A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity
Purpose
The purpose of the study is to find out if NNC0721-8060 is safe and how it works in people living with overweight or obesity.
Conditions
- Overweight
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female (sex at birth). - Age 18-55 years (both inclusive) at the time of signing informed consent. - Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator. - Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.
Exclusion Criteria
- Known or suspected hypersensitivity to study intervention(s) or related products. - Previous randomisation in this study. - History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions. - Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception. - Current participation (signed informed consent) in any other interventional clinical study. - Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening. - Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol. - Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NNC0721-8060 |
Participants will receive subcutaneous injection of NNC0721-8060. |
|
|
Active Comparator Semaglutide |
Participants will receive subcutaneous injection of semaglutide. |
|
|
Placebo Comparator Placebo |
Participants will receive subcutaneous injection of placebo. |
|
Recruiting Locations
ICON Early Phase Services, LLC
Lenexa, Kansas 66219
Lenexa, Kansas 66219
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S