Status:
COMPLETED
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel ...
Eligibility Criteria
Inclusion
- Part A and B:
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening
- 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.
- Part C and D:
- Male or female aged 18-55 years (both inclusive) at time of signing informed consent
- Body mass index (BMI) of 27.0 to 39.9 kg/m\^2 (both inclusive) at screening
- 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
- Part A and B:
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 6.5 % (48 millimoles per mole (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 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Amylase greater than or equal to 2 times upper limit of normal at screening
- Lipase greater than or equal to 2 times upper limit of normal at screening
- Part C and D:
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- HbA1c greater than or equal to 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) less than 20 ng/mL (50 nM) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Amylase greater than or equal to 2 times upper limit of normal at screening
- Lipase greater than or equal to 2 times upper limit of normal at screening
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05369390
Start Date
May 11 2022
End Date
January 9 2024
Last Update
June 15 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