JRCT ID: jRCT2031250828
Registered date:23/03/2026
A research study comparing how well different doses of the medicine NNC0662-0419 lower blood sugar in people with type 2 diabetes
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes |
| Date of first enrollment | 17/04/2026 |
| Target sample size | 25 |
| Countries of recruitment | United States,Japan,Croatia,Japan,Hungary,Japan,Poland,Japan,Portugal,Japan,Slovakia,Japan,South Korea,Japan,Spain,Japan,Thailand,Japan |
| Study type | Interventional |
| Intervention(s) | Drug: NNC0662-0419 NNC0662-0419 will be administered subcutaneously. Drug: Semaglutide Semaglutide will be administered subcutaneously. Drug: Placebo Placebo will be administered subcutaneously. |
Outcome(s)
| Primary Outcome | -Change in glycated haemoglobin (HbA1c) (week 16) [Time Frame: From baseline (week 0) to week 16]-Measured as percentage-point (%-point). -Change in HbA1c (week 28) [Time Frame: From baseline (week 0) to week 28]-Measured as %-point. -Change in HbA1c (week 40) [Time Frame: From baseline (week 0) to week 40]-Measured as %-point. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 75age old |
| Gender | Both |
| Include 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). |
| Exclude 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. |
Related Information
| Primary Sponsor | Miku Fukunaga |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT07415954 |
Contact
| Public contact | |
| Name | Administorator Clinical trail information |
| Address | 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005 |
| Telephone | +81-362661000 |
| JPHC_clinical_trials@novonordisk.com | |
| Affiliation | Novo Nordisk Pharma Ltd. |
| Scientific contact | |
| Name | Fukunaga Miku |
| Address | 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005 |
| Telephone | +81-362661000 |
| JPHC_clinical_trials@novonordisk.com | |
| Affiliation | Novo Nordisk Pharma Ltd. |