NCT07377721

A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	HRS-2129 Tablets	HRS-2129 tablets.
DRUG	HRS-2129 Placebo	HRS-2129 placebo.
DRUG	Pregabalin Capsules	Pregabalin capsules.
DRUG	Pregabalin Capsules Placebo	Pregabalin capsules placebo.

Timeline

• Start date: 2026-03-24
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2026-01-30
• Last updated: 2026-04-15

Locations

2 sites across 1 country: China