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NCT Number: NCT06737536

A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or Obesity

This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.

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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

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

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)
  • Aged 19-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • 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.

Exclusion criteria

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (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.
  • Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
  • Calcitonin >= 50 nanogram per liter (ng/L) at screening

Treatment and study plan

NNC0662-0419

Drug

Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.

Placebo (NNC0662-0419)

Other

Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.

Primary outcomes

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

    Time frame: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)

    Number of events

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

    Time frame: From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)

    Number of events

Secondary outcomes

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

    Time frame: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)

    measured in hour*nanomoles per liter (h*nmol/L)

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

    Time frame: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)

    measured in nanomoles per liter(nmol/L)

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

    Time frame: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

    measured in h*nmol/L

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

    Time frame: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

    measured in nmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Sep 19, 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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