LX9211 for Diabetic Neuropathy

(PROGRESS Trial)

Recruiting at 109 trial locations

Overseen By Tracy Newbold

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Lexicon Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called LX9211 to see if it can reduce nerve pain in people with diabetes. The drug works by blocking pain signals in the nerves. Researchers want to find out if it is more effective than other treatments. A similar drug was previously tested for similar conditions but its development was halted due to safety concerns.

Eligibility Criteria

Adults over 18 with a BMI between 18.0 and 40.0 kg/m^2, diagnosed with type 1 or type 2 diabetes and suffering from chronic diabetic peripheral neuropathic pain for at least six months can join this study. They must have stable diabetes management for three months and an A1C level of ≤11%. People using opioids, neurolytic therapies, topical analgesics for neuropathy recently, or NSAIDs within two weeks cannot participate.

Inclusion Criteria

Willing to adhere to the prohibitions and restrictions specified in the protocol.

I have diabetes (type 1 or 2) with chronic nerve pain.

I am 18 years old or older.

Exclusion Criteria

I have other painful conditions besides diabetic peripheral neuropathic pain.

I haven't used prescription creams for nerve pain in the last 3 months.

I have had nerve treatment or surgery for diabetic nerve pain.

Treatment Details

Interventions

• LX9211 (Other)
• Placebo (Other)

Trial Overview The trial is testing the effectiveness of a new medication called LX9211 against a placebo in reducing pain caused by diabetic peripheral neuropathy. Participants won't know if they're receiving the actual drug or the placebo as both are blinded.

Participant Groups

Group I: LX9211 Low Dose Experimental Treatment 1 Intervention

LX9211 low dose, orally, once daily during a blinded treatment period.

Group II: LX9211 High Dose Followed by Low Dose Experimental Treatment 1 Intervention

LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Group III: LX9211 High Dose Experimental Treatment 1 Intervention

LX9211 high dose, orally, once daily during a blinded treatment period.

Group IV: LX9211 Placebo Placebo Group 1 Intervention

LX9211 matching placebo, orally, once daily during a blinded treatment period.

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