HRS-2129 for 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 trial will test whether HRS-2129 tablets reduce pain in adults with diabetic peripheral neuropathy compared with placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07377721 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional study in China testing HRS-2129 tablets versus placebo with pregabalin and matching placebos included in the design. Adults with diabetic peripheral neuropathic pain for at least 3 months, HbA1c ≤ 9%, and baseline VAS pain of 40–90 mm are eligible. Participants will receive study medications and be monitored for safety, tolerability, and changes in pain scores. Study procedures include regular pain assessments, laboratory tests, and ECGs at two hospital sites in Beijing and Chongqing.

Who should consider this trial

Good fit: Adults (≥18) with documented diabetic peripheral neuropathic pain for ≥3 months, baseline VAS 40–90 mm, HbA1c ≤9%, and stable antidiabetic therapy are the ideal candidates.

Not a fit: People with non‑diabetic neuropathy, significant liver or kidney dysfunction, prolonged QTc, severe allergies, or prior failure of high‑dose pregabalin/gabapentin are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HRS-2129 could provide a new oral treatment option to reduce neuropathic pain for people with diabetic peripheral neuropathy.

How similar studies have performed: Approved drugs such as pregabalin and gabapentin have demonstrated effectiveness for diabetic neuropathic pain, while HRS-2129 is an investigational compound without published large-scale efficacy data.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lei Tang

Conditions Diabetic Peripheral Neuropathic Pain