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NCT Number: NCT07566390

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Glendale/LA EPCU, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • 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.
  • 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

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

Treatment and study plan

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

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of dosing (day 1) up to day 43

    Measured as number of events.

Secondary outcomes

  1. AUC: Area under the NNC0113-5840 plasma concentration time-curve

    Time frame: From pre-dose (day 1) up to day 43

    Measured as hours*nanomole per liter (h*nmol/L)

  2. Cmax: Maximum observed NNC0113-5840 plasma concentration

    Time frame: From pre-dose (day 1) up to day 43

    Measured as nanomoles per liter (nmol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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