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

Launched by NOVO NORDISK A/S · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called NNC0662-0419, which is being tested for its potential to help people living with overweight or obesity. The main goals of the study are to find out if this medicine is safe and how it works in the body. Participants will either receive the NNC0662-0419 medicine or a placebo (a “dummy” injection that does not contain any active ingredients) through an injection under the skin. Which treatment a participant will get is determined by chance. This is the first time this medicine is being tested in humans, and the entire study will last about 9 months.

To be eligible for the study, participants need to be between 19 and 55 years old and have a body mass index (BMI) between 27 and 39.9, which indicates they are overweight. Additionally, they must pass certain health checks and tests to ensure their safety. Those who have specific health issues, such as high blood sugar or certain abnormal lab results, may not be able to participate. Participants can expect regular check-ins with the study staff to monitor their health throughout the trial. This study is currently recruiting participants of any gender who meet the criteria.

Gender

ALL

Eligibility criteria

• 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