HRS-2129 for diabetic peripheral neuropathic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lei.tang.lt31@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.