Status:
COMPLETED
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin
Eligibility Criteria
Inclusion
- Male or female
- Aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) between 27.0 and 39.9 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
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c equal to or greater than 6.5 % (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) below 12 ng/mL (30 nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Amylase equal to or greater than 2 times upper limit of normal at screening
- Lipase equal to or greater than 2 times upper limit of normal at screening
- Calcitonin equal to or greater than 50 ng/L at screening
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06064006
Start Date
September 15 2023
End Date
November 27 2024
Last Update
November 19 2025
Active Locations (2)
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1
ICON Early Phase Services, LLC
San Antonio, Texas, United States, 78209
2
Novo Nordisk INvestigational Site
San Antonio, Texas, United States, 78209