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Completed

NCT Number: NCT06326047

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Macquarie University, Macquarie Park, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female of non-childbearing potential, or male.
  • For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
  • Age 18-75 years (both inclusive) at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
  • Stable daily dose(s) more than or equal 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose co-transporter 2 (SGLT2) inhibitor.
  • Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
  • Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).

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. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. 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 question.

Treatment and study plan

NNC0519-0130

Drug

NNC0519-0130 will be administered subcutaneously.

Placebo

Drug

Placebo will be administered subcutaneously.

Trizepatide

Drug

Trizepatide will be administered subcutaneously.

Primary outcomes

  1. Change in Glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose

    Measured as percentage point (%-point)

Secondary outcomes

  1. Change in Glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as percentage point (%-point)

  2. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as percentage (%)

  3. Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as kilograms (kg)

  4. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose

    Measured as millimoles per liter (mmol/L)

  5. Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))

    Time frame: From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively

    Measured as percentage point (%-point)

  6. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as centimeter (cm)

  7. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as millimeters of mercury (mmHg)

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

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as ratio to baseline

  9. Change in total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as ratio to baseline

  10. Change in high-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as ratio to baseline

  11. Change in low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as ratio to baseline

  12. Change in triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Measured as ratio to baseline

  13. Number of adverse events

    Time frame: From baseline (week 0) to end of study (week 40)

    Measured as number of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Dec 31, 2025

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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