Clinical trial
A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07566390
Recruiting nowPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight
Full registry criteria
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.
Treatments and study arms
NNC0113-5840
Drug
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Placebo
Drug
Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Primary outcomes
Number of treatment emergent adverse events (TEAEs)From time of dosing (day 1) up to day 43
Measured as number of events.