Study S003405

A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity

ClinicalTrials.gov record

Registration

Registration: NCT07809945
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: TRIPLE
Status: NOT_YET_RECRUITING
Enrollment: 128
Start: 2026-09-15
Primary completion: 2028-07-16
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Conditions: Obesity and Overweight
Interventions: DRUG:IBI3046; DRUG:placebo
Results posted: FALSE

Registered primary outcomes

Number of participants with Adverse Event [up to Day 169 for SAD;up to Day 225 for MAD]
Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg) [up to Day 169 for SAD;up to Day 225 for MAD]
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg) [up to Day 169 for SAD;up to Day 225 for MAD]
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants) [up to Day 169 for SAD;up to Day 225 for MAD]
Number of participants with clinically significant changes in physical examination results； [up to Day 169 for SAD;up to Day 225 for MAD]
Number of participants with abnormal ECG changes before and after administration in each dose group [up to Day 169 for SAD;up to Day 225 for MAD]

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