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New pill HRS-2129 aims to ease diabetic nerve pain

NCT ID NCT07377721

Symptom relief Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called HRS-2129 in 168 Chinese adults with diabetic peripheral neuropathic pain (nerve pain from diabetes). Participants will receive either HRS-2129, a placebo, or the standard drug pregabalin to see if HRS-2129 reduces pain better than placebo. The trial is early-stage (Phase 1) and focuses on safety and pain relief over 4 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-2129
What this could lead to
If it works, this could point toward a new treatment option for diabetic nerve pain.
What could go wrong
This is an early Phase 1 study with only 168 participants, so results may not apply broadly. The drug may not prove more effective than existing treatments or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathic pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

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