A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

Study Overview
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Brief Summary
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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

Official Title
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A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: NNC0487-0111
* Drug: Placebo (NNC0487-0111)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0487-0111<br>Participants will be randomized to receive NNC0487-0111. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD) Part B and C: Multiple ascending dose (MAD) | Drug: NNC0487-0111<br>* NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.<br>Drug: Placebo (NNC0487-0111)<br>* Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.<br>|
| Placebo Comparator: Placebo<br>Participants will be randomized to receive Placebo. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD). Part B and C: Multiple ascending dose (MAD). | Drug: NNC0487-0111<br>* NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.<br>Drug: Placebo (NNC0487-0111)<br>* Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PART A: Number of treatment emergent adverse events (TEAE) | Number of events | From pre-dose on Day 1 until completion of the end of study visit, up to 24 days | 
| Parts B and C: Number of treatment emergent adverse events (TEAE) | Number of events | From pre-dose on Day 1 until completion of the end of study visit, up to 35 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | h*nmol/L | From pre-dose on Day 1 until completion of the end of study visit, up to 24 days | 
| PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax | nmol/L | From pre-dose on Day 1 until completion of the end of study visit, up to 24 days | 
| Parts B and C: The area under the NNC0487-0111 plasma concentration-time curve. | h*nmol/L | From pre-dose on V33 Day1 until V34, up to 9 days | 
| Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax | nmol/L | From pre-dose on V33 Day 1 until end of study visit, up to 23 days |