How a new medicine (NNC0113-5840) may help with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study to evaluate the safety of NNC0113-5840 in adults with a BMI of 25.0 to 34.9 kg/m2. Participants are randomly assigned to receive either NNC0113-5840 or a placebo. The trial includes screening visits to assess health and eligibility, followed by treatment and monitoring for adverse effects and basic safety parameters. The study is sponsored by Novo Nordisk A/S and conducted at two U.S. clinical research sites, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• PAREXEL Glendale/LA EPCU
  Glendale, California, United States Recruiting
• PAREXEL Intl - EPCU-Baltimore
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.