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

PHASE2CompletedINTERVENTIONAL
Enrollment

698

Participants

Timeline

Start Date

August 31, 2021

Primary Completion Date

December 17, 2024

Study Completion Date

March 14, 2025

Conditions
Non-alcoholic Steatohepatitis
Interventions
DRUG

NNC0194 0499 50 mg/mL

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

DRUG

Placebo (NNC0194-0499)

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

DRUG

Semaglutide 3 mg/mL

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

DRUG

Semaglutide placebo

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

DRUG

NNC0174 0833 10 mg/mL

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

DRUG

NNC0174 0833 placebo

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

Trial Locations (185)

100

National Taiwan University Hospital_main, Taipei

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1070

CUB Hôpital Erasme_Brussels_0, Brussels

1200

Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology, Brussels

1407

"Acibadem City Clinic UMHAT Tokuda", Sofia

1431

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

1618

"DCC XX - Sofia EOOD", Sofia

2010

St Vincent's Hospital, Darlinghurst

2145

Westmead Hospital, Westmead

2400

Abdominal Center K, Research Unit, København NV

2650

UZA, Edegem

Hvidovre Hospital - Gastroenheden, Hvidovre

2747

Nepean Hospital, Kingswood

3004

The Alfred Centre - Gastroenterology, Melbourne

3065

St Vincent's Hospital (Melbourne), Fitzroy

3084

Austin Health, Heidelberg

3168

Monash Health Department of Gastroenterology, Clayton

5000

Royal Adelaide Hospital - Hepatology- 5E291, Adelaide

Odense University Hospital, Odense C

6150

Fiona Stanley Hospital - Hepatology, Murdoch

9000

UZ Gent - Department Gastro-enterology, Ghent

10016

NYU Grossman School of Med, New York

10065

Weill Cornell Med Coll-NYPH, New York

11527

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

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

15213

UPMC Center for Liver Diseases, Pittsburgh

UPMC_Center for Liver Care, Pittsburgh

15355

Korea University Ansan Hospital, Ansan

16150

Hospital Universiti Sains Malaysia, Kota Bharu

17033

Pennsylvania State University, Hershey

19104

University of Pennsylvania Hospital, Philadelphia

20889

Walter Reed Nat Mil Md Ctr, Bethesda

21202

Mercy Medical Center, GI Research, Baltimore

22042

Inova Fairfax Medical Campus, Falls Church

23226

Bon Secours Richmond Community Hospital LLC, Richmond

23538

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

23562

Universitätsklinikum Schleswig-Holstein, Lübeck

24014

Gastroent Consult of SW VA, Roanoke

24127

Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII, Bergamo

26426

Wonju Severance Christian Hospital, Gangwon-do

30060

Gastroint Spec of Georgia, Marietta

30309

Piedmont Healthcare, Atlanta

30327

Digestive Healthcare of Georgia, Atlanta

31201

Gastroenterology Assoc_ CGA, Macon

32224

UF Hlth Jacksonville, Jacksonville

33012

Miguel Rebollar PA, Hialeah

33122

Integrity Clinical Research, LLC, Doral

33135

Optimus U, Corp, Miami

33136

Univ of Miami/Schiff Ctr, Miami

33542

Florida Medical Clinic Orlando Health, Zephyrhills

Florida Medical Clinic, LLC, Zephyrhills

34093

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi-Gastroe, Istanbul

34201

Covenant Metabolic Specialists LLC, University Park

34211

Florida Research Institute, LLC, Lakewood Rch

34452

Nature Coast Clinical Research_Inverness, Inverness

34899

Marmara Univ. Pendik Gastroenterology, Istanbul

35128

Azienda Ospedaliera di Padova Clin.Med.3, Padua

35801

North AL Health Res, LLC, Huntsville

36004

Complejo Hospitalario de Pontevedra - Hospital de Montecelo, Pontevedra

37076

Digestive Health Res-TSMC, Hermitage

37211

Quality Medical Research, Nashville

39008

Hospital Universitario Marqués de Valdecilla, Santander

40138

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

41000

Kocaeli Universitesi Tıp Fakültesi Gastroenteroloji ve Hepat, Kocaeli

41013

Hospital Virgen del Rocío, Seville

41944

Kyungpook National University Hospital, Daegu

42415

Yeungnam Univ. Medical Center, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

43210

Ohio State Univ Wexner Med Ctr, Columbus

44106

Univ Hosp Cleveland Med Ctr, Cleveland

44800

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, Saint-Herblain

45066

DSI Research,LLC, Springboro

45147

Klinik für Endokrinologie, Diabetologie und Stoffwechsel, Essen

46635

Digestive Research Alliance of Michiana, South Bend

47003

Hospital Clínico de Valladolid, Valladolid

48202

Henry Ford Hospital_Detroit, Detroit

49100

Centre Hospitalier Universitaire D'Angers-1, Angers

50082

Dr P V Rao - Diabetes Research Centre, Hyderabad

50134

AOU Careggi Padiglione 16 San Luca, 3° piano, Florence

54621

"AHEPA University Hospital of Thessaloniki", Thessaloniki

54642

"General Hospital of Thessaloniki Ippokrateio", Thessaloniki

55131

Universitätsmedizin der JGU Mainz - Hepatologie, Mainz

56124

AOU Pisana Stabilimento di Cisanello EDIFICIO 6, Piano 5, Pisa

59100

University Malaya Medical Centre, Lembah Pantai

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

64131

Kansas City Research Institute, Kansas City

66160

University Of Kansas Hospital, Kansas City

66606

Kansas Medical Clinic, PA, Topeka

68100

Hospital Selayang, Batu Caves

69200

Centre de Recherche Clinique Portes Du Sud, Vénissieux

69317

Hospices Civils de Lyon-Hopital de La Croix Rousse, Lyon

70072

Tandem Clinical Research, Marrero

70363

Tandem Clinical Research - Houma, Houma

71105

Louisiana Research Center, LLC, Shreveport

75013

Aphp-Hopital La Pitie Salpetriere-4, Paris

75203

Liver Ins@ Mthdist DTX Med Cen, Dallas

76012

Texas Clin Res Inst, LLC, Arlington

76301

Digestive Hlth Res of N Texas, Wichita Falls

76710

Impact Research, Waco

77478

Olympus Clinical Research, Sugar Land

78215

Amer. Rrsch Corp-TX Liver Inst, San Antonio

78681

Texas Diabetes &Endocrinology, Round Rock

80907

Peak Gastro Assoc-Col Springs, Colorado Springs

85224

The Institute for Liver Health, Chandler

85381

Inst-Liver Hlth dba AZ Liver H, Peoria

85715

Del Sol Research Management, LLC, Tucson

92037

UCSD NAFLD Research Center, La Jolla

92110

Ap-Hp-Hopital Beaujon, Clichy

93534

OM Research LLC, Lancaster

94063

Stanford Medicine, Redwood City

95817

UC Davis Hlth -Midtwn Ambu Cen, Sacramento

97080

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

Universitätsklinikum Würzburg, ZIM, Würzburg

98104

Swedish med ctr org trans-lvr ctr, Seattle

98105

Liver Institute NW, Seattle

110029

All India Institute of medical Sciences, New Dehli

110070

Institute of liver and Biliary Sciences, Ghitorni

119228

National University Hospital_Tahir Building, Singapore

National University Hospital_TBD, Singapore

122001

Medanta - The Medicity Multi-Speciality Hospital, Gurugram, Gurugram

160012

Post Graduate Institute of Medical Education & Research_Chandigarh, Chandigarh

160062

Fortis Heart Institute and Multispeciality Hospital, Chandigarh,

169608

Singapore General Hospital, Singapore

302001

S.R.Kalla Memorial Gastro & General Hospital, Jaipur

395002

Surat Institute of Digestive Science, Surat

395009

BAPS Pramukh Swami Hospital, Surat

400012

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

Seth GS medical college and KEM Hospital, Mumbai

440052

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

441108

Midas Multispeciality Hospital, Nagpur

500003

Yashoda Hospital, Secunderabad

500012

Osmania General Hospital, Hyderabad

529889

Changi General Hospital, Singapore

575001

Kasturba Medical College Hospitals (KMC Hospitals), Mangalore, Mangalore

06106

Hartford Hsptl_Hartford, Hartford

07932

AIG Digestive Disease Research, Florham Park

17822-2111

Geisinger Clinic, Danville

19107-5244

Thomas Jefferson University Hospital, Philadelphia

T2N 4Z6

University of Calgary Liver Unit-(HMRC), Calgary

V6Z 2K5

GI Research Inst Foundation, Vancouver

M6H 3M1

Toronto Liver Centre, Toronto

460 01

Krajská nemocice Liberec, a.s, Liberec

06200

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

GR-11527

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

115 27

"General Hospital of Athens LAIKO", Goudi, Athens

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCS, Roma

00128

Policlinico Università Campus Biomedico di Roma, Rome

260-8677

Chiba University Hospital_Chiba-shi, Chiba, Chiba-shi, Chiba

918-8503

Fukui-ken Saiseikai Hospital, Internal Medicine, Fukui-shi, Fukui

431-3192

Hamamatsu University Hospital, Hamamatsu-shi, Shizuoka

783-8503

JA Hiroshima General Hospital_Gastroenterology and Hepatology, Hatsukaichi-shi, Hiroshima

602-8566

University Hospital Kyoto Prefectual University of Medicine, Kamigyo-ku, Kyoto

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki-shi, Kanagawa

862-8655

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

105-8470

Toranomon Hospital, Hepatology, Minato-ku, Tokyo

700-8505

Kawasaki Medical School General Medical Center_Internal Medicine, Okayama-shi, Okayama

849-8501

Saga University Hospital_Liver Center, Saga-shi, Saga

981-0914

Sendai Kousei Hospital, Sendai-shi, Miyagi

564-0013

Saiseikai Suita Hospital, Gastroenterology, Suita-shi, Osaka

791-0295

Ehime University Hospital_Department of Gastro.& Metabo., Toon-shi, Ehime

Ehime University Hospital, Toon-shi, Ehime

640-8158

Saiseikai Wakayama Hospital_Gastroenterology, Wakayama-shi, Wakayama

Saiseikai Wakayama Hospital, Wakayama-shi, Wakayama

236-0004

Yokohama City University Hospital, Gastrointestinal Medicine, Yokohama-shi, Kanagawa

41-400

ID Clinic Arkadiusz Pisula, Myslowice

85-605

Spolka Lekarzy Intercor Sp. z o.o., Bydgoszcz

40-156

Clinical Medical Research Korfantego - Ambulatoryjna Opieka, Katowice

40-752

Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śl, Katowice

31-156

"LANDA Katarzyna Agata Landa", Krakow

31-501

Krakowskie Centrum Medyczne Sp. z o.o., Krakow

50-220

EMC Instytut Medyczny S.A., Wroclaw

51-162

Centrum Badan Klinicznych, Wroclaw

53-673

FutureMeds Sp. z o.o., Wroclaw

4464-513

Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos

1649-035

Unidade Local De Saude De Santa Maria E.P.E., Lisbon

00927

FDI Clinical Research, San Juan

03722

Severance Hospital, Yonsei University Health System, Seoul

07061

SMG-SNU Boramae Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

01000

T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan, Adana

06230

Hacettepe Universitesi Tıp Fakültesi- Gastroenteroloji, Ankara

06500

Gazi University Medical Faculty, Ankara

EX2 5DW

Royal Devon & Exeter NHS Foundation Trust, Exeter

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT05016882 - Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) | Biotech Hunter | Biotech Hunter