A Dose-Finding Study to Evaluate the Efficacy and Safety of Once-Weekly Subcutaneous NNC0662-0419 in Participants with Type 2 Diabetes
- Trial ID
- 2025-523260-20-00
- Protocol
- NN9662-8160
- Sponsor
- Novo Nordisk A/S
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to characterize the dose-response relationship of once-weekly subcutaneous NNC0662-0419 regarding the change in HbA1c from the clinical baseline in participants with type 2 diabetes. This evaluation is clinically significant for determining optimal dosing regimens for glycemic control. Secondary objectives include:
- Characterization of the dose-response relationship for changes in body weight from the clinical baseline.
- Comparison of the effects of once-weekly subcutaneous NNC0662-0419 versus placebo in this patient population.
Participants
This study involves a total of 125 participants, including both patients and healthy volunteers. The study population comprises males and females aged 18 to 75 years. Eligible participants must have a diagnosis of type 2 diabetes at least 180 days prior to screening. A key requirement for inclusion is a glycated haemoglobin level between 7.0% and 10.0%. Additionally, participants must demonstrate a willingness to achieve significant weight loss exceeding 25% of their baseline weight.
Plans and Procedures
This Phase II clinical trial is a dose-finding study designed to characterize the dose-response relationship of NNC0662-0419 in participants with type 2 diabetes. The study utilizes a subcutaneous administration route for the investigational product, which is compared against a comparator and placebo. The primary endpoint is the change in HbA1c from concomitant medication initiation. Secondary endpoints include evaluations of body weight. The clinical process begins with a screening visit to assess eligibility, including requirements for glycated haemoglobin levels and a diagnosis of diabetes mellitus for at least 180 days. Following screening, participants undergo study procedures to evaluate the efficacy and safety of the once-weekly dosing regimen. The estimated duration of the trial spans from April 2026 to September 2027.
Treatment
The investigational medicinal product is NNC0662-0419, which is administered as a solution for injection via the subcutaneous route on a once-weekly schedule.
The comparator treatment is Ozempic, containing semaglutide, provided as a solution for injection in a pre-filled pen for subcutaneous administration. The study also utilizes Placebo A and Semaglutide B Placebo as non-active controls.
Efficacy
The efficacy of once-weekly subcutaneous NNC0662-0419 will be evaluated in participants with type 2 diabetes. The primary endpoint is the change in HbA1c from clinical baseline.
Secondary endpoints include the change in body weight and the relative change in body weight.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
- CCI
- CCI
- Able and willing to adhere to the protocol CCI or the study, as judged by the investigator.
- Willingness to obtain a high weight loss (> 25% of weight at baseline).
- Male or female (sex at birth).
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- CCI
- Glycated haemoglobin (HbA1c) of 7.0-10.0% (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
Exclusion Criteria
- 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
- Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous randomisation in this study.
- Previous rescreening for this study. For details on which criteria an individual is allowed to be rescreened on, see Section 5.4.
- 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).
- 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.
- 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.
- Any history or presence of pancreatitisa.
- 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
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomaa.
- 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).
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before screening.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- 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.
- Use of any medication with unknown or unspecified content within 90 days before screening.
- CCI
- Inadequately treated blood pressure defined as systolic ≥180 mmHg or diastolic ≥110 mmHg at screening.
- CCI
- CCI
- Calcitonin ≥ 50.0 ng/L (pg/mL) at screening.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire, question 838 (see Section 8.1 for instruction).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- CCI
- CCI
- 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.
- Any condition, unwillingness or inability, which in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
- A prior solid organ transplant or awaiting solid organ transplant.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator (see Appendix 8, Section 10.8).
- Any episode of diabetic ketoacidosis within 180 days before screeninga.
- History of gastroparesisa.
- 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).
- 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.
- A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
- Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
- CCI
- CCI
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Croatia | Recruiting | 28 Apr 2026 | 20 |
 Hungary | Not Yet Recruiting | 28 Apr 2026 | 20 |
 Poland | Recruiting | 28 Apr 2026 | 37 |
 Portugal | Recruiting | 28 Apr 2026 | 25 |
 Slovakia | Recruiting | 28 Apr 2026 | 20 |
 Spain | Recruiting | 28 Apr 2026 | 35 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Ozempic 0.5 mg solution for injection in pre-filled pen | Comparator | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS | 00 | 1 | PRD6392563 |
Placebo A | Placebo | N/A | — | — | 1 | N/A |
Semaglutide B Placebo | Placebo | N/A | — | — | — | N/A |