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NCT Number: NCT07415954

A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Opca bolnica Karlovac, Karlovac, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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).

Exclusion 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.

Treatment and study plan

NNC0662-0419

Drug

NNC0662-0419 will be administered subcutaneously.

semaglutide

Drug

Semaglutide will be administered subcutaneously.

Placebo

Drug

Placebo will be administered subcutaneously.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c) (week 16)

    Time frame: From baseline (week 0) to week 16

    Measured as percentage-point (%-point).

  2. Change in HbA1c (week 28)

    Time frame: From baseline (week 0) to week 28

    Measured as %-point.

  3. Change in HbA1c (week 40)

    Time frame: From baseline (week 0) to week 40

    Measured as %-point.

Secondary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to (week 40)

    Measured as percentage (%).

  2. Change in body weight

    Time frame: From baseline (week 0) to (week 40)

    Measured as kilogram (kg).

  3. Change in HbA1c

    Time frame: From baseline (week 0) to (week 16, 28 and 40)

    Measured as %-point.

  4. Change in Fasting Plasma Glucose (FPG)

    Time frame: From baseline (week 0) to (week 16, 28 and 40)

    Measured as millimoles per litre (mmol/L).

  5. Change in Body Mass Index (BMI)

    Time frame: From baseline (week 0) to (week 40)

    Measured in kilograms per square metre (kg/m^2).

  6. Change in waist circumference

    Time frame: From baseline (week 0) to (week 40)

    Measured in centimetre (cm).

  7. Change in high sensitivity C-Reactive Protein (hsCRP)

    Time frame: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  8. Change in total cholesterol

    Time frame: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  9. Change in High-Density Lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  10. Change in Low-Density Lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  11. Change in triglycerides

    Time frame: From baseline (week 0) to (week 40)

    Measured as ratio to baseline.

  12. Change in Urine Albumin Creatinine Ratio (UACR)

    Time frame: From baseline (week 0) to (week 16, 28 and 40)

    Measured as ratio to baseline.

  13. Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021)

    Time frame: From baseline (week 0) to (week 40)

    Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m^2).

  14. Number of adverse events

    Time frame: From baseline (week 0) to (week 48)

    Measured as number of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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