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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Healthy volunteers, Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2026-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2025-523260-20-00

WHO UTN

U1111-1324-0310

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Dose response

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

Secondary objectives 2

1. Secondary objective 1: To characterise the dose‑response relationship of once weekly (QW) s.c. NNC0662‑0419 for change in body weight from CCI in patients with T2D CCI
2. Secondary objective 2: To compare the effect of once weekly (QW) s.c. NNC0662‑0419 versus placebo in patients with T2D CCI

Conditions and MedDRA coding

type 2 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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

Exclusion criteria 38

1. 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
2. 10.  Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.
3. 11.  Known or suspected hypersensitivity to study intervention(s) or related products.
4. 12.  Previous randomisation in this study.
5. 13.  Previous rescreening for this study. For details on which criteria an individual is allowed to be rescreened on, see Section 5.4.
6. 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).
7. 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.
8. 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.
9. 17.  Any history or presence of pancreatitisa.
10. 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
11. 19.  Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomaa.
12. 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).
13. 20.  Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before screening.
14. 21.  Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
15. 22.  Planned coronary, carotid or peripheral artery revascularisation.
16. 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.
17. 24.  Use of any medication with unknown or unspecified content within 90 days before screening.
18. 25. CCI
19. 26.  Inadequately treated blood pressure defined as systolic ≥180 mmHg or diastolic ≥110 mmHg at screening.
20. 27.  CCI
21. 28.  CCI
22. 29.  Calcitonin ≥ 50.0 ng/L (pg/mL) at screening.
23. 3.     Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 838 (see Section 8.1 for instruction).
24. 30.  Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
25. 31.  CCI
26. 32.  CCI
27. 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.
28. 34.  Any condition, unwillingness or inability, which in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
29. 35.  A prior solid organ transplant or awaiting solid organ transplant.
30. 4.     Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator (see Appendix 8, Section 10.8).
31. 5.     Any episode of diabetic ketoacidosis within 180 days before screeninga.
32. 6.     History of gastroparesisa.
33. 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).
34. 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.
35. 9.     A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
36. 36.  Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
37. CCI
38. 37.  CCI

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c

Secondary endpoints 2

1. Relative change in body weight
2. Change in body weight

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 11

Locations

6 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 118 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications