Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus

Phase 2

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Biological: CPX101 or placebo 120mg Q2W; Biological: CPX101 or placebo 160mg Q2W; Biological: CPX101 or placebo 240mg Q2W; Biological: CPX101 or placebo 160mg Q4W; Biological: CPX101 or placebo 240mg Q4W; Biological: CPX101 or placebo 360mg Q4W; Biological: CPX101 or placebo 360mg Q2W

• Registration Number: NCT06532578
• Lead Sponsor: Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.

Brief Summary

The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.

Detailed Description

240 subjects who meet the eligibility criteria will be randomized to 5 cohorts in a 2:3:3:2:2 ratio (CPX101 120mg Q2W, CPX101 160mg Q4W, CPX101 160mg Q2W, CPX101 240mg Q4W, CPX101 240mg Q2W).Participants in each cohort will be randomized in a 3:1 ratio to receive either CPX101 or placebo. The study consists of a 3-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.Dose-titration will be adopted within each cohort to improve GI tolerability.

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-01
• Study Start: 2024-08-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	CPX101 or placebo 120mg Q2W	-
Cohort 3	CPX101 or placebo 160mg Q2W	-
Cohort 5	CPX101 or placebo 240mg Q2W	-
Cohort 2	CPX101 or placebo 160mg Q4W	-
Cohort 4	CPX101 or placebo 240mg Q4W	-
Cohort 2	CPX101 or placebo 160mg Q4W	-
Cohort 3	CPX101 or placebo 160mg Q2W	-
Cohort 4	CPX101 or placebo 240mg Q4W	-
Cohort 4	CPX101 or placebo 360mg Q4W	-
Cohort 1	CPX101 or placebo 120mg Q2W	-
Cohort 5	CPX101 or placebo 240mg Q2W	-
Cohort 5	CPX101 or placebo 360mg Q2W	-

Primary Outcome Measures

Name	Time	Method
Efficacy of CPX101 in body weight loss in Kg	Up to 24 weeks after administration	To evaluate the efficacy of CPX101 in body weight loss by dose levels after 24 weeks of multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus.

Secondary Outcome Measures

Name	Time	Method
Other efficacy parameters of CPX101(Waist circumference in centimeters)	Up to 24 weeks after administration	To evaluate the efficacy of waist circumference of CPX101 by dose levels after 24 weeks of multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus
Immunogenicity of CPX101	Up to 24 weeks after administration	Measurement of the anti-CPX101 antibody in serum after multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus.
Other efficacy parameters of CPX101(BMI)	Up to 24 weeks after administration	BMI = wight (kg)/(height\[m\])\^2 ;To evaluate BMI of CPX101 by dose levels after 24 weeks of multiple subcutaneous injections in overweight and abese subjects without diabetes mellitus.
Incidence of AE/SAE	Up to 36 weeks	The safety of CPX101
The plasma concentration of CPX101	Up to 24 weeks after administration	Measurement of the plasma concentration of CPX101 in serum after multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus.

Trial Locations

Locations (1)

Paratus Clinical Research; 🇦🇺 Chatswood, New South Wales, Australia