CompletedPhase 2

A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

United States496 participantsStarted 2023-11-29

Plain-language summary

Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/

Age range18 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.

✓. Participant has given written informed consent to participate in the study in accordance with local regulations
✓. Adult male and female participants ≥18 years of age at the Screening Visit
✓. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
✓. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
✓. Pain from DPNP present for at least 6 months prior to Screening
✓. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
✓. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
✓. Willing to adhere to the prohibitions and restrictions specified in the protocol.

✕. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
✕. History of neurolytic or neurosurgical therapy for DPNP
✕. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
✕. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
✕. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening

Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)

Timeframe: Baseline, Week 8

NCT IDNCT06203002

SponsorLexicon Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-14

Who can participate

Age range18 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.

✓. Participant has given written informed consent to participate in the study in accordance with local regulations
✓. Adult male and female participants ≥18 years of age at the Screening Visit
✓. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
✓. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
✓. Pain from DPNP present for at least 6 months prior to Screening
✓. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
✓. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
✓. Willing to adhere to the prohibitions and restrictions specified in the protocol.

✕. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
✕. History of neurolytic or neurosurgical therapy for DPNP
✕. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
✕. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
✕. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening