319 Participants Needed

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

(RELIEF-DPN 1 Trial)

Recruiting at 55 trial locations
CW
Overseen ByChristopher Warner, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use opioid medications for DPNP within 2 months before the screening or NSAIDs less than 2 weeks before the screening.

What is the purpose of this trial?

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.

Research Team

SG

Suma Gopinathan, PhD

Principal Investigator

Lexicon Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Patient has given written informed consent to participate in the study in accordance with local regulations
Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
Diagnosis of DPNP at Screening
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low or high dose of LX9211 or placebo once daily

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

Treatment Details

Interventions

  • LX9211
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: LX9211 200 mg/20 mgExperimental Treatment1 Intervention
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
Group II: LX9211 100 mg/10 mgExperimental Treatment1 Intervention
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
Group III: PlaceboPlacebo Group1 Intervention
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lexicon Pharmaceuticals

Lead Sponsor

Trials
67
Recruited
24,400+

Dr. Mike Exton

Lexicon Pharmaceuticals

Chief Executive Officer

PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany

Dr. Craig Granowitz

Lexicon Pharmaceuticals

Chief Medical Officer since 2021

MD

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