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

Description

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.

Conditions

Overweight, Obesity

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Overweight
Intervention / Treatment

-

Contacts and Locations

Lincoln

Celerion, Lincoln, Lincoln, Nebraska, United States, 68502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening.
  • * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
  • * Amylase greater than or equal to (\>=) 2 times upper limit of normal at screening
  • * Lipase greater than or equal to (\>=) times upper limit of normal at screening
  • * Calcitonin greater than or equal to (\>=) 50 nanogram per liter (ng/L) at screening

Ages Eligible for Study

19 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2025-07-17