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

(RELIEF-DPN 1 Trial)

Recruiting at 55 trial locations

Overseen By Christopher Warner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lexicon Pharmaceuticals

Must not be taking: Opioids, NSAIDs

Disqualifiers: Other painful conditions, Major depression, Drug/alcohol disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

319 Participants Needed

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

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

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

Group I: LX9211 200 mg/20 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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: Placebo Placebo Group 1 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.

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