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NCT07815067
A Research Study Looking at the Effect of Timing of Meal After Dosing and Water Volume at Dosing on How the Medicine Zenagamtide is Taken up by the Body of Participants With Overweight or Obesity
Conditions: Overweight, Obesity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 320
Sponsor: Novo Nordisk A/S
Location: Charité - Campus Charité Mitte - Charité Research Organisation GmbH Berlin
Summary
The purpose of this clinical study is to test how taking zenagamtide tablets with different meal/water variations affects how much zenagamtide enters the bloodstream in people who have overweight or obesity. All participants will get zenagamtide.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07815067). StuddyBuddy aggregates publicly available trial information.