NCT05813795

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

Detailed description

In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.

Conditions

• Weight Management

Interventions

Type	Name	Description
DRUG	Ecnoglutide Low Dosage	Subcutaneous Injection
DRUG	Ecnoglutide Medium Dosage	Subcutaneous Injection
DRUG	Ecnoglutide High Dosage	Subcutaneous Injection
DRUG	Placebo	Subcutaneous Injection with matched volume

Timeline

• Start date: 2023-04-05
• Primary completion: 2024-06-20
• Completion: 2024-10-10
• First posted: 2023-04-14
• Last updated: 2025-04-30

Locations

1 site across 1 country: China