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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT06577766
Eligibility Criteria:
Key inclusion criteria
* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered to be generally healthy 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.
Key exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
2. Parathyroid hormone (PTH) outside normal range at screening
3. Total calcium outside normal range at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06577766
Study Brief:
Protocol Section:
NCT06577766