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

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: LX9211 (blinded); Drug: Placebo (blinded)

• Registration Number: NCT06203002
• Lead Sponsor: Lexicon Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-12
• Primary Completion: 2025-01-14
• Study Completion: 2025-02-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LX9211 High Dose	LX9211 (blinded)	LX9211 high dose, orally, once daily during a blinded treatment period.
LX9211 Placebo	Placebo (blinded)	LX9211 matching placebo, orally, once daily during a blinded treatment period.
LX9211 Low Dose	LX9211 (blinded)	LX9211 low dose, orally, once daily during a blinded treatment period.
LX9211 High Dose Followed by Low Dose	LX9211 (blinded)	LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)	Baseline, Week 8	ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score	Baseline, Week 8	NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.
Patient Global Impression of Change (PGIC) Score at Week 8	Week 8	The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.
Change from Baseline to Week 8 in Pain Interference on Sleep	Baseline, Week 8	Pain interference on sleep is based on the 11-point NRS (0 \[does not interfere\] to 10 \[completely interferes\]).
Change from Baseline to Week 8 in Burning Pain	Baseline, Week 8	Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).

Trial Locations

Locations (108)

Lexicon Investigational Site (128); 🇺🇸 Anniston, Alabama, United States

Lexicon Investigational Site (222); 🇺🇸 Birmingham, Alabama, United States

Lexicon Investigational Site (189); 🇺🇸 Daphne, Alabama, United States

Lexicon Investigational Site (215); 🇺🇸 Guntersville, Alabama, United States

Lexicon Investigational Site (115); 🇺🇸 Chandler, Arizona, United States

Lexicon Investigational Site (195); 🇺🇸 Phoenix, Arizona, United States

Lexicon Investigational Site (206); 🇺🇸 Scottsdale, Arizona, United States

Lexicon Investigational Site (102); 🇺🇸 Tucson, Arizona, United States

Lexicon Investigational Site (107); 🇺🇸 Anaheim, California, United States

Lexicon Investigational Site (173); 🇺🇸 Canoga Park, California, United States

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