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

NCT07377721 | Recruiting Phase 1

• 1 other identifier: HRS-2129-105
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4.

  The mean change in Average Daily Pain Score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]). The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.

  Baseline and Week 4.

Secondary Outcomes (9)

• Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline).

  Baseline and Week 4.

• Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4.

  From Week 1 to Week 4.

• Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4.

  Baseline and Week 4.

• Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HRS-2129 and placebo at Week 4.

  Baseline and Week 4.

• Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4.

  At Week 4.

Study Arms (4)

HRS-2129 High Dose Group

EXPERIMENTAL

Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo

HRS-2129 Low Dose Group

EXPERIMENTAL

Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo

Pregabalin Group

ACTIVE COMPARATOR

Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules

Blank Preparation Placebo Group

PLACEBO COMPARATOR

Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo

Interventions

HRS-2129 Placebo DRUG

HRS-2129 placebo.

Blank Preparation Placebo Group; HRS-2129 High Dose Group; HRS-2129 Low Dose Group; Pregabalin Group

Pregabalin Capsules DRUG

Pregabalin capsules.

Pregabalin Group

Pregabalin Capsules Placebo DRUG

Pregabalin capsules placebo.

Blank Preparation Placebo Group; HRS-2129 High Dose Group; HRS-2129 Low Dose Group

HRS-2129 Tablets DRUG

HRS-2129 tablets.

HRS-2129 High Dose Group; HRS-2129 Low Dose Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent.
• Males or females aged ≥18years of age inclusive.
• Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
• HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
• At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and \< 90 mm.

You may not qualify if:

• Subjects with a history of severe allergies.
• Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
• Subjects with abnormal liver and renal function.
• Corrected QT Interval (QTc): \> 450 ms (male), \> 470 ms (female).
• 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).
• History of suicidal behavior or attempted suicide.
• Participated in another clinical study within 3 months prior to screening.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Lei Tang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-2129 compared with placebo.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (2)