Diabetic Peripheral Neuropathic PainPhase 2NCT07159243
Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing HL-1186 in people with Diabetic Peripheral Neuropathic Pain, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd..
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- HL-1186
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2026
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old (inclusive), regardless of gender.
- With Type 1 or Type 2 diabetes mellitus, with a diagnosis of DPNP for at least 6 months.
- Screening period: ADPS ranging from 4 to 9 points, and Visual Analog Scale (VAS) scores of 40mm - 90mm in two different days.
- The hypoglycemic regimen has been stable for at least 4 weeks before enrollment, and the glycated hemoglobin (HbA1c) during the screening period is ≤ 9%.
- Participants fully understand the purpose, characteristics, methods of the trial and possible adverse events, voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Participants with any pain other than DPNP, or with other diseases that the investigator deems may affect the evaluation of DPNP.
- Participants who are allergic to the active ingredients or excipients of HL-1186, HL-1186 placebo, or paracetamol tablets, or who have an allergic constitution, or have a history of allergies to ≥ 3 substances.
- Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with DPNP.
- Participants who used any prohibited drugs within 2 weeks before screening (or within 5 half-lives after the last use of such prohibited drugs at the time of screening, whichever is longer).
- Participants who had acute diabetic complications within 6 months before screening, such as diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, acute severe hypoglycemia, etc., or had lower limb amputation (except toe amputation) at the time of screening.
- Participants with clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period (such as QTcF ≥ 450ms), or with severe cardiopulmonary diseases that the investigator deems inappropriate for inclusion, such as unstable angina pectoris, myocardial infarction, severe arrhythmias requiring treatment (such as grade Ⅲ atrioventricular block), NYHA cardiac function class ≥ Ⅲ, poorly controlled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg), recurrent asthma, etc.
Show all 15Show fewer
- Participants with neuropsychiatric system diseases that the investigator deems may affect the participant's evaluation of DPNP or scale evaluation, such as depression, anxiety, epilepsy, recurrent dizziness, memory and cognitive impairment, a history of suicide attempts or suicidal tendencies, etc.
- Participants with a history of malignant tumors within 2 years before screening (except for participants with basal cell carcinoma, squamous cell carcinoma, and stage 0 cervical carcinoma in situ that have been confirmed cured by the investigator).
- Participants with clinically significant and unstable diseases of the nervous system, mental system, ophthalmology, hepatobiliary system, respiratory system, hematological system, or cardiovascular system within 1 year before screening, and the investigator assesses that such diseases may endanger the participant's safety during the trial, restrict the participant from completing the study procedures, or affect the research purpose.
- Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA > ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA > ULN.
- Participants with a history of alcoholism or drug abuse within 2 years before screening.
- Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.
- Participants of childbearing potential who have plans to conceive, freeze or donate sperm/eggs from the time of signing the informed consent form until 6 months after the last dose, or who refuse to adopt effective contraceptive measures (complete abstinence, barrier methods, contraceptives, intrauterine devices, or having undergone sterilization surgery).
- Participants who have participated in other drug or medical device trials within 3 months before screening or are currently participating in other clinical trials.
- Participants deemed by the investigator to be unsuitable for participating in this study for any reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-designed Clinical Study to Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain
This is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- HL-1186, HL-1186 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-1186Drug
HL-1186 tablet for oral administration.
HL-1186Drug
HL-1186 tablet for oral administration.
HL-1186 placeboDrug
HL-1186 placebo tablet for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| HL-1186 Group 1 | Experimental | Each participant will receive HL-1186 for 12 weeks. Receives: Drug: HL-1186 |
| HL-1186 Group 2 | Experimental | Each participant will receive HL-1186 for 12 weeks. Receives: Drug: HL-1186 |
| HL-1186 Placebo | Placebo comparator | Each participant will receive a matching placebo for 12 weeks. Receives: Drug: HL-1186 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily pain score (ADPS) from baseline after 12 weeks of administration
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing the worst pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Measured: From baseline to the end of treatment at 12 weeks
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From first day of administration to the end of the last follow-up at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159243
- Sponsor's protocol ID
- PY-HL-1186-II-01
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-designed Clinical Study to Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07159243
- Acronym / sponsor ID
- PY-HL-1186-II-01
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Sep 2025 (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 is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HL-1186 Group 1 | Experimental | Drug: HL-1186Each participant will receive HL-1186 for 12 weeks. |
| HL-1186 Group 2 | Experimental | Drug: HL-1186Each participant will receive HL-1186 for 12 weeks. |
| HL-1186 Placebo | Placebo comparator | Drug: HL-1186 placeboEach participant will receive a matching placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years old (inclusive), regardless of gender.
- With Type 1 or Type 2 diabetes mellitus, with a diagnosis of DPNP for at least 6 months.
- Screening period: ADPS ranging from 4 to 9 points, and Visual Analog Scale (VAS) scores of 40mm - 90mm in two different days.
- The hypoglycemic regimen has been stable for at least 4 weeks before enrollment, and the glycated hemoglobin (HbA1c) during the screening period is ≤ 9%.
- Participants fully understand the purpose, characteristics, methods of the trial and possible adverse events, voluntarily participate in the trial and sign the informed consent form.
Key exclusion criteria (15 listed)
- Participants with any pain other than DPNP, or with other diseases that the investigator deems may affect the evaluation of DPNP.
- Participants who are allergic to the active ingredients or excipients of HL-1186, HL-1186 placebo, or paracetamol tablets, or who have an allergic constitution, or have a history of allergies to ≥ 3 substances.
- Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with DPNP.
- Participants who used any prohibited drugs within 2 weeks before screening (or within 5 half-lives after the last use of such prohibited drugs at the time of screening, whichever is longer).
- Participants who had acute diabetic complications within 6 months before screening, such as diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, acute severe hypoglycemia, etc., or had lower limb amputation (except toe amputation) at the time of screening.
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 |
|---|---|---|
| HL-1186HL-1186 tablet for oral administration. | Drug | HL-1186 Group 1 |
| HL-1186HL-1186 tablet for oral administration. | Drug | HL-1186 Group 2 |
| HL-1186 placeboHL-1186 placebo tablet for oral administration. | Drug | HL-1186 Placebo |
Primary outcome
Change in average daily pain score (ADPS) from baseline after 12 weeks of administration
Time frame: From baseline to the end of treatment at 12 weeks
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing the worst pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From first day of administration to the end of the last follow-up at Week 16
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 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathic Pain
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL-1186 in people with Diabetic Peripheral Neuropathic Pain, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd..
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 15 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yanfang Feng (+86 21 64311017, feng_yanfang@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily pain score (ADPS) from baseline after 12 weeks of administration (time frame: From baseline to the end of treatment at 12 weeks). 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 8 Sep 2025.