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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules; Drug: Pregabalin Capsules Placebo

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lei Tang; Phone Number: +86-0518-82342973; Email: lei.tang.lt31@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Bifa Fan; Phone Number: +86-15010101616; Email: fbf1616@yeah.net
      • Principal Investigator: Bifa Fan
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Principal Investigator: Qifu Li
      • Contact: Qifu Li; Phone Number: +86-18696676815; Email: liqifu@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-2129 High Dose Group	Drug: HRS-2129 Tablets; HRS-2129 tablets.; Drug: HRS-2129 Placebo; HRS-2129 placebo.; Drug: Pregabalin Capsules Placebo; Pregabalin capsules placebo.
Experimental: HRS-2129 Low Dose Group	Drug: HRS-2129 Tablets; HRS-2129 tablets.; Drug: HRS-2129 Placebo; HRS-2129 placebo.; Drug: Pregabalin Capsules Placebo; Pregabalin capsules placebo.
Active Comparator: Pregabalin Group	Drug: HRS-2129 Placebo; HRS-2129 placebo.; Drug: Pregabalin Capsules; Pregabalin capsules.
Placebo Comparator: Blank Preparation Placebo Group	Drug: HRS-2129 Placebo; HRS-2129 placebo.; Drug: Pregabalin Capsules Placebo; Pregabalin capsules placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline).	Ratio of participants responding to treatment, as measured by Average Daily Pain Score (ADPS) reduction from baseline. The ADPS is used to determine categorical response rates.	Baseline and Week 4.
Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 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.	From Week 1 to Week 4.
Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4.	VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.	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.	Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score: Part 1 - 11 descriptors of pain intensity, and 4 descriptors of emotions, on a scale of 0 (none) to 3 (severe); Part 2 - a Visual Analog Scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain; Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain).	Baseline and Week 4.
Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4.	Patient Global Impression of Change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse.	At Week 4.
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4.	The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.	Baseline and Week 4.
Number and severity of serious adverse events (SAEs).	To evaluate the safety of HRS-2129 during the trial.	From Week 1 to Week 6.
Number and severity of adverse events (AEs).	To evaluate the safety of HRS-2129 during the trial.	From Week 1 to Week 6.
Population Pharmacokinetics (PopPK) characteristics of HRS-2129 in Chinese patients with diabetic peripheral neuropathic pain - Serum concentration of HRS-2129.	Population Pharmacokinetics (PopPK) will be determined by measuring serum concentration of HRS-2129.	From Day 0 to Day 30.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Organic Chemicals; Acids, Acyclic; Carboxylic Acids; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Pregabalin
• Other Study ID Numbers: HRS-2129-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No