Not Yet RecruitingPhase 2

Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain

180 participantsStarted 2025-09

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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).

What they're measuring

Change in average daily pain score (ADPS) from baseline after 12 weeks of administration

Timeframe: From baseline to the end of treatment at 12 weeks

Trial details

NCT IDNCT07159243

SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Yanfang Feng

+86 21 64311017 feng_yanfang@hllife.com.cn

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathic Pain trials