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
Zenagamtide injection: Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm
Zenagamtide tablet: Zenagamtide tablet will be taken in the morning in fasted state.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state — From 0 (pre-dose) up to Day 196 and Day 224 Measured as nanomoles per liter hourly (h\*nmol/L)
Trial sites (1)
Facility
City
Region
Status
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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