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A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

NCT07415954 · Novo Nordisk A/S
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Official title
Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study
About this study
This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
Eligibility criteria
Inclusion criteria * Male or female (sex at birth). * Age 18-75 years (both inclusive) at the time of signing the informed consent. * Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as assessed by central laboratory at screening. * Willingness to obtain a high weight loss (greater than \[\>\] 25% of weight at baseline). Exclusion criteria * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.
Study design
Enrollment target: 270 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-17
Estimated completion: 2027-10-01
Last updated: 2026-05-19
Interventions
Drug: NNC0662-0419Drug: SemaglutideDrug: Placebo
Primary outcomes
  • Change in glycated haemoglobin (HbA1c) (week 16) (From baseline (week 0) to week 16)
  • Change in HbA1c (week 28) (From baseline (week 0) to week 28)
  • Change in HbA1c (week 40) (From baseline (week 0) to week 40)
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency (dept. 2834) · study_director, Novo Nordisk A/S
All locations (63)
First Valley Medical GroupRecruiting
Lancaster, California, United States
Torrance Clinical Research Institute, Inc.Recruiting
Lomita, California, United States
Ark Clinical ResearchRecruiting
Long Beach, California, United States
Pacific Clinical StudiesRecruiting
Los Alamitos, California, United States
Wetlin Research Associates, Inc.Recruiting
San Diego, California, United States
Diablo Clinical Research, Inc.Recruiting
Walnut Creek, California, United States
Encore Medical Research LLCRecruiting
Hollywood, Florida, United States
Bioclinical Research AllianceRecruiting
Miami, Florida, United States
South Broward Research LLCRecruiting
Miramar, Florida, United States
West Orange EndocrinologyNot Yet Recruiting
Ocoee, Florida, United States
Encore Medical Research of WestonRecruiting
Weston, Florida, United States
Elite Clinical TrialsRecruiting
Blackfoot, Idaho, United States
Cedar-Crosse Research CenterRecruiting
Chicago, Illinois, United States
Brigham & Women's HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Headlands ResearchRecruiting
Springfield, Missouri, United States
PharmQuestRecruiting
Greensboro, North Carolina, United States
Piedmont Healthcare StatesvilleRecruiting
Statesville, North Carolina, United States
Providence Center for Clinical ResearchRecruiting
Dayton, Ohio, United States
CNS HealthcareRecruiting
Memphis, Tennessee, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
JCCT- Juno NW HoustonRecruiting
Houston, Texas, United States
Consano Clinical Research, LLCRecruiting
Shavano Park, Texas, United States
Frontier Clinical Research - KingwoodNot Yet Recruiting
Kingwood, West Virginia, United States
Opca bolnica KarlovacRecruiting
Karlovac, Croatia
Poliklinika SLAVONIJA OSIJEKRecruiting
Osijek, Croatia
Opca bolnica Varazdin_EndocrinologyRecruiting
Varaždin, Croatia
Poliklinika SolmedRecruiting
Zagreb, Croatia
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai KözpontNot Yet Recruiting
Szeged, Csongrád-Csanád, Hungary
Debreceni EgyetemNot Yet Recruiting
Debrecen, Hajdú-Bihar, Hungary
Debreceni EgyetemNot Yet Recruiting
Debrecen, Hungary
Akaicho Clinic_Diabetes Internal MedicineRecruiting
Chiba-shi, Chiba, Japan
Naka Kinen Clinic_Internal medicineRecruiting
Ibaraki, Japan
Soka Sugiura Internal Medicine ClinicRecruiting
Soka-shi, Saitama, Japan
Tokyo-Eki Center-building Clinic_Internal MedicineRecruiting
Tokyo, Japan
ToCROM Clinic_Internal MedicineRecruiting
Tokyo, Japan
"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy SupronikNot Yet Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Terpa Sp. z o.o. Sp. k.Not Yet Recruiting
Lublin, Poland
Formed 2 Sp. z o.o.Recruiting
Oświęcim, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiARecruiting
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. SzyszkoRecruiting
Zabrze, Poland
Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios ClínicosRecruiting
Coimbra, Portugal
Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima LdaRecruiting
Ponte de Lima, Portugal
Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios ClínicosRecruiting
Vila do Conde, Portugal
Hospital da Luz Arrábida, S.A_Serviço de EndocrinologiaRecruiting
Vila Nova de Gaia, Portugal
DIADA, s.r.o.Recruiting
Bardejov, Slovakia
Metabol KLINIK s.r.o.Recruiting
Bratislava, Slovakia
Diacrin s. r. o.Recruiting
Bratislava, Slovakia
SIN AZUCAR s.r.o.Recruiting
Malacky, Slovakia
Korea University Ansan Hospital_EndocrinologyNot Yet Recruiting
Ansan-si, Gyeonggi-do, South Korea
Pusan National University Yangsan HospitalNot Yet Recruiting
Yangsan, Gyeongsangnam-do, South Korea
Nowon Eulji Medical Center, Eulji University_EndocrinologyNot Yet Recruiting
Seoul, South Korea
Kangbuk Samsung Hospital_EndocrinologyNot Yet Recruiting
Seoul, South Korea
Centro de Salud A EstradaNot Yet Recruiting
A Estrada, Spain
Equip D´Atencio Primaria Barcelona SardenyaRecruiting
Barcelona, Spain
Hospital Vithas SevillaRecruiting
Castilleja de la Cuesta, Spain
Clínica BofillRecruiting
Girona, Spain
ABS La Roca del Vallés_EndocrinologíaRecruiting
La Roca Del Vallés, Spain
Centro de Saúde Concepción ArenalNot Yet Recruiting
Santiago de Compostela, Spain
Ramathibodi HospitalNot Yet Recruiting
Bangkok, Thailand
Siriraj HospitalNot Yet Recruiting
Bangkok, Thailand
Maharaj Nakorn Chiang MaiNot Yet Recruiting
Chiang Mai, Thailand
Srinagarind HospitalNot Yet Recruiting
Khon Kaen, Thailand
Maharat Nakhon Ratchasima HospitalNot Yet Recruiting
Nakhon Ratchasima, Thailand
A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes · TrialPath