NCT05881837

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	HRS9531 injection	HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
DRUG	HRS9531 injection	HRS9531 injection: dose level 2
DRUG	HRS9531 injection	HRS9531 injection: dose level 3
DRUG	HRS9531 injection	HRS9531 injection: dose level 4
DRUG	HRS9531 injection Placebo	Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
DRUG	HRS9531 injection Placebo	Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
DRUG	HRS9531 injection Placebo	Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
DRUG	HRS9531 injection Placebo	Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks

Timeline

• Start date: 2023-06-13
• Primary completion: 2024-10-13
• Completion: 2024-10-13
• First posted: 2023-05-31
• Last updated: 2025-04-30

Locations

26 sites across 1 country: China