Safety testing of NNC6989-0001 in adults 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, randomized, placebo-controlled first-in-human study of NNC6989-0001 conducted in adults living with overweight or obesity. The study includes a single ascending dose (Part A) and a multiple ascending dose (Part B) where participants receive either the investigational drug or placebo assigned by chance. Eligible participants are generally healthy adults aged 18–55 with specified BMI ranges and must meet screening safety criteria. The trial is sponsored by Novo Nordisk and conducted at a single early-phase clinical site in Lenexa, Kansas.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female of non-childbearing potential.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
* 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, as judged by the investigator.

Exclusion Criteria:

* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
* Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
* Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.

Where it's running

• ICON Early Phase Services, LLC
  Lenexa, Kansas, 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.