Actively Recruiting
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
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-15
168
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of HRS-2129 in Chinese adults with diabetic peripheral neuropathic pain (DPNP). This phase 1, multicenter, randomized, double-blind trial compares HRS-2129 to placebo and pregabalin capsules to better understand its effects on pain relief in patients with DPNP lasting at least three months. Participants may receive one of several study treatments: high dose or low dose HRS-2129 tablets, pregabalin capsules, or placebos matching these drugs. The study includes a 4-week treatment period with assessments at baseline and Week 4. Blood samples will be collected to study the pharmacokinetics of HRS-2129. The trial uses a quadruple masking design to keep participants and researchers unaware of the assigned treatments. During the study, participants will report their average daily pain using scales such as the Average Daily Pain Score and Visual Analog Scale. Other measures include sleep interference, patient global impressions, and pain questionnaires. Safety is closely monitored by tracking adverse events over 6 weeks. The study began in March 2026 and is expected to complete by November 2026.
CONDITIONS
Brief Title
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent.
- Male or female aged 18 years or older.
- Diagnosed with diabetic peripheral neuropathic pain and diabetic peripheral neuropathy pain lasting 3 months or more.
- HbA1c of 9.0% or less at screening and on stable antidiabetic medication for at least 30 days before screening.
- Pain score on Visual Analog Scale between 40 mm and less than 90 mm at screening.
You will not qualify if you...
- History of severe allergies.
- Peripheral neuropathy or pain not related to diabetic peripheral neuropathy that may affect pain assessment.
- Abnormal liver or kidney function.
- Corrected QT interval greater than 450 ms for males or greater than 470 ms for females.
- No response to previous pregabalin treatment at doses of 300 mg/day or higher, or gabapentin at doses of 1200 mg/day or higher for diabetic peripheral neuropathic pain.
- History of suicidal behavior or attempted suicide.
- Participation in another clinical trial within 3 months prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive HRS-2129 tablets, pregabalin capsules, or matching placebos as part of the study treatment.
Weekly visits for up to 4 weeks
Duration - 2 weeks
Participants are monitored for safety and adverse events after the treatment period.
Visits at Weeks 5 and 6
Trial Site Locations
Total: 2 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
L
Lei Tang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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