A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

PHASE2CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

April 27, 2021

Primary Completion Date

November 9, 2023

Study Completion Date

December 21, 2023

Conditions
Non-alcoholic Steatohepatitis (NASH)
Interventions
DRUG

Survodutide

Survodutide

DRUG

Placebo

Placebo

Trial Locations (154)

333

Chang Gung Memorial Hospital(Linkou), Taoyuan

704

National Chen Kung University, Dept of Neurology, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1010

New Zealand Clinical Research (NZCR), Auckland

1036

Synexus Hungary Healthcare Service Ltd., Budapest

1097

Fed.St. Istvan&Szent Laszlo Hospital, Budapest

2025

Middlemore Clinical Trials, Papatoetoe

2650

Edegem - UNIV UZ Antwerpen, Edegem

3050

Royal Melbourne Hospital, Parkville

3168

Monash Medical Centre, Clayton

4215

Gold Coast University Hospital, Southport

5700

Synexus Hungary Healthcare Service Ltd, Gyula

8036

Medical University of Graz State Hospital - University Hospital Graz, Graz

10126

AO Città della Salute e Scienza, Torino

12462

Attikon University Hospital, Haidari-Athens

12627

Synexus Clinical Research GmbH, Berlin

16150

Universiti Sains Malaysia Hospital, Kelantan

20089

Istituto Clinico Humanitas, Rozzano (MI)

22100

Western Galilee Hospital, Nahariya

22400

ETG Zamosc, Zamość

23298

Virginia Commonwealth University, Richmond

28027

Northeast GI Research Division, Concord

28222

Hospital Puerta de Hierro, Majadahonda

28557

Lucas Research, Inc., Morehead City

29485

Palmetto Clinical Research, Summerville

29646

Digestive Diseases Research Center, Greenwood

30060

Gastrointestinal Specialists of Georgia, Marietta

30688

University Hospital in Krakow, Krakow

32600

Medicome Limited Liability Company, Oświęcim

32808

Omega Research Orlando, LLC, Orlando

33135

Optimus U Corporation, Miami

33157

Sanchez Clinical Research ,Inc, Miami

33166

Integrity Clinical Research, LLC, Doral

33604

HOP Haut-Lévêque, Pessac

33912

Covenant Metabolic Specialists, LLC, Fort Myers

34240

Covenant Metabolic Specialists, LLC, Sarasota

34471

Ocala GI Research, Ocala

35801

North Alabama Health Research, LLC, Huntsville

36071

Hospital de Montecelo, Pontevedra

37076

Digestive Health Research, LLC, Hermitage

39008

Hospital Universitario Marqués de Valdecilla, Santander

39232

Gastrointestinal Associates, Flowood

39532

National Diabetes and Obesity Research Institute, Biloxi

40225

Universitätsklinikum Düsseldorf, Düsseldorf

41013

Hospital Virgen del Rocío, Seville

41126

Ospedale Civile di Baggiovara, Baggiovara (MO)

42202

Synexus Poland, Branch in Czestochowa, Częstochowa

42601

Keimyung University Dongsan Hospital, Daegu

44892

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Bochum

46014

Hospital General Universitario de Valencia, Valencia

46635

Digestive Research Alliance of Michiana, South Bend

49100

Rabin Medical Center Beilinson, Petah Tikva

49241

Pusan National Univ. Hosp, Busan

52074

Universitätsklinikum Aachen, AöR, Aachen

52242

University of Iowa Hospitals and Clinics, Iowa City

54642

"General Hospital of Thessaloniki Hippokrateio", Thessaloniki

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

59100

University of Malaya Medical Centre, Kuala Lumpur

60002

Chia Yi Christian Hospital, Chiayi City

60313

Synexus Clinical Research GmbH, Frankfurt

64239

Sourasky Medical Center, Tel Aviv

67091

HOP Civil, Strasbourg

68100

Hospital Selayang, Kuala Selangor

68167

Universitätsklinikum Mannheim GmbH, Mannheim

70072

Tandem Clinical Research, Marrero

70601

Centex Studies, Inc., Lake Charles

71013

"IRCCS Ospedale Casa Sollievo della Sofferenza", SAN Giovanni Rotondo (FG)

71220

Delta Research Partners, LLC, Bastrop

75651

HOP La Pitié Salpêtrière, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

77030

Houston Methodist Hospital, Houston

78215

American Research Corporation at the Texas Liver Institute, San Antonio

78229

Pinnacle Clinical Research, San Antonio

78520

South Texas Research Institute, Brownsville

78539

South Texas Research Institute, Edinburg

78757

Texas Liver Institute, Austin

80907

Peak Gastroenterology Associates, Colorado Springs

89081

Universitätsklinikum Ulm, Ulm

90127

"A.O. Univ. Policlinico Paolo Giaccone", Palermo

90255

Velocity Clinical Research, Huntington Park

91402

Velocity Clinical Research, Panorama City

92118

Southern California Research Center, Coronado

94115

Quest Clinical Research, San Francisco

100015

Beijing Ditan Hospital Capital Medical University, Beijing

100044

Beijing Tsinghua Changgung Hospital, Beijing

Peking University People's Hospital, Beijing

100050

Beijing Friendship Hospital, Beijing

119074

National University Hospital, Singapore

130021

The First Hospital of Jilin University, Changchun

168753

Singapore General Hospital, Singapore

201508

Shanghai Public Health Clinical Center, Shanghai

210003

The Second Hospital of Nanjing, Nanjing

300170

Tianjin Third Central Hospital, Tianjin

310016

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou

325000

The First Affiliated Hospital of Wenzhou Med College, Wenxzhou

510080

The First Afiliated Hospital, Sun Yet-sen University, Guangzhou

510515

NanFang Hosptial, Guangzhou

650032

First People's hospital of Yunann Province, Kunming

999077

Prince of Wales Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

5265601

The Chaim Sheba Medical Center, Tel Litwinsky

9103102

Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem

02721

NECCR PrimaCare Research, LLC, Fall River

07932

AIG Digestive Disease Research, Florham Park

A-6020

Medical University of Innsbruck, Innsbruck

A-4010

Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz

N6A 5A5

University Hospital (LHSC), London

M6H 3M1

Toronto Liver Centre, Toronto

G7H 7K9

Ecogene-21, Chicoutimi

460 63

Regional Hospital Liberec, Liberec

128 08

General Faculty Hospital, Prague, Prague

06200

HOP l'Archet, Nice

04103

Synexus Clinical Research GmbH, Leipzig

00195

Poli Univ A. Gemelli, Roma

791-0295

Ehime University Hospital, Ehime, Toon

918-8503

Fukuiken Saiseikai Hospital, Fukui, Fukui

830-0011

Kurume University Hospital, Fukuoka, Kurume

503-8502

Ogaki Municipal Hospital, Gifu, Ogaki

062-8618

Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Sapporo

761-0793

Kagawa University Hospital, Kagawa, Kita-gun

760-8557

Kagawa Prefectural Central Hospital, Kagawa, Takamatsu

216-8511

St. Marianna University Hospital, Kanagawa, Kawasaki

252-0375

Kitasato University Hospital, Kanagawa, Sagamihara

236-0004

Yokohama City University Hospital, Kanagawa, Yokohama

245-8575

National Hospital Organization Yokohama Medical Center, Kanagawa, Yokohama

860-8556

Kumamoto University Hospital, Kumamoto, Kumamoto

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto, Kyoto

390-8621

Shinshu University Hospital, Nagano, Matsumoto

381-8551

Nagano Municipal Hospital, Nagano, Nagano

634-8522

Nara Medical University Hospital, Nara, Kashihara

564-0013

Suita Hospital, Osaka, Suita

849-8501

Saga University Hospital, Saga, Saga

431-3192

Hamamatsu University Hospital, Shizuoka, Hamamatsu

410-2295

Juntendo University Shizuoka Hospital, Shizuoka, Izunokuni

113-8519

Tokyo Medical and Dental University Hospital, Tokyo, Bunkyo-ku

1105 AZ

Amsterdam UMC, location VUMC, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum (LUMC), Leiden

3045 PM

Sint Franciscus, Locatie Vlietland, Rotterdam

85-605

INTERCORE Medical Center, Bydgoszcz

82-300

"Private health care facility Your Health EL LLC", Elblag

80-382

Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk, Gdansk

81-384

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia, Gdynia

40-752

University Clinical Center Professor Gibinskiego, Katowice

01-192

Centrum Medyczne Synexus, Warsaw

50-088

Synexus Poland, Branch in Wroclaw, Wroclaw

1649-035

ULS de Santa Maria, E.P.E, Lisbon

4202-451

Centro Hospitalar Universitário São João,EPE, Porto

03080

Seoul National University Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

B15 2TH

Queen Elizabeth Hospital, Birmingham

NE46 1QJ

Synexus - Hexham, Hexham

L9 7AL

Aintree University Hospital, Liverpool

SE5 9RS

King's College Hospital, London

NG7 2RD

Queen's Medical Centre, Nottingham

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT04771273 - A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) | Biotech Hunter | Biotech Hunter