A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants

Registration

Registration

NCT07793019

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

RECRUITING

Enrollment

104

Start

2026-09-07

Primary completion

2027-09-06

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Conditions

Overweight; Healthy Participants; Obesity

Interventions

DRUG:Orforglipron; DRUG:Matching Placebo; DRUG:IBI3042

Results posted

FALSE

Registered primary outcomes

• Number of Participants With Adverse Events (Part A) [through study completion, an average of 29 days]
• Number of Participants With Abnormal Physical Examination Findings (Part A) [through study completion, an average of 29 days]
• Number of Participants With Clinically Significant Abnormal Vital Signs (Part A) [through study completion, an average of 29 day]
• Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A) [through study completion, an average of 29 days]
• Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A) [through study completion,an average of 29 days]
• Number of Participants With Adverse Events (Part B) [through study completion, an average of 113 days]
• Number of Participants With Abnormal Physical Examination Findings (Part B) [through study completion, an average of 113 days]
• Number of Participants With Clinically Significant Abnormal Vital Signs (Part B) [through study completion, an average of 113 days]
• Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B) [through study completion, an average of 113 days]
• Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B) [through study completion, an average of 113 days]