NNC0662-0419 for Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- 1.    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.\n- 6.    Glycated haemoglobin (HbA1c) of 7.0-10.0% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.\n- 7. CCI\n- CCI\n- 8.    Able and willing to adhere to the protocol CCI or the study, as judged by the investigator.\n- 9.    Willingness to obtain a high weight loss (> 25% of weight at baseline).\n- 2.    Male or female (sex at birth).\n- 3.    Age 18-75 years (both inclusive) at the time of signing the informed consent.\n- 4. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.\n- 5. CCI"}

Exclusion criteria

• {"criterion_text":"- 1.    Treatment with any medication for the indication of diabetes or obesity CCI within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days CCI\n- 18.  Renal impairment with estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 by central laboratory at screening (eGFR creatinine-cystatin C CKD-EPI 2021).39\n- 19.  Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomaa.\n- 2.  Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. CCI Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination (for eye examination see Section 8.3.5).\n- 20.  Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before screening.\n- 21.  Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.\n- 22.  Planned coronary, carotid or peripheral artery revascularisation.\n- 23.  Presence or historya of malignant neoplasms, neoplasms potential affecting the endocrine system or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.\n- 24.  Use of any medication with unknown or unspecified content within 90 days before screening.\n- 25. CCI\n- 26.  Inadequately treated blood pressure defined as systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg at screening.\n- 10.  Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.\n- 27.  CCI\n- 28.  CCI\n- 29.  Calcitonin ≥ 50.0 ng/L (pg/mL) at screening.\n- 3.  Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 838 (see Section 8.1 for instruction).\n- 30.  Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.\n- 31.  CCI\n- 32.  CCI\n- 33.  Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the study as judged by the investigator.\n- 34.  Any condition, unwillingness or inability, which in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.\n- 35.  A prior solid organ transplant or awaiting solid organ transplant.\n- 11.  Known or suspected hypersensitivity to study intervention(s) or related products.\n- 30.  Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator (see Appendix 8, Section 10.8).\n- 31.  Any episode of diabetic ketoacidosis within 180 days before screeninga.\n- 32.  History of gastroparesisa.\n- 33.  Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).\n- 34.  Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a)    Liposuction and/or abdominoplasty, if performed > 1 year before screening, b)    Adjustable gastric banding, if the band has been removed > 1 year before screening, c)    Intragastric balloon, if the balloon has been removed > 1 year before screening or d)    Duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.\n- 35.  A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.\n- 36.  Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.\n- 37.  CCI\n- 38.  CCI\n- 12.  Previous randomisation in this study.\n- 13.  Previous rescreening for this study. For details on which criteria an individual is allowed to be rescreened on, see Section 5.4.\n- 14.  Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).\n- 15.  Current participation (i.e., signed informed consent) in any other interventional clinical study. Note: Participants are allowed to be simultaneously screened for any other interventional clinical study at the same clinical site where the participant is screened for this study if the screening activities include a minimal risk to the participant. Participants can initiate study intervention in this study only when participation in any other interventional clinical study is discontinued.\n- 16.  Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.\n- 17.  Any history or presence of pancreatitisa.\n- 18.  CCI"}

Primary endpoints

• {"endpoint_text":"- Change in HbA1c","definition_or_measurement_approach":"Change in HbA1c from CCI (change from baseline); HbA1c assessed by central laboratory as indicated in screening procedures."}

Secondary endpoints

• {"endpoint_text":"- Relative change in body weight\n- Change in body weight","definition_or_measurement_approach":"Change in body weight from CCI (baseline); relative change denotes percent change from baseline. Body weight measured per protocol assessments."}

Croatia

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

35

Number Of Sites

4

Number Of Participants

20

Portugal

Earliest CTIS Part Ii Submission Date

24-02-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

57

Number Of Sites

4

Number Of Participants

25

Spain

Earliest CTIS Part Ii Submission Date

11-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

47

Number Of Sites

6

Number Of Participants

35

Poland

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

31

Number Of Sites

5

Number Of Participants

25

Slovakia

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

29

Number Of Sites

4

Number Of Participants

20

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

CCI

Name

IQVIA Limited

Responsibilities

Central Laboratory & CCI

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CCI","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Metabolon Inc.","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"CCI","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Special laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory & CCI","organisation_type":"Pharmaceutical company"}