Enicepatide: Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Placebo: Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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/m\^2 at screening
* Agreement to adhere to the contraception requirements
Exclusion Criteria:
* 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
* Clinically significant abnormalities (as judged by the investigator) in laboratory test results
* History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction
Primary outcome measure(s)
Incidence and Severity of Adverse Events — Baseline to Safety Follow-Up (27 weeks)
Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade — Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Pulse Rate — At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Respiratory Rate — At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Systolic Blood Pressure — At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Diastolic Blood Pressure — At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Body Temperature — At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.