NCT06287437

HRS9531 Controls Weight Regain in Obese Subjects

A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	HRS9531	HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks.
DRUG	HRS9531 placebo	HRS9531 placebo low frequency injection for 12 weeks.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

1 site across 1 country: China