Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain

Conditions
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Diabetic Peripheral Neuropathy, Diabetes

Intervention / Treatment
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* Drug: LX9211 low dose
* Drug: LX9211 high dose
* Drug: LX9211 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has given written informed consent to participate in the study in accordance with local regulations Adult male and female patients ≥18 years of age at the time of screening Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening Diagnosis of DPNP at Screening Pain from DPN present for at least 6 months A1C ≤11% at screening Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening Exclusion Criteria: Presence of other painful conditions that may confound assessment or self-evaluation of DPNP History of major depressive episode, active, significant psychiatric disorders History of clinically significant drug or alcohol use disorder History of neurolytic or neurosurgical therapy for DPNP Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit Use of NSAIDs less than 2 weeks prior to the Screening Visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LX9211 low dose<br>LX9211, once daily | Drug: LX9211 low dose<br>* 11-week assessment period<br>|
| Experimental: LX9211 high dose<br>LX9211, once daily | Drug: LX9211 high dose<br>* 11-week assessment period<br>|
| Placebo Comparator: Placebo<br>Placebo, once daily | Drug: LX9211 Placebo<br>* 11-week assessment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Average Daily Pain Score (ADPS) | The change from Baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS) (0 [no pain] to 10 [worst imaginable pain]) | Day 1 to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥30% reduction in pain intensity | Proportion of patients with ≥30% reduction in pain intensity | Day 1 to Week 6 | 
| ≥50% reduction in pain intensity | Proportion of patients with ≥50% reduction in pain intensity | Day 1 to Week 6 | 
| Safety: # of AEs reported | # of Adverse Events | Day 1 to Week 6 |