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Completed

NCT Number: NCT06326060

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 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 42 weeks.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Paratus Clinical, Bruce, Australian Capital Territory, Australia

Loading trial locations.

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.

a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening 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.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.
  • a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
  • b) BMI ≥ 30.0 kg/m2.

Exclusion criteria

  • HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes mellitus.
  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

Treatment and study plan

NNC0519-0130

Drug

NNC0519-0130 will be administered subcutaneously.

Placebo

Drug

Placebo will be administered subcutaneously.

Tirzepatide

Drug

Tirzepatide will be administered subcutaneously.

Primary outcomes

  1. Relative change in body weight

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

    Measured in percentage of body weight.

Secondary outcomes

  1. Change in body weight

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

    Measured in kilograms (kg)

  2. Achievement of greater than equal to (≥) 5% weight reduction

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

    Count of participants

  3. Achievement of ≥ 10% weight reduction

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

    Count of participants

  4. Achievement of ≥ 15% weight reduction

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

    Count of participants

  5. Achievement of ≥ 20% weight reduction

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

    Count of participants

  6. Change in body mass index (BMI)

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

    Measured in Kilogram per meter square (Kg/m^2)

  7. Change in waist circumference

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

    Measured in centimeter (cm)

  8. Change in glycated hemoglobin (HbA1c)

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

    Measured in percentage point (%-point)

  9. Change in fasting plasma glucose (FPG)

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

    Measured in millimoles per liter (mmol/L)

  10. Change in systolic blood pressure (SBP)

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

    Measured in milliters of mercury (mmHg)

  11. Change in high sensitivity C-Reactive protein (hsCRP)

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

    Ratio to baseline

  12. Change in total cholesterol

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

    Ratio to baseline

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

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

    Ratio to baseline

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

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

    Ratio to baseline

  15. Change in triglycerides

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

    Ratio to baseline

  16. Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score

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

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).

  17. Change in IWQOL-Lite-CT Psychosocial composite score

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

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).

  18. Change in IWQOL-Lite-CT Physical Function score

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

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).

  19. Change in IWQOL-Lite-CT Total score

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

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100).

  20. Number of adverse events

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

    Count 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 Overweight or Obesity - a Dose Finding Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Apr 15, 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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