A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Diabetic Peripheral Neuropathic Pain
In brief
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
Key facts
- Study ID
- NCT07377721
- Run by
- Shandong Suncadia Medicine Co., Ltd.
- People needed
- 168
- Starts
- 2026-03-24
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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