Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT07184632
Eligibility Criteria:
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:
1. 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
2. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07184632
Study Brief:
Protocol Section:
NCT07184632