A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors
A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors
4 other identifiers
interventional
281
34 countries
163
Brief Summary
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2021
Typical duration for phase_3
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedStudy Start
First participant enrolled
December 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2024
CompletedDecember 8, 2025
December 1, 2025
2.3 years
September 13, 2021
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of treated bleeds
Count
No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (week 26)
Number of treated bleeds
Count
Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)
Secondary Outcomes (10)
Number of injection site reactions
All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of main (week 26)
Occurrence of anti-Mim8 antibodies
All participants receiving Mim8 (Arms 2a, 2b, 3 and 4): From randomisation (week 0) to end of extension (week 52)
Number of treated spontaneous bleeds
No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)
Number of treated joint bleeds
No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)
Number of treated traumatic bleeds
No prophylaxis treatment (Arms 1, 2a and 2b): From randomisation (week 0) to end of main (Week 26) Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)
- +5 more secondary outcomes
Study Arms (5)
no PPX- no PPX - Mim8 PPXQW/QM
EXPERIMENTALParticipants not receiving prophylaxis will not enter the run-in period. In arm 1, participants will be randomised to continue no prophylaxis (on-demand treatment with their Standard of Care products) or Mim8 once-weekly or once-monthly prophylaxis in agreement with investigators in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) in agreement with the investigator, either weekly or monthly Mim8 prophylaxis regimen.
no PPX - Mim8 PPXQW - Mim8 PPXQW
EXPERIMENTALParticipants not receiving prophylaxis will not enter the run-in period. In arm 2a, participants will be randomised to Mim8 once-weekly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.
no PPX - Mim8 PPXQM - Mim8 PPXQM
EXPERIMENTALParticipants not receiving prophylaxis will not enter the run-in period. In arm 2b, participants will be randomised to Mim8 once-monthly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthy Mim8 prophylaxis regimen.
PPX - Mim8 PPXQW
EXPERIMENTALParticipants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 3, participants will be randomised to once-weekly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.
PPX- Mim8 PPXQM
EXPERIMENTALParticipants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen.
Interventions
Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.
Eligibility Criteria
You may qualify if:
- 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.
- Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records.
- Participant has been prescribed treatment with factor VIII concentrates or bypassing agent in the last 26 weeks prior to screening.
- Age above or equal to 12 years at the time of signing informed consent.
- Body weight greater than or equal to 30 kg.
- Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
- Applicable to participants with FVIII activity ≥1% who are on prophylactic treatment: ≥1 bleed in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed.
- Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.
You may not qualify if:
- Previous participation in this study. Participation is defined as signed informed consent.
- Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned randomisation.
- Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned randomisation, for participants not included in the run-in.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Breast feeding is allowed only during the run-in period.
- Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products.
- Receipt of gene therapy at any given time point.
- Ongoing or planned immune tolerance induction (ITI) therapy.
- Major surgery planned to take place after screening.
- Known congenital or acquired coagulation disorders other than haemophilia A.
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above1.5 times the upper limit measured at screening.
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m\^2 for serum creatinine measured at screening.
- Previous or current thromboembolic disease or events (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
- Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (163)
Arizona H&T Phoenix Child Hosp
Phoenix, Arizona, 85016-7710, United States
Hemophilia Treatment Center
Los Angeles, California, 90007, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027, United States
Univ of Colorado Sch of Med
Aurora, Colorado, 80045, United States
Univ of Miami/SCCC
Miami, Florida, 33136, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
St Joseph's Hospital Foundation
Tampa, Florida, 33607, United States
Children HC Atlanta-Adv Pediat
Atlanta, Georgia, 30329, United States
Augusta University
Augusta, Georgia, 30912, United States
Memorial Health Univ Med Ctr
Savannah, Georgia, 31404, United States
Rush University Med. Cntr
Chicago, Illinois, 60612, United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, 46260, United States
University of Iowa_Iowa City
Iowa City, Iowa, 52242, United States
University Of Iowa
Iowa City, Iowa, 52242, United States
Children's Hosp-New Orleans
New Orleans, Louisiana, 70118-5720, United States
University Of Michigan
Ann Arbor, Michigan, 48109, United States
Michigan State University
East Lansing, Michigan, 48823, United States
Washington University School of Medicine_St. Louis
St Louis, Missouri, 63110, United States
Univ of NE Med Center_Omaha
Omaha, Nebraska, 68105, United States
Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Torrence Hemby Ped Hem/Onc Ctr
Charlotte, North Carolina, 28203, United States
St. Jude Clinic Novant Health
Charlotte, North Carolina, 28204, United States
Cincinnati Child's Hsp Med Ctr
Cincinnati, Ohio, 45229, United States
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children Hemostati Ctr
Dayton, Ohio, 45404, United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, 17033-2360, United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania, 19134, United States
Balad Hlth Sys-Welmont CardCVA
Kingsport, Tennessee, 37660, United States
Vanderbilt Hemostasis Thrombosis Clinic
Nashville, Tennessee, 37232-9830, United States
Children's Medical Center_Dallas
Dallas, Texas, 75235, United States
Univ TX Hlth Sci Ctr Houston
Houston, Texas, 77030, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Universitätsklinik für Innere Medizin V
Innsbruck, 6020, Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090, Austria
Cliniques universitaires Saint-Luc - Service Hématologie
Brussels, 1200, Belgium
UZ Antwerpen - UZA - Kinderhemato-Oncologie
Edegem, 2650, Belgium
UZ Leuven - Kindergeneeskunde
Leuven, 3000, Belgium
University of Manitoba
Winnipeg, Manitoba, R3T 2N2, Canada
St. John Regional Hospital
Saint John, New Brunswick, E2L 4L4, Canada
Eastern Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5, Canada
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
London Health Sciences Center Ontario
London, Ontario, N6A 5W9, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, HIT 2M4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
Haemotology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Nanfang Hospital, Southern Medical University-Haematology
Guangzhou, Guangdong, 510515, China
Tongji Hospital, Tongji Medical College of HUST-Hematology
Wuhan, Hubei, 430030, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Xiangya Hospital Central-South University
Changsha, Hunan, 410008, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jinan Central Hospital
Ji'Nan, Shandong, 250000, China
Jinan Central Hospital
Jinan, Shandong, 250000, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610074, China
Institute of Hematology and Blood Diseases Hospital, Tianjin-Hematology
Tianjin, Tianjin Municipality, 300020, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
The Children's Hospital, Zhejiang University school of medicine
Hangzhou, Zhejiang, 310052, China
Ustav Hematologie a krevni tranfuze
Prague, 128 20, Czechia
Rigshospitalet - Department of Haematology, 2081
København Ø, 2100, Denmark
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, 33076, France
Hospices Civils de Lyon- Hopital Louis Pradel-1
Bron, 69500, France
Hôpital Cardiologique Louis Pradel
Bron, 69500, France
Ap-Hp-Hopital de Bicetre-1
Le Kremlin-Bicêtre, 94275, France
Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon
Lille, 59037, France
Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu
Nantes, Nantes, France
Ap-Hp-Hopital Necker-1
Paris, 75015, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249, Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127, Germany
HZRM Haemophilie-Zentrum Rhein Main GmbH
Frankfurt am Main, 60596, Germany
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, 400012, India
Christian medical college
Ludhiana, Punjab, 141008, India
CMCV
Ranipet, Tamil Nadu, 632517, India
Post Graduate Institute of Child Health
Noida, Uttar Pradesh, 201303, India
St James's CRF
Dublin, Leinster, D08 A978, Ireland
CHI Crumlin Haematology
Dublin, D12 N512, Ireland
Sheba MC - The Israeli National Hemophilia Center
Tel Litwinsky, 52621, Israel
Dipartimento di Ematologia Univ. Firenze
Florence, 50134, Italy
IRCCS Humanitas Research Hospital - Centro Trombosi e Malattie Emorragiche
Milan, 20089, Italy
Nagoya University Hospital_Blood Transfusion
Aichi, 466-8560, Japan
Hospital of the University of Occupational And Environmental Health Japan, Pediatrics
Kitakyusyu-shi, Fukuoka, 807 8555, Japan
Nanbu Medical Center & Children's Medical Center
Okinawa, 901-1193, Japan
Saitama Children's Med Centre_Hematology-Oncology
Saitama, 330-8777, Japan
Shizuoka Children's Hospital, Hematology-Oncology
Shizuoka, 420-8660, Japan
Jichi Medical University Hospital_Hematology
Tochigi, 329-0498, Japan
Jichi Medical University Hospital_Pediatrics
Tochigi, 329-0498, Japan
National Center for Child Health and Development_Hematology
Tokyo, 157-8535, Japan
Tokyo Medical Univ. Hospital_Laboratory Medicine
Tokyo, 160-0023, Japan
Ogikubo Hospital_Pediatries & Blood
Tokyo, 167-0035, Japan
Stradini Clinic of Oncology
Riga, 1002, Latvia
Children University Clinical Hospital
Riga, 1004, Latvia
Hospital of LUHS "Kauno Klinikos"
Kaunas, LT-50161, Lithuania
Children Oncohaematology department Children's Hospital,
Vilnius, 08406, Lithuania
Vilnius University hospital Santaros klinikos
Vilnius, LT-08661, Lithuania
Hospital Queen Elizabeth 1
Kota Kinabalu, Sabah, 88586, Malaysia
Hospital Ampang
Ampang, Selangor, 68000, Malaysia
Hospital Ampang
Selangor Darul Ehsan, 68000, Malaysia
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigación Clínica En Yucatán S.C.P. (CEMDEICY S.C.P.)
Mérida, 97130, Mexico
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
UMC Utrecht, Van Creveldkliniek
Utrecht, 3584 CX, Netherlands
Szpital Uniwersytecki, Oddzial Kliniczny Hematologii
Krakow, Lesser Poland Voivodeship, 30-688, Poland
Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa
Lublin, 20-093, Poland
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3000-561, Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4099-001, Portugal
Centro Hospitalar de São João_Porto
Porto, 4200-319, Portugal
ULS São João, E.P.E.
Porto, 4200-319, Portugal
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Dolj, 200143, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Institut Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, 400015, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300254, Romania
Reg. State Budget Healthc. Inst. Regional Clinical Hospital
Barnaul, 656024, Russia
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, 650066, Russia
Children Regional Clinical Hospital
Krasnodar, 350007, Russia
Morozovskaya municipal children hospital
Moscow, 119049, Russia
National Medical Research institution of haemotology
Moscow, 125167, Russia
Republican Hospital n.a. V. A. Baranov
Petrozavodsk, 185019, Russia
City out-patient clinic 37, City Hemophilia Centre
Saint Petersburg, 191186, Russia
King Faisal Specialist Hospital & Research Centre, Riyadh
Riyadh, 12713, Saudi Arabia
Clinical Centre of Serbia, Institute for Haematology
Belgrade, 11000, Serbia
Clinical Centre of Vojvodina
Novi Sad, 21000, Serbia
Nemocnica sv. Cyrila a Metoda, UNB,Klinika hemat. a transfuz
Bratislava, 851 07, Slovakia
Unilabs Slovensko, s. r. o.
Košice, 04001, Slovakia
Univerzitna Nemocnica Martin
Martin, 036 59, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12, Slovakia
Vranovska nemocnica, a.s.
Vranov nad Topľou, 09327, Slovakia
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, 2013, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, 2193, South Africa
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Málaga
Málaga, 29009, Spain
Universitätsklinik für Hämatologie
Bern, 3010, Switzerland
Zentrum für Labormedizin
Sankt Gallen, 9008, Switzerland
Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
Zurich, 8091, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Pediatrics
Kaohsiung City, 807, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Taiwan University Hospital_Dept of Hematology
Taipei, 100, Taiwan
Gazi University
Ankara, Beşevler/Ankara, 06500, Turkey (Türkiye)
Gazi Üniversitesi Hastanesi- Hematoloji
Ankara, Beşevler/Ankara, 06500, Turkey (Türkiye)
Istanbul University Oncology Institute
Capa-ISTANBUL, Capa-ISTANBUL, 34093, Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Onkoloji Enstitüsü
Capa-ISTANBUL, Capa-ISTANBUL, 34093, Turkey (Türkiye)
Akdeniz Üniversitesi Hastanesi- Hematoloji
Antalya, Konyaaltı/ Antalya, 01010, Turkey (Türkiye)
Acıbadem Adana Hastanesi-Hematoloji
Adana, 01130, Turkey (Türkiye)
Akdeniz Universitesi
Antalya, 01010, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova-IZMIR, 35100, Turkey (Türkiye)
Ege Üniversitesi Hastanesi- Hematoloji
Bornova-IZMIR, 35100, Turkey (Türkiye)
City Clinical Hospital #4 (Dnipro) - Haematology centre
Dnipro, 49102, Ukraine
Institute of blood pathology and transfusion medicine of NAMSU - General and haematol. surgery
Lviv, 79044, Ukraine
Arthur Bloom Haemophilia Centre
Cardiff, CF14 4XW, United Kingdom
Royal Free Haemophilia Comprehensive Care Centre
London, NW3 2QG, United Kingdom
St Thomas' Hospital - Haemostasis and Thrombosis Centre
London, SE1 7EH, United Kingdom
Oxford Haemophilia Comprehensive Care Center
Oxford, OX3 7LJ, United Kingdom
Related Publications (1)
Ong Clausen WH, Latendorf T, Stehr R, Ezban M, Lund J. Comparative ex vivo analysis of Mim8 in thrombin generation assays triggered by activated factor XI or tissue factor. Res Pract Thromb Haemost. 2025 Oct 10;9(7):103209. doi: 10.1016/j.rpth.2025.103209. eCollection 2025 Oct.
PMID: 41257207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
September 22, 2021
Study Start
December 2, 2021
Primary Completion
March 11, 2024
Study Completion
December 17, 2024
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com