NCT06532578

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Trial to Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BIOLOGICAL	CPX101 or placebo 120mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 160mg Q4W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 160mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 240mg Q4W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 240mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 320mg Q2W	CPX101 or placebo 320mg Q2W
BIOLOGICAL	CPX101 or placebo 360mg Q4W	CPX101 or placebo 360mg Q4W

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-12-15
• Completion: 2026-04-01
• First posted: 2024-08-01
• Last updated: 2026-04-15

Locations

1 site across 1 country: Australia