First-in-human look at how NNC0721-8060 works in people who are overweight or obese

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 Phase 1 interventional study examines the safety, tolerability, pharmacokinetics, and pharmacodynamics of NNC0721-8060 in adults with BMI 27.0-34.9 kg/m2. Participants are randomized to receive NNC0721-8060, semaglutide, or placebo to compare effects. Eligible individuals are 18-55 years old with overweight due to adipose tissue, and must meet other screening criteria. The trial is conducted at two sites in the United States under the lead sponsorship of Novo Nordisk A/S.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female (sex at birth).
* Age 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) 27.0-34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator.
* Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous randomisation in this study.
* History of allergies (with the exception of seasonal allergies) or history of anaphylactic reactions.
* Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using adequate contraception.
* Current participation (signed informed consent) in any other interventional clinical study.
* Exposure to an investigational medicinal product within 30 days or five half-lives of that product (whichever is longer) before screening.
* Any disorder, unwillingness or inability which, in the investigator's opinion, might jeopardise participant safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole \[mmol/mol\]) at screening.

Where it's running

• ICON Early Phase Services, LLC
  Lenexa, Kansas, United States Recruiting
• Icon
  San Antonio, Texas, United States Not yet 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.