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Clinical Trials in China / NCT07377721
Recruiting Phase 1

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

NCT07377721 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 1
Started
2026-03-24
Last updated
2026-04-15

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

HRS-2129 TabletsHRS-2129 PlaceboPregabalin Capsules →Pregabalin Capsules Placebo

HRS-2129 Tablets: HRS-2129 tablets.

HRS-2129 Placebo: HRS-2129 placebo.

Pregabalin Capsules: Pregabalin capsules.

Pregabalin Capsules Placebo: Pregabalin capsules placebo.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Males or females aged ≥18years of age inclusive. 3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months. 4. HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible. 5. At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and \< 90 mm. Exclusion Criteria: 1. Subjects with a history of severe allergies. 2. Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP). 3. Subjects with abnormal liver and renal function. 4. Corrected QT Interval (QTc): \> 450 ms (male), \> 470 ms (female). 5. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral neuropathic pain (DPNP). 6. History of suicidal behavior or attempted suicide. 7. Participated in another clinical study within 3 months prior to screening.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting

More Shandong Suncadia Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07377721 on ClinicalTrials.gov ↗ ← All trials in China