A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Enicepatide in Adult Chinese Participants With Body Mass Index ≥23.0 kg/m2

Registration

Registration

NCT07626515

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

RECRUITING

Enrollment

36

Start

2026-07-02

Primary completion

2027-05-14

Lead sponsor

Hoffmann-La Roche

Conditions

Healthy Participants

Interventions

COMBINATION_PRODUCT:Enicepatide; COMBINATION_PRODUCT:Placebo

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• 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)]