A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity
Overview
- Phase
- Phase 1
- Intervention
- NNC0638-0355
- Conditions
- Obesity
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Part A: Number of treatment emergent adverse events (TEAE)
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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 to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
Investigators
Eligibility Criteria
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.
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
Arms & Interventions
NNC0638-0355
Participants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD).
Intervention: NNC0638-0355
Placebo
Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD).
Intervention: Placebo (NNC0638-0355)
Outcomes
Primary Outcomes
Part A: Number of treatment emergent adverse events (TEAE)
Time Frame: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
Measured as Number of events
Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
Time Frame: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)
Measured as Number of events
Secondary Outcomes
- Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve(From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks))
- Part A: Cmax; maximum observed NNC0638-0355 plasma concentration(From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks))
- Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve(From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks))
- Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration(From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks))