About this trial
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m\^2).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests
BMI ≥23 kg/m² at screening
Agreement to adhere to the contraception requirements
Disqualifiers
History of acute or chronic pancreatitis
History of clinically significant gallbladder disease in the opinion of the investigator
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
History or presence of an abnormal ECG that is deemed clinically significant in the opinion of the investigator
Trial design
Parallel
Treatments tested in this trial
Enicepatide
Combination productParticipants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Placebo
Combination productParticipants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and Severity of Adverse Events
Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
Change from Baseline in Pulse Rate
Change from Baseline in Respiratory Rate
Secondary outcomes
Plasma Concentration of Enicepatide
Maximum Plasma Concentration Observed (Cmax) of Enicepatide
Time to Cmax (Tmax) of Enicepatide
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide
Sponsors and contacts
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