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A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT07377721•Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

September 1, 2026

Completion Date

November 1, 2026

Last Updated

March 3, 2026

Enrollment

168

ESTIMATED participants

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

HRS-2129 Tablets

DRUG

HRS-2129 Placebo

DRUG

Pregabalin Capsules

DRUG

Pregabalin Capsules Placebo

DRUG

Contacts

Lei Tang

CONTACT

+86-0518-82342973 lei.tang.lt31@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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