About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Zenagamtide injection
DrugZenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm
Zenagamtide tablet
DrugZenagamtide tablet will be taken in the morning in fasted state.
Treatment groups
Trial outcomes
Primary outcomes
AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state
Measured as nanomoles per liter hourly (h\*nmol/L)
Secondary outcomes
Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state
Measured as nanomoles per liter (nmol/L)
tmax, zenagamtide, ss: the time to maximum observed plasma concentration of zenagamtide at steady state
Measured as hours
t1/2, ss; the terminal half-life of zenagamtide after the last dose
Measured as hours
Sponsors and contacts
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