Status:
RECRUITING
A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07184632
Start Date
October 1 2025
End Date
December 1 2026
Last Update
December 15 2025
Active Locations (2)
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1
Celerion, Phoenix
Tempe, Arizona, United States, 85283
2
Celerion, Lincoln
Lincoln, Nebraska, United States, 68502