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Purpose

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. 4. 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 and visit 2, day -1, as judged by the investigator.

Exclusion Criteria

  1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 3. Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) [48 millimole per mole (mmol/mol)] at screening.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental
Cohort 2 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental
Cohort 3 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental
Cohort 4 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental
Cohort 5 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental
Cohort 6 NNC0113-5840 		Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.
  • Drug: NNC0113-5840
    NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Placebo Comparator
Placebo matching NNC0113-5840 		Participants will receive placebo matched to NNC0113-5840 subcutaneously.
  • Drug: Placebo
    Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.

Recruiting Locations

PAREXEL Glendale/LA EPCU
Glendale, California 91206

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.