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LX9211 high dose for Diabetic Neuropathy (RELIEF-DPN 1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Lexicon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 6

Summary

This trial is testing a new medication called LX9211 in different doses to see if it can reduce pain in people with nerve damage caused by diabetes over a few months.

Eligible Conditions
  • Diabetes
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Average Daily Pain Score (ADPS)
Secondary study objectives
Safety: # of AEs reported
≥30% reduction in pain intensity
≥50% reduction in pain intensity

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: LX9211 low doseExperimental Treatment1 Intervention
LX9211, once daily
Group II: LX9211 high doseExperimental Treatment1 Intervention
LX9211, once daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LX9211 high dose
2020
Completed Phase 2
~320
LX9211 low dose
2020
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

Lexicon PharmaceuticalsLead Sponsor
66 Previous Clinical Trials
24,115 Total Patients Enrolled
Suman Wason, MDStudy DirectorLexicon Pharmaceuticals
25 Previous Clinical Trials
16,513 Total Patients Enrolled
Suma Gopinathan, PhDStudy DirectorLexicon Pharmaceuticals
1 Previous Clinical Trials
79 Total Patients Enrolled
~60 spots leftby Nov 2025
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