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A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity

A First in Human Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC0113-5840 in Participants With Overweight or Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a new medicine, NNC0113-5840, is safe for adults ages 18–55 with overweight or obesity. Participants will get either the study medicine or a placebo, a treatment with no active medicine. The treatment they get is chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male or female.
  • Age 18–55 when signing the form to agree to join.
  • BMI of 25.0–34.9 at screening. BMI is a measure of weight compared with height. The study doctor must judge that the extra weight is from extra body fat.
  • The study doctor must find you eligible based on your health history, physical exam, vital signs, heart rhythm test, and lab tests at screening and the visit on day -1.

Who can't join

  • Known or suspected allergy to the study treatments or related products.
  • Any condition that the study doctor thinks could make the study unsafe for you or make it hard to follow study rules.
  • HbA1c of 6.5% or higher at screening. This blood test measures your average blood sugar over time.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

CA

MD