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

NCT04455633 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2025-06-25

Study results available
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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

DRUG

LX9211

Oral Tablets

DRUG

LX9211 Matching Placebo

Oral Tablets

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suma Gopinathan, PhD · Lexicon Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2022-05-23
Completion
2022-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455633 on ClinicalTrials.gov