How meal timing and water amount affect how Zenagamtide is absorbed

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 will compare the pharmacokinetics of Zenagamtide when administered as tablets or injections under varying meal and water conditions in adults with overweight or obesity. All participants receive Zenagamtide, and absorption will be measured through blood samples to see how timing with meals and water volume influence exposure. The trial will screen participants for safety and baseline health, then administer the intervention with careful monitoring. The goal is to identify dosing conditions that optimize absorption while ensuring safety. The study is sponsored by Novo Nordisk A/S and conducted at Charité in Berlin, Germany.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female (sex assigned at birth, inclusive of all gender identities).
* 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:

* 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.
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
* Unusual meal habits (including, but not limited to, eating disorders) and special diet
* HbA1c more than or equal to (≥) 6.5 percent (%) \[48 (nanomoles per mole) mmol/mol\] at screening.

Where it's running

• Charité - Campus Charité Mitte - Charité Research Organisation GmbH
  Berlin, Germany 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.