials in Denmark

Netherlands4 sites

  • Albert Schweitzer Zkh, Dordwijk

    Dordrecht, 3318 AT

  • Erasmus MC

    Rotterdam, 3015 GD

  • ETZ Elisabeth

    Tilburg, 5022 GC

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

France3 sites

  • Centre Hospitalier Universitaire D'Angers

    Angers, 49100

  • Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez

    Lille, 59000

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Greece3 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Czechia2 sites

  • Krajská nemocice Liberec, a.s

    Liberec, 460 01

  • Vseobecna Fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

About this study

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

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.

Being tested
NNC0194-0499, Semaglutide, NNC0194-0499 placebo, Semaglutide placebo (Group A), Cagrilintide + semaglutide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0194-0499Drug

    Administered subcutaneously.

  • SemaglutideDrug

    Administered subcutaneously.

  • NNC0194-0499 placeboDrug

    Administered subcutaneously.

  • Semaglutide placebo (Group A)Drug

    Administered subcutaneously.

  • Cagrilintide + semaglutideDrug

    Administered subcutaneously.

  • CagrilintideDrug

    Administered subcutaneously.

  • Cagrilintide placeboDrug

    Administered subcutaneously.

  • Semaglutide placebo (Group B)Drug

    Administered subcutaneously.

Study groups in NCT06409130
Study groupRoleWhat they receive
NNC0194-0499 + semaglutideExperimentalGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.
Receives: Drug: NNC0194-0499; Drug: Semaglutide
NNC0194-0499 + semaglutide placeboExperimentalGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.
Receives: Drug: NNC0194-0499; Drug: Semaglutide placebo (Group A)
NNC0194-0499 placebo + semaglutideExperimentalGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.
Receives: Drug: Semaglutide; Drug: NNC0194-0499 placebo
NNC0194-0499 placebo + semaglutide placeboPlacebo comparatorGroup A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.
Receives: Drug: NNC0194-0499 placebo; Drug: Semaglutide placebo (Group A)
CagriSemaExperimentalGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.
Receives: Drug: Cagrilintide + semaglutide
Cagrilintide + semaglutide placeboExperimentalGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.
Receives: Drug: Cagrilintide; Drug: Semaglutide placebo (Group B)
Cagrilintide placebo + semaglutide placeboPlacebo comparatorGroup B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.
Receives: Drug: Cagrilintide placebo; Drug: Semaglutide placebo (Group B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Enhanced Liver Fibrosis (ELF)

    Measured as logarithm score

    Measured: From week 0 to week 28

Secondary outcomes (9)

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

    Measured as ratio to baseline

    Measured: From week 0 to week 28

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

    Measured as ratio to baseline

    Measured: From week 0 to week 28

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

    Measured as decibel milliwatts (dB/m)

    Measured: From week 0 to week 28

  4. Change in Alanine Aminotransferase (ALT)

    Measured as ratio to baseline

    Measured: From week 0 to week 28

  5. Change in Aspartate Aminotransferase (AST)

    Measured as ratio to baseline

    Measured: From week 0 to week 28

  6. Number of treatment emergent adverse events

    Measured as count of events

    Measured: From week 0 to week 35

  7. Change in Phosphatidylethanol (PEth)

    Measured as ratio to baseline

    Measured: From week -4 to week 28

  8. Change in alcohol amount measured by timeline followback (TLFB)

    Measured as grams per day

    Measured: From week -4 to week 28

  9. Change in total cholesterol

    Measured as ratio to baseline

    Measured: From week 0 to week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start20 May 2024
  3. Primary completion21 Nov 2025
  4. Study completion12 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06409130
Sponsor's protocol ID
NN9500-7730
Other IDs
U1111-1295-6713, 2023-508170-28, 2023
Status last verified
Mar 2026
First submitted
7 May 2024
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0194-0499, Semaglutide and Cagrilintide + semaglutide in people with Alcohol-related Liver Disease, run by Novo Nordisk A/S at 102 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Japan, Australia, Poland, Germany and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Enhanced Liver Fibrosis (ELF) (time frame: From week 0 to week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06409130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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