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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
Incidence and Severity of Adverse Events
Time frame: 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
Time frame: Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Pulse Rate
Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Respiratory Rate
Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Systolic Blood Pressure
Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Diastolic Blood Pressure
Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Body Temperature
Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Plasma Concentration of Enicepatide
Time frame: At prespecified time points from Day 1 to Day 190
Maximum Plasma Concentration Observed (Cmax) of Enicepatide
Time frame: At prespecified time points from Day 1 to Day 190
Time to Cmax (Tmax) of Enicepatide
Reference Study ID Number: YP46402 https://forpatients.roche.com/
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Time frame: At prespecified time points from Day 1 to Day 190
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide
Time frame: At prespecified time points from Day 1 to Day 190
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide
Time frame: At prespecified time points from Day 1 to Day 190
Absolute Change From Baseline in Body Weight
Time frame: Baseline through Week 24
Percent Change From Baseline in Body Weight
Time frame: Baseline through Week 24