A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity
Overview
- Phase
- Phase 2
- Intervention
- NNC0487-0111
- Conditions
- Obesity
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- PART A: Number of treatment emergent adverse events (TEAE)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
NNC0487-0111
Participants will be randomized to receive NNC0487-0111. 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: NNC0487-0111
NNC0487-0111
Participants will be randomized to receive NNC0487-0111. 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 (NNC0487-0111)
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: NNC0487-0111
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 (NNC0487-0111)
Outcomes
Primary Outcomes
PART A: Number of treatment emergent adverse events (TEAE)
Time Frame: From pre-dose on Day 1 until completion of the end of study visit, up to Day 25
Number of events
PARTS B to E: Number of treatment emergent adverse events (TEAE)
Time Frame: From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270
Number of events
Secondary Outcomes
- PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose on Day 1 until completion of the end of study visit, up to Day 25)
- PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax(From pre-dose on Day 1 until completion of the end of study visit, up to Day 25)
- PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose(From pre-dose on V33D1 until end of treatment (V34) up to 9 days)
- PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax(From pre-dose on V33D1 until end of study visit (V37) up to 24 days)
- PART B to E: Relative change in body weight(From pre-dose on Day 1 until end of treatment (V34) up to Day 255)