Authorised Therapeutic exploratory (Phase II) type 2 diabetes

A research study comparing how well different doses of the medicine NNC0662-0419 lower blood sugar in people with type 2 diabetes

EU CTIS ID: 2025-523260-20-00

What this study is testing

To demonstrate and characterise the dose-response relationship of once weekly (QW) s.c. NNC0662‑0419 for change in HbA1c from CCI in patients with T2D CCI

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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.
6. Glycated haemoglobin (HbA1c) of 7.0-10.0% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
7. CCI
CCI
8. Able and willing to adhere to the protocol CCI or the study, as judged by the investigator.
9. Willingness to obtain a high weight loss (> 25% of weight at baseline).

You likely can't join if

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
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
19. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomaa.
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).
20. Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before screening.
21. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.

See the full eligibility criteria

Who can join

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

What rules you out

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
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
19. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomaa.
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).
20. Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before screening.
21. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
22. Planned coronary, carotid or peripheral artery revascularisation.
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.
24. Use of any medication with unknown or unspecified content within 90 days before screening.
25. CCI
26. Inadequately treated blood pressure defined as systolic ≥180 mmHg or diastolic ≥110 mmHg at screening.
10. Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.
27. CCI
28. CCI
29. Calcitonin ≥ 50.0 ng/L (pg/mL) at screening.
3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 838 (see Section 8.1 for instruction).
30. Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
31. CCI
32. CCI
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.
34. Any condition, unwillingness or inability, which in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
35. A prior solid organ transplant or awaiting solid organ transplant.
11. Known or suspected hypersensitivity to study intervention(s) or related products.
4. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator (see Appendix 8, Section 10.8).
5. Any episode of diabetic ketoacidosis within 180 days before screeninga.
6. History of gastroparesisa.
7. 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).
8. 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.
9. A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
36. Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
CCI
37. CCI
12. Previous randomisation in this study.
13. Previous rescreening for this study. For details on which criteria an individual is allowed to be rescreened on, see Section 5.4.
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).
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.
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.
17. Any history or presence of pancreatitisa.

The study team makes the final eligibility decision.

Where it's taking place

Korea, Republic of
Japan
Thailand
United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Korea, Republic of; Japan; Thailand; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease Atrial fibrillation

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.