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NCT Number: NCT07184632

A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Celerion, Phoenix, Tempe, Arizona, United States

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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 at the time of signing the informed consent:
  • For Part A:18-55 years (both inclusive)
  • For Part B and Part C: 18-65 years (both inclusive)
  • Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
  • For Part A: 27.0-39.9 kilogram per square meter(kg/m^2) (both inclusive)
  • For Part B and Part C:
  • Greater than or equal to (≥) 27.0 kg/m^2 with the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease), or
  • Greater than or equal to (≥) 30.0 kg/m^2
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as-judged by the investigator.
  • Willingness to obtain a high weight loss (greater than [>] 25 percent [%]).

Exclusion criteria

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Treatment with any compound containing Glucagon-Like Peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or amylin receptor agonism within 90 days before screening.
  • Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
  • 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
  • Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimoles per mole [mmol/mol]) at screening.
  • History of type 1 or type 2 diabetes mellitus.
  • Calcitonin greater than or equal to (≥) 50 nanogram per litre (ng/L) at screening.

Treatment and study plan

NNC0662-0419

Drug

NNC0662-0419 will be administered subcutaneously.

Placebo

Drug

Placebo matched to NNC0662-0419 will be administered subcutaneously.

Primary outcomes

  1. Part A: Number of treatment-emergent adverse events (TEAE)

    Time frame: From baseline (week 0) to end of study (up to week 44)

    Measured as number of events.

  2. Part B: Relative change in body weight

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

    Measured as percentage (%).

  3. Part C: Occurrence of premature treatment discontinuation (Yes/No)

    Time frame: At end of treatment (week 24)

    Measured as count of participants.

Secondary outcomes

  1. Part A: Relative change in body weight

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

    Measured as percentage (%).

  2. Part A: Change in body weight

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

    Measured in kilograms (kg).

  3. Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve

    Time frame: From pre-dose on day 1 to completion of the end of study visit (up to week 44)

    Measured in hours*nanomole per litre (h*nmol/L).

  4. Part A: Cmax; the maximum plasma concentration of NNC0662-0419

    Time frame: From pre-dose on day 1 to completion of the end of study visit (up to week 44)

    Measured in nanomole per litre (nmol/L).

  5. Part B: Change in body weight

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

    Measured in kg.

  6. Part B: Body weight reduction greater than or equal to (≥) 5% (Yes/No)

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

    Measured as count of participants.

  7. Part B: Body weight reduction ≥ 10% (Yes/No)

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

    Measured as count of participants.

  8. Part B: Body weight reduction ≥ 15% (Yes/No)

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

    Measured as count of participants.

  9. Part B: Body weight reduction ≥ 20% (Yes/No)

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

    Measured as count of participants.

  10. Part B: Body weight reduction ≥ 25% (Yes/No)

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

    Measured as count of participants.

  11. Part B: Number of treatment emergent adverse events (TEAE)

    Time frame: From baseline (week 0) to end of study (week 39)

    Measured as number of events.

  12. Part C: Number of treatment emergent adverse events (TEAE)

    Time frame: From baseline (week 0) to end of study (week 27)

    Measured as number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study Investigating Safety, Tolerability and Efficacy of Once-weekly NNC0662-0419 in Participants Living With Overweight or Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
May 7, 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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