AzTrials
AzTrials

Non-alcoholic SteatohepatitisPhase 2NCT05016882

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

A Phase 2 study testing NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL and NNC0174 0833 10 mg/mL in people with Non-alcoholic Steatohepatitis, run by Novo Nordisk A/S at 255 sites in 24 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

This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non-alcoholic Steatohepatitis
What is being tested?
NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL and NNC0174 0833 10 mg/mL
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
698 participants
Where
255 sitesin 24 countries
Study dates
31 Aug 2021to 14 Mar 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Aged greater than or equal to 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged greater than or equal to 19 years. In Japan, subjects must be aged greater than or equal to 20 years. In Singapore, subjects must be aged greater than or equal to 21 years.
  • Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to Visit 1.
  • Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
  • Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.

Who cannot join

  • Documented causes of chronic liver disease other than NAFLD.
  • Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
  • Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
  • For subjects with F4, presence or history of gastro-oesophageal varices more than or equal to grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52 weeks prior to V3 must be available at V3.
  • Known or suspected excessive consumption of alcohol (more than 20 g/day for women or more than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
  • Treatment with vitamin E (at doses more than or equal to 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
  • Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
  • Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.

Trial locations and contacts

255 sites in 24 countries.

255 sites in 24 countries

United States70 sites

  • Texas Clin Res Inst, LLC

    Arlington, Texas, 76012

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30327

  • Mercy Medical Center, GI Research

    Baltimore, Maryland, 21202

  • Walter Reed Nat Mil Md Ctr

    Bethesda, Maryland, 20889

  • Hope Clinical Research

    Canoga Park, California, 91303

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • Univ Hosp Cleveland Med Ctr

    Cleveland, Ohio, 44106

  • Peak Gastro Assoc-Col Springs

    Colorado Springs, Colorado, 80907

  • Ohio State Univ Wexner Med Ctr

    Columbus, Ohio, 43210

  • Liver Ins@ Mthdist DTX Med Cen

    Dallas, Texas, 75203

  • Geisinger Clinic

    Danville, Pennsylvania, 17822-2111

  • Henry Ford Hospital_Detroit

    Detroit, Michigan, 48202

  • Integrity Clinical Research, LLC

    Doral, Florida, 33122

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • AIG Digestive Disease Research

    Florham Park, New Jersey, 07932

  • Hartford Hsptl_Hartford

    Hartford, Connecticut, 06106

  • Digestive Health Res-TSMC

    Hermitage, Tennessee, 37076

  • Pennsylvania State University

    Hershey, Pennsylvania, 17033

  • Miguel Rebollar PA

    Hialeah, Florida, 33012

  • Tandem Clinical Research - Houma

    Houma, Louisiana, 70363

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • North AL Health Res, LLC

    Huntsville, Alabama, 35801

  • Grand Teton Gastroenterology

    Idaho Falls, Idaho, 83404-7590

  • Nature Coast Clinical Research_Inverness

    Inverness, Florida, 34452

  • UF Hlth Jacksonville

    Jacksonville, Florida, 32224

  • University Of Kansas Hospital

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • UCSD NAFLD Research Center

    La Jolla, California, 92037

  • Florida Research Institute, LLC

    Lakewood Rch, Florida, 34211

  • OM Research LLC

    Lancaster, California, 93534

  • Digestive Hlth Res of SoCa

    Long Beach, California, 90808

  • Gastroenterology Assoc_ CGA

    Macon, Georgia, 31201

  • ClinCloud,LLC

    Maitland, Florida, 32751

  • Gastroint Spec of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Tandem Clinical Research - Metairie

    Metairie, Louisiana, 70006

  • Optimus U, Corp

    Miami, Florida, 33135

  • Univ of Miami/Schiff Ctr

    Miami, Florida, 33136

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • NYU Grossman School of Med

    New York, New York, 10016

  • Weill Cornell Med Coll-NYPH

    New York, New York, 10065

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Inst-Liver Hlth dba AZ Liver H

    Peoria, Arizona, 85381

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5244

  • UPMC Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • UPMC_Center for Liver Care

    Pittsburgh, Pennsylvania, 15213

  • Stanford Medicine

    Redwood City, California, 94063

  • Bon Secours Richmond Community Hospital LLC

    Richmond, Virginia, 23226

  • Gastroent Consult of SW VA

    Roanoke, Virginia, 24014

  • Texas Diabetes &Endocrinology

    Round Rock, Texas, 78681

  • UC Davis Hlth -Midtwn Ambu Cen

    Sacramento, California, 95817

  • Amer. Rrsch Corp-TX Liver Inst

    San Antonio, Texas, 78215

  • Swedish med ctr org trans-lvr ctr

    Seattle, Washington, 98104

  • Liver Institute NW

    Seattle, Washington, 98105

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • EBGS Clinical Research Center, LLC

    Snellville, Georgia, 30078

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • DSI Research,LLC

    Springboro, Ohio, 45066

  • Olympus Clinical Research

    Sugar Land, Texas, 77478

  • Kansas Medical Clinic, PA

    Topeka, Kansas, 66606

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Covenant Metabolic Specialists LLC

    University Park, Florida, 34201

  • ClinCloud, LLC

    Viera E., Florida, 32940

  • Impact Research

    Waco, Texas, 76710

  • Digestive Hlth Res of N Texas

    Wichita Falls, Texas, 76301

  • Florida Medical Clinic Orlando Health

    Zephyrhills, Florida, 33542

  • Florida Medical Clinic, LLC

    Zephyrhills, Florida, 33542

Other trials in United States

Russia32 sites

  • Volosevich First City Clinical Hospital

    Arkhangelsk, 163001

  • City Hospital #5

    Barnaul, 656045

  • Limited Liability Company "Alliance Biomedical Ural Group"

    Izhevsk, 426061

  • Kazan Federal University

    Kazan', 420012

  • LLC "Clinic of Aesthetic Medicine & Laser Technologies"

    Kazan', 420111

  • Limited Liability Company "Polyclinica № 1"

    Moscow, 117041

  • Friendship University of Russia

    Moscow, 117292

  • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

    Moscow, 117292

  • Setchenov First Moscow State Medical University

    Moscow, 119435

  • PHI "Central Clinical Hospital RZD- Medicine"

    Moscow, 125367

  • Pirogov Russian National Research Medical University MoH

    Moscow, 129226

  • LLC RC Medical

    Novosibirsk, 630005

  • RIIPM - branch of ICG SB of RAS

    Novosibirsk, 630089

  • Limited Law Company "Healthy Family" Medicine Center"

    Novosibirsk, 630099

  • LLC "Clinical diagnostic center Ultramed"

    Omsk, 644024

  • BHI of Omsk Region "City Hospital № 3"

    Omsk, 644029

  • Penza Regional Clinical Hospital named after N.N. Burdenko

    Penza, 440052

  • Joint Stock Company "Polyclinic Complex"

    Saint Petersburg, 190013

  • SPb SBHI City Outpatient clinic #109

    Saint Petersburg, 192283

  • Limited Liability Company "Clinic" MEDINEF "

    Saint Petersburg, 194044

  • Limited Liability Company "Energiya Zdoroviya"

    Saint Petersburg, 194156

  • X Seven Clinical Research Limited Liability Company

    Saint Petersburg, 194156

  • SPb SBHI City polyclinic #117

    Saint Petersburg, 194358

  • North-Western State Medical Univer. based on Med-Prof Center

    Saint Petersburg, 195067

  • Medical Research Institute LLC

    Saint Petersburg, 196084

  • Limited Liability Company "Research Center Eco-safety"

    Saint Petersburg, 196143

  • Private medical institution "Euromedservice"

    Saint Petersburg, 196603

  • Consultative & Diagnostic Center with a Outpatient Hospital

    Saint Petersburg, 197110

  • Siberian State Medical University

    Tomsk, 634050

  • Ulianovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • Joint Stock Company "Medical technologies"

    Yekaterinburg, 620075

  • Polyclinic #2 in Yoshkar-Ola

    Yoshkar-Ola, 424004

Other trials in Russia

India18 sites

  • KLES & Prabhakar Kore Hospital and Research Centre

    Belagavi, Karnatka, 590010

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    Chandigarh, Punjab, 160012

  • Fortis Heart Institute and Multispeciality Hospital

    Chandigarh,, Punjab, 160062

  • Institute of liver and Biliary Sciences

    Ghitorni, New Delhi, 110070

  • Medanta - The Medicity Multi-Speciality Hospital, Gurugram

    Gurugram, Haryana, 122001

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Dr P V Rao - Diabetes Research Centre

    Hyderabad, Telangana, 50082

  • S.R.Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab, 141001

  • Kasturba Medical College Hospitals (KMC Hospitals), Mangalore

    Mangalore, Karnataka, 575001

  • Gleneagles Hospital, Super-speciality and Transplant Centre, Parel

    Mumbai, Maharashtra, 400012

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Midas Multispeciality Hospital

    Nagpur, Maharashtra, 441108

  • All India Institute of medical Sciences

    New Dehli, New Delhi, 110029

  • Yashoda Hospital

    Secunderabad, Andhra Pradesh, 500003

  • Surat Institute of Digestive Science

    Surat, Gujarat, 395002

  • BAPS Pramukh Swami Hospital

    Surat, Gujarat, 395009

Other trials in India

Japan17 sites

  • Chiba University Hospital_Chiba-shi, Chiba

    Chiba-shi, Chiba, 260-8677

  • Fukui-ken Saiseikai Hospital, Internal Medicine

    Fukui-shi, Fukui, 918-8503

  • Hamamatsu University Hospital

    Hamamatsu-shi, Shizuoka, 431-3192

  • JA Hiroshima General Hospital_Gastroenterology and Hepatology

    Hatsukaichi-shi, Hiroshima, 783-8503

  • University Hospital Kyoto Prefectual University of Medicine

    Kamigyo-ku, Kyoto, 602-8566

  • St. Marianna University School of Medicine Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Kumamoto Shinto General Hospital_Liver・Gastroenterology

    Kumamoto-shi, Kumamoto, 862-8655

  • Toranomon Hospital, Hepatology

    Minato-ku, Tokyo, 105-8470

  • Kawasaki Medical School General Medical Center_Internal Medicine

    Okayama-shi, Okayama, 700-8505

  • Saga University Hospital_Liver Center

    Saga-shi, Saga, 849-8501

  • Sendai Kousei Hospital

    Sendai-shi, Miyagi, 981-0914

  • Saiseikai Suita Hospital, Gastroenterology

    Suita-shi, Osaka, 564-0013

  • Ehime University Hospital_Department of Gastro.& Metabo.

    Toon-shi, Ehime, 791-0295

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

  • Saiseikai Wakayama Hospital_Gastroenterology

    Wakayama-shi, Wakayama, 640-8158

  • Saiseikai Wakayama Hospital

    Wakayama-shi, Wakayama, 640-8158

  • Yokohama City University Hospital, Gastrointestinal Medicine

    Yokohama-shi, Kanagawa, 236-0004

Other trials in Japan

Poland11 sites

  • Spolka Lekarzy Intercor Sp. z o.o.

    Bydgoszcz, 85-605

  • Clinical Medical Research Korfantego - Ambulatoryjna Opieka

    Katowice, 40-156

  • Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śl

    Katowice, 40-752

  • "LANDA" Katarzyna Agata Landa

    Krakow, 31-156

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

  • ID Clinic Arkadiusz Pisula

    Myslowice, Lesser Poland Voivodeship, 41-400

  • Centrum Medyczne Medyk Sp. z o.o.

    Rzeszów, 35-326

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • EMC Instytut Medyczny S.A.

    Wroclaw, 50-220

  • Centrum Badan Klinicznych

    Wroclaw, 51-162

  • FutureMeds Sp. z o.o.

    Wroclaw, 53-673

Other trials in Poland

Australia10 sites

  • Royal Adelaide Hospital - Hepatology- 5E291

    Adelaide, South Australia, 5000

  • Genesis Research Services

    Broadmeadow, New South Wales, 2292

  • Monash Health Department of Gastroenterology

    Clayton, Victoria, 3168

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3084

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • The Alfred Centre - Gastroenterology

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital - Hepatology

    Murdoch, Western Australia, 6150

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea10 sites

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 15355

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam Univ. Medical Center

    Daegu, 42415

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Wonju Severance Christian Hospital

    Gangwon-do, 26426

  • SoonChunHyang University Hospital Bucheon

    Gyeonggi-do, 14584

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Chung-Ang University Hospital

    Seoul, 06973

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Hacettepe Universitesi Tıp Fakültesi- Gastroenteroloji

    Ankara, 06230

  • Gazi University Medical Faculty

    Ankara, 06500

  • Gaziantep Üniversitesi Hastanesi

    Gaziantep, 27070

  • Bezmialem Vakıf Üniversitesi Hastanesi-Gastroenteroloji

    Istanbul, 34093

  • Cerrahpasa Kardiyoloji Enstitüsü

    Istanbul, 34098

  • Marmara Univ. Pendik Gastroenterology

    Istanbul, 34899

  • Kocaeli Universitesi Tıp Fakültesi Gastroenteroloji ve Hepat

    Kocaeli, 41000

  • Recep Tayyip Erdoğan Üniversitesi EAH-Endokrinoloji

    Rize, 53020

  • Adana Şehir Eğitim ve Araştırma Hastanesi

    Yüreğir/Adana, 1370

Other trials in Turkey (Türkiye)

Bulgaria8 sites

  • MHAT - UniHospital OOD

    Panagyurishte, 4500

  • MHAT Med Line Clinic

    Plovdiv, 4000

  • "Acibadem City Clinic UMHAT Tokuda"

    Sofia, 1407

  • DCC Aleksandrovska EOOD

    Sofia, 1431

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

    Sofia, 1431

  • Medical Center Vertebra OOD

    Sofia, 1504

  • "UMHAT "Tsaritsa Yoanna-ISUL"" EAD, Gastroenterology clinic

    Sofia, 1527

  • "DCC XX - Sofia" EOOD

    Sofia, 1618

Other trials in Bulgaria

France8 sites

  • Centre Hospitalier Universitaire D'Angers-1

    Angers, 49100

  • Ap-Hp-Hopital Beaujon

    Clichy, 92110

  • Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez

    Lille, 59037

  • Hospices Civils de Lyon-Hopital de La Croix Rousse

    Lyon, 69317

  • Centre Hospitalier Universitaire de Nice-Hopital de L'Archet 2

    Nice, 06200

  • Aphp-Hopital La Pitie Salpetriere-4

    Paris, 75013

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

    Saint-Herblain, 44800

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Italy8 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

    Bergamo, 24127

  • Azieda Ospedaliero-Universitaria, Policlinico S. Orsola-Malp

    Bologna, 40138

  • AOU Careggi Padiglione 16 San Luca, 3° piano

    Florence, 50134

  • Azienda Ospedaliera di Padova Clin.Med.3

    Padova, 35128

  • AOU Pisana Stabilimento di Cisanello EDIFICIO 6, Piano 5

    Pisa, 56124

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Roma, 00168

  • Policlinico Università Campus Biomedico di Roma

    Rome, 00128

Other trials in Italy

Canada7 sites

  • University of Calgary Liver Unit-(HMRC)

    Calgary, Alberta, T2N 4Z6

  • QE II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • LMC Manna Research Inc. (London)

    London, Ontario, N6A 2C2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • GI Research Inst Foundation

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Germany7 sites

  • Klinik für Endokrinologie, Diabetologie und Stoffwechsel

    Essen, 45147

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

    Lübeck, 23538

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23562

  • Universitätsmedizin der JGU Mainz - Hepatologie

    Mainz, 55131

  • Uniklinik Tübingen - Innere Medizin I

    Tübingen, 72076

  • Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)

    Würzburg, 97080

  • Universitätsklinikum Würzburg, ZIM

    Würzburg, 97080

Other trials in Germany

Greece6 sites

  • Gen Hospital of Athens Ippokrateio,B' Uni Clinic of Inte Med

    Athens, 11527

  • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

    Athens, 11527

  • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

    Athens, GR-11527

  • General Hospital of Athens "LAIKO"

    Goudi, Athens, 115 27

  • "AHEPA" University Hospital of Thessaloniki

    Thessaloniki, 54621

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642

Other trials in Greece

Spain6 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Complejo Hospitalario de Pontevedra - Hospital de Montecelo

    Pontevedra, Galicia, 36004

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Clínico de Valladolid

    Valladolid, 47003

Other trials in Spain

Belgium4 sites

  • CUB Hôpital Erasme_Brussels_0

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology

    Brussels, 1200

  • UZA

    Edegem, 2650

  • UZ Gent - Department Gastro-enterology

    Ghent, 9000

Other trials in Belgium

Singapore4 sites

  • National University Hospital_Tahir Building

    Singapore, 119228

  • National University Hospital_TBD

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Taiwan4 sites

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 600

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital_main

    Taipei, 100

Other trials in Taiwan

Czechia3 sites

  • Krajská nemocice Liberec, a.s

    Liberec, 460 01

  • Fakultni nemocnice Plzen - Lochotin

    Pilsen, 301 00

  • Vseobecna Fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Denmark3 sites

  • Hvidovre Hospital - Gastroenheden

    Hvidovre, 2650

  • Abdominal Center K, Research Unit

    København NV, 2400

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

Malaysia3 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan, 16150

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Portugal3 sites

  • Unidade Local De Saude De Santa Maria E.P.E.

    Lisbon, 1649-035

  • Unidade Local De Saude De Matosinhos E.P.E.

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513

  • Hospital Luz Arrabida, S.A.

    Vila Nova de Gaia, 4400-346

Other trials in Portugal

United Kingdom3 sites

  • Queen Elizabeth Hospital, Birmingham

    Birmingham, B15 2TH

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Imperial College London

    London, W2 1NY

Other trials in United Kingdom

Puerto Rico1 site

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).

NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.

Read more

The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.

Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.

The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.

Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.

Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Being tested
NNC0194 0499 50 mg/mL, Placebo (NNC0194-0499), Semaglutide 3 mg/mL, Semaglutide placebo, NNC0174 0833 10 mg/mL
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

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

  • NNC0194 0499 50 mg/mLDrug

    Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months

  • Placebo (NNC0194-0499)Drug

    Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months

  • Semaglutide 3 mg/mLDrug

    Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months

  • Semaglutide placeboDrug

    Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months

  • NNC0174 0833 10 mg/mLDrug

    Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months

  • NNC0174 0833 placeboDrug

    Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months

Study groups in NCT05016882
Study groupRoleWhat they receive
NNC0194-0499 7.5 mg + semaglutide 2.4 mgExperimentalEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: NNC0194 0499 50 mg/mL; Drug: Semaglutide 3 mg/mL
Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mgPlacebo comparatorEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Placebo (NNC0194-0499); Drug: Semaglutide placebo
NNC0194-0499 15 mg + semaglutide 2.4 mgExperimentalEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: NNC0194 0499 50 mg/mL; Drug: Semaglutide 3 mg/mL
Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mgPlacebo comparatorEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Placebo (NNC0194-0499); Drug: Semaglutide placebo
NNC0194-0499 30 mg + semaglutide 2.4 mgExperimentalEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: NNC0194 0499 50 mg/mL
NNC0194-0499 30 mg + semaglutide placebo 2.4 mgExperimentalEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: NNC0194 0499 50 mg/mL; Drug: Semaglutide placebo
Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mgActive comparatorEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Placebo (NNC0194-0499); Drug: Semaglutide 3 mg/mL
Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mgPlacebo comparatorEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Placebo (NNC0194-0499); Drug: Semaglutide placebo
NNC0174-0833 2.4 mg + semaglutide 2.4 mgExperimentalEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Semaglutide 3 mg/mL; Drug: NNC0174 0833 10 mg/mL
Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mgPlacebo comparatorEach subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.
Receives: Drug: Semaglutide placebo; Drug: NNC0174 0833 placebo

What is being measured

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

  1. Improvement in liver fibrosis and no worsening of NASH (Yes/No)

    Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale

    Measured: From baseline (week 0) to week 52

Secondary outcomes (24)

  1. Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)

    Count of subjects Resolution of steatohepatitis is defined as a NAS of 0-1 for inflammation, 0 for ballooning and any value for steatosis according to NASH CRN52. Fibrosis is graded on the NASH CRN (Non-Alcoholic Steatohepatitis Clinical Research Network) fibrosis scale from 0 to 4.

    Measured: From baseline (week 0) to week 52

  2. Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)

    Count of subjects The 2-point reduction must include at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning.

    Measured: From baseline (week 0) to week 52

  3. Change in histology-assessed liver collagen proportionate area

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  4. Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)

    Count of subjects Resolution of steatohepatitis is defined as an NAS score of 0-1 for inflammation, 0 for ballooning and any value for steatosis (according to NASH CRN).

    Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale

    Measured: From baseline (week 0) to week 52

  5. Improvement in liver fibrosis (Yes/No)

    Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale

    Measured: From baseline (week 0) to week 52

  6. Progression of liver fibrosis (Yes/No)

    Count of subjects For subjects with fibrosis stage 2 or 3 at baseline

    Measured: From baseline (week 0) to week 52

  7. Worsening in steatohepatitis (Yes/No)

    Count of subjects Worsening in steatohepatitis is defined as increase in NAS score for ballooning, inflammation or steatosis

    Measured: From baseline (week 0) to week 52

  8. Improvement in ballooning (Yes/No)

    Count of subjects

    Measured: From baseline (week 0) to week 52

  9. Improvement in inflammation (Yes/No)

    Count of subjects

    Measured: From baseline (week 0) to week 52

  10. Improvement in steatosis (Yes/No)

    Count of subjects

    Measured: From baseline (week 0) to week 52

  11. Change in ALT (alanine aminotransferase)

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  12. Change in AST (aspartate aminotransferase)

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  13. Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  14. Change in ELF (Enhanced Liver Fibrosis) score

    Logarithm

    Measured: From baseline (week 0) to week 52

  15. Change in HbA1c. For subjects with type 2 diabetes

    %-points (absolute change)

    Measured: From baseline (week 0) to week 52

  16. Change in triglycerides

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  17. Change in free fatty acids

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  18. Change in LDL (low density lipoprotein) cholesterol

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  19. Change in HDL (high density lipoprotein) cholesterol

    Ratio to baseline

    Measured: From baseline (week 0) to week 52

  20. Relative change in body weight

    Percentage

    Measured: From baseline (week 0) to week 52

  21. Change in SF-36 (36-item Short Form Survey) bodily pain

    Points

    Measured: From baseline (week 0) to week 52

  22. Change in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)pain

    Points

    Measured: From baseline (week 0) to week 52

  23. Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score

    Points

    Measured: From baseline (week 0) to week 52

  24. Number of treatment emergent adverse events (TEAEs)

    Count

    Measured: From baseline (week 0) to week 59

Timeline

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

  1. First posted23 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion17 Dec 2024
  4. Study completion14 Mar 2025

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
Model description
This is a randomised, double-blind, active and placebo-controlled, double-dummy, parallel group, multinational trial investigating NNC0194-0499 at 3 different dose levels when co administered with semaglutide
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
698 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016882
Sponsor's protocol ID
NN9500-4656
Other IDs
U1111-1255-5551, 2020-003566-39
Status last verified
Nov 2025
First submitted
18 Aug 2021
Last updated
19 Nov 2025
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

Publications

  • Loomba R, George J, Castera L, Francque S, Lawitz E, Shoeb A, Clausen JO, Andersen B, Larsen AB, Gluud LL. Efficacy and safety of zalfermin co-administered with semaglutide in participants with fibrosis and cirrhosis due to metabolic dysfunction-associated steatohepatitis: a phase 2, dose-ranging, double-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Sep;11(9):797-811. doi: 10.1016/S2468-1253(26)00123-8. Epub 2026 Jul 15.

    PubMed 42456707

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL and NNC0174 0833 10 mg/mL in people with Non-alcoholic Steatohepatitis, run by Novo Nordisk A/S at 255 sites in 24 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 8 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 255 sites in United States, Russia, India, Japan, Poland and 19 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?

Improvement in liver fibrosis and no worsening of NASH (Yes/No) (time frame: From baseline (week 0) to week 52). 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 NCT05016882, which also lists 1 linked publication.

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 19 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in