Diabetic Peripheral Neuropathic PainPhase 1NCT07377721
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
A Phase 1 study testing HRS-2129 Tablets and Pregabalin Capsules in people with Diabetic Peripheral Neuropathic Pain, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- HRS-2129 Tablets and Pregabalin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 2 sitesChina
- Study dates
- 24 Mar 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Bifa Fan, +86-15010101616, fbf1616@yeah.net
Bifa Fan
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qifu Li, +86-18696676815, liqifu@yeah.net
Qifu Li
About this study
Official title: 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.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- HRS-2129 Tablets, HRS-2129 Placebo, Pregabalin Capsules, Pregabalin Capsules Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2129 TabletsDrug
HRS-2129 tablets.
HRS-2129 PlaceboDrug
HRS-2129 placebo.
Pregabalin CapsulesDrug
Pregabalin capsules.
Pregabalin Capsules PlaceboDrug
Pregabalin capsules placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-2129 High Dose Group | Experimental | Not described Receives: Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo |
| HRS-2129 Low Dose Group | Experimental | Not described Receives: Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo |
| Pregabalin Group | Active comparator | Not described Receives: Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules |
| Blank Preparation Placebo Group | Placebo comparator | Not described Receives: Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4.
Number and severity of serious adverse events (SAEs).
To evaluate the safety of HRS-2129 during the trial.
Measured: From Week 1 to Week 6.
Number and severity of adverse events (AEs).
To evaluate the safety of HRS-2129 during the trial.
Measured: 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.
Measured: From Day 0 to Day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start24 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-2129 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377721
- Sponsor's protocol ID
- HRS-2129-105
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07377721
- Acronym / sponsor ID
- HRS-2129-105
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- HRS-2129 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS-2129 High Dose Group | Experimental | Drug: HRS-2129 Tablets, Drug: HRS-2129 Placebo, Drug: Pregabalin Capsules Placebo |
| HRS-2129 Low Dose Group | Experimental | Drug: HRS-2129 Tablets, Drug: HRS-2129 Placebo, Drug: Pregabalin Capsules Placebo |
| Pregabalin Group | Active comparator | Drug: HRS-2129 Placebo, Drug: Pregabalin Capsules |
| Blank Preparation Placebo Group | Placebo comparator | Drug: HRS-2129 Placebo, Drug: Pregabalin Capsules Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-2129 TabletsHRS-2129 tablets. | Drug | HRS-2129 High Dose Group, HRS-2129 Low Dose Group |
| HRS-2129 PlaceboHRS-2129 placebo. | Drug | Blank Preparation Placebo Group, HRS-2129 High Dose Group, HRS-2129 Low Dose Group, Pregabalin Group |
| Pregabalin CapsulesPregabalin capsules. | Drug | Pregabalin Group |
| Pregabalin Capsules PlaceboPregabalin capsules placebo. | Drug | Blank Preparation Placebo Group, HRS-2129 High Dose Group, HRS-2129 Low Dose Group |
Primary outcome
Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4.
Time frame: Baseline and 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.
9 secondary outcomes
Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline).
Time frame: Baseline and Week 4.
Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4.
Time frame: From Week 1 to Week 4.
Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4.
Time frame: 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.
Time frame: Baseline and Week 4.
Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4.
Time frame: At Week 4.
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4.
Time frame: Baseline and Week 4.
Number and severity of serious adverse events (SAEs).
Time frame: From Week 1 to Week 6.
Number and severity of adverse events (AEs).
Time frame: 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.
Time frame: From Day 0 to Day 30.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-2129 Tablets and Pregabalin Capsules in people with Diabetic Peripheral Neuropathic Pain, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Tang (+86-0518-82342973, lei.tang.lt31@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4. (time frame: Baseline and Week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.