NCT04455633

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.

Conditions

• Diabetic Peripheral Neuropathy
• Diabetes

Interventions

Type	Name	Description
DRUG	LX9211	Oral Tablets
DRUG	LX9211 Matching Placebo	Oral Tablets

Timeline

• Start date: 2020-09-03
• Primary completion: 2022-05-23
• Completion: 2022-06-28
• First posted: 2020-07-02
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study