Clinical trial NCT05016882: Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 698
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Improvement in liver fibrosis and no worsening of NASH (Yes/No)
timeFrame: From baseline (week 0) to week 52
Secondary outcomes:
measure: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Change in histology-assessed liver collagen proportionate area
timeFrame: From baseline (week 0) to week 52
measure: Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Improvement in liver fibrosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Progression of liver fibrosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Worsening in steatohepatitis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Improvement in ballooning (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Improvement in inflammation (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Improvement in steatosis (Yes/No)
timeFrame: From baseline (week 0) to week 52
measure: Change in ALT (alanine aminotransferase)
timeFrame: From baseline (week 0) to week 52
measure: Change in AST (aspartate aminotransferase)
timeFrame: From baseline (week 0) to week 52
measure: Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)
timeFrame: From baseline (week 0) to week 52
measure: Change in ELF (Enhanced Liver Fibrosis) score
timeFrame: From baseline (week 0) to week 52
measure: Change in HbA1c. For subjects with type 2 diabetes
timeFrame: From baseline (week 0) to week 52
measure: Change in triglycerides
timeFrame: From baseline (week 0) to week 52
measure: Change in free fatty acids
timeFrame: From baseline (week 0) to week 52
measure: Change in LDL (low density lipoprotein) cholesterol
timeFrame: From baseline (week 0) to week 52
measure: Change in HDL (high density lipoprotein) cholesterol
timeFrame: From baseline (week 0) to week 52
measure: Relative change in body weight
timeFrame: From baseline (week 0) to week 52
measure: Change in SF-36 (36-item Short Form Survey) bodily pain
timeFrame: From baseline (week 0) to week 52
measure: Change in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)pain
timeFrame: From baseline (week 0) to week 52
measure: Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score
timeFrame: From baseline (week 0) to week 52
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to week 59
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North AL Health Res, LLC
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Peoria
country: United States
facility: Inst-Liver Hlth dba AZ Liver H
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: La Jolla
country: United States
facility: UCSD NAFLD Research Center
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Redwood City
country: United States
facility: Stanford Medicine
state: California
city: Sacramento
country: United States
facility: UC Davis Hlth -Midtwn Ambu Cen
state: California
city: Colorado Springs
country: United States
facility: Peak Gastro Assoc-Col Springs
state: Colorado
city: Hartford
country: United States
facility: Hartford Hsptl_Hartford
state: Connecticut
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Miguel Rebollar PA
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research_Inverness
state: Florida
city: Jacksonville
country: United States
facility: UF Hlth Jacksonville
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U, Corp
state: Florida
city: Miami
country: United States
facility: Univ of Miami/Schiff Ctr
state: Florida
city: University Park
country: United States
facility: Covenant Metabolic Specialists LLC
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic Orlando Health
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Assoc_ CGA
state: Georgia
city: Marietta
country: United States
facility: Gastroint Spec of Georgia
state: Georgia
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana
state: Indiana
city: Kansas City
country: United States
facility: University Of Kansas Hospital
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic, PA
state: Kansas
city: Houma
country: United States
facility: Tandem Clinical Research - Houma
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center, GI Research
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed Nat Mil Md Ctr
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital_Detroit
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Florham Park
country: United States
facility: AIG Digestive Disease Research
state: New Jersey
city: New York
country: United States
facility: NYU Grossman School of Med
state: New York
city: New York
country: United States
facility: Weill Cornell Med Coll-NYPH
state: New York
city: Cleveland
country: United States
facility: Univ Hosp Cleveland Med Ctr
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Wexner Med Ctr
state: Ohio
city: Springboro
country: United States
facility: DSI Research,LLC
state: Ohio
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Liver Diseases
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC_Center for Liver Care
state: Pennsylvania
city: Hermitage
country: United States
facility: Digestive Health Res-TSMC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clin Res Inst, LLC
state: Texas
city: Dallas
country: United States
facility: Liver Ins@ Mthdist DTX Med Cen
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes &Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Amer. Rrsch Corp-TX Liver Inst
state: Texas
city: Sugar Land
country: United States
facility: Olympus Clinical Research
state: Texas
city: Waco
country: United States
facility: Impact Research
state: Texas
city: Wichita Falls
country: United States
facility: Digestive Hlth Res of N Texas
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Richmond Community Hospital LLC
state: Virginia
city: Roanoke
country: United States
facility: Gastroent Consult of SW VA
state: Virginia
city: Seattle
country: United States
facility: Swedish med ctr org trans-lvr ctr
state: Washington
city: Seattle
country: United States
facility: Liver Institute NW
state: Washington
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital - Hepatology- 5E291
state: South Australia
city: Clayton
country: Australia
facility: Monash Health Department of Gastroenterology
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Centre - Gastroenterology
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital - Hepatology
state: Western Australia
city: Bruxelles
country: Belgium
facility: CUB Hôpital Erasme_Brussels_0
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZ Gent - Department Gastro-enterology
city: Sofia
country: Bulgaria
facility: "Acibadem City Clinic UMHAT Tokuda"
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: "DCC XX - Sofia" EOOD
city: Calgary
country: Canada
facility: University of Calgary Liver Unit-(HMRC)
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Inst Foundation
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Liberec
country: Czechia
facility: Krajská nemocice Liberec, a.s
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital - Gastroenheden
city: København NV
country: Denmark
facility: Abdominal Center K, Research Unit
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers-1
city: Clichy
country: France
facility: Ap-Hp-Hopital Beaujon
city: Lyon Cedex 4
country: France
facility: Hospices Civils de Lyon-Hopital de La Croix Rousse
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice-Hopital de L'Archet 2
city: Paris
country: France
facility: Aphp-Hopital La Pitie Salpetriere-4
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Venissieux
country: France
facility: Centre de Recherche Clinique Portes Du Sud
city: Essen
country: Germany
facility: Klinik für Endokrinologie, Diabetologie und Stoffwechsel
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz - Hepatologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Zentrum für Innere Medizin (ZIM)
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, ZIM
city: Athens
country: Greece
facility: Gen Hospital of Athens Ippokrateio,B' Uni Clinic of Inte Med
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Goudi, Athens
country: Greece
facility: General Hospital of Athens "LAIKO"
city: Thessaloniki
country: Greece
facility: "AHEPA" University Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ippokrateio"
city: Secunderabad
country: India
facility: Yashoda Hospital
state: Andhra Pradesh
city: Surat
country: India
facility: Surat Institute of Digestive Science
state: Gujarat
city: Surat
country: India
facility: BAPS Pramukh Swami Hospital
state: Gujarat
city: Gurugram
country: India
facility: Medanta - The Medicity Multi-Speciality Hospital, Gurugram
state: Haryana
city: Mangalore
country: India
facility: Kasturba Medical College Hospitals (KMC Hospitals), Mangalore
state: Karnataka
city: Mumbai
country: India
facility: Gleneagles Hospital, Super-speciality and Transplant Centre, Parel
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS medical college and KEM Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Midas Multispeciality Hospital
state: Maharashtra
city: Ghitorni
country: India
facility: Institute of liver and Biliary Sciences
state: New Delhi
city: New Dehli
country: India
facility: All India Institute of medical Sciences
state: New Delhi
city: Chandigarh,
country: India
facility: Fortis Heart Institute and Multispeciality Hospital
state: Punjab
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research_Chandigarh
state: Punjab
city: Jaipur
country: India
facility: S.R.Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telagana
city: Hyderabad
country: India
facility: Dr P V Rao - Diabetes Research Centre
state: Telangana
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Azieda Ospedaliero-Universitaria, Policlinico S. Orsola-Malp
city: Firenze
country: Italy
facility: AOU Careggi Padiglione 16 San Luca, 3° piano
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova Clin.Med.3
city: Pisa
country: Italy
facility: AOU Pisana Stabilimento di Cisanello EDIFICIO 6, Piano 5
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rome
country: Italy
facility: Policlinico Università Campus Biomedico di Roma
city: Chiba-shi, Chiba
country: Japan
facility: Chiba University Hospital_Chiba-shi, Chiba
city: Fukui-shi, Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital, Internal Medicine
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Hatsukaichi-shi, Hiroshima
country: Japan
facility: JA Hiroshima General Hospital
city: Kamigyo-ku, Kyoto
country: Japan
facility: University Hospital Kyoto Prefectual University of Medicine
city: Kawasaki-shi, Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Minato-ku, Tokyo
country: Japan
facility: Toranomon Hospital, Hepatology
city: Okayama-shi, Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Saga-shi, Saga
country: Japan
facility: Saga University Hospital_Liver Center
city: Sendai-shi, Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Suita-shi, Osaka
country: Japan
facility: Saiseikai Suita Hospital, Gastroenterology
city: Toon-shi, Ehime
country: Japan
facility: Ehime University Hospital
city: Wakayama-shi, Wakayama
country: Japan
facility: Saiseikai Wakayama Hospital
city: Yokohama-shi, Kanagawa
country: Japan
facility: Yokohama City University Hospital, Gastrointestinal Medicine
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Mysłowice
country: Poland
facility: ID Clinic Arkadiusz Pisula
state: Malopolskie
city: Bydgoszcz
country: Poland
facility: Spolka Lekarzy Intercor Sp. z o.o.
city: Katowice
country: Poland
facility: Clinical Medical Research Korfantego - Ambulatoryjna Opieka
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibińskiego Śl
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Kraków
country: Poland
facility: "LANDA" Katarzyna Agata Landa
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A.
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych
city: Wroclaw
country: Poland
facility: FutureMeds Sp. z o.o.
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Santa Maria E.P.E.
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N. Burdenko
city: Singapore
country: Singapore
facility: National University Hospital Singapore_Tahir Building
city: Singapore
country: Singapore
facility: National University Hospital_TBD
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra - Hospital de Montecelo
state: Galicia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tıp Fakültesi- Gastroenteroloji
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi-Gastroe
city: Istanbul
country: Turkey
facility: Marmara Univ. Pendik Gastroenterology
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tıp Fakültesi Gastroenteroloji ve Hepat
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: