Status:
ACTIVE_NOT_RECRUITING
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does...
Eligibility Criteria
Inclusion
- 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:
- Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
Exclusion
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06577766
Start Date
September 3 2024
End Date
September 24 2026
Last Update
December 23 2025
Active Locations (1)
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1
ICON
San Antonio, Texas, United States, 78209