A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Launched by LEXICON PHARMACEUTICALS · Jan 2, 2024
Trial Information
Current as of July 08, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is examining a medication called LX9211 to see if it can help reduce pain caused by diabetic peripheral neuropathic pain (DPNP), a common issue for people with diabetes. The study is currently active but not recruiting new participants. It is open to adults aged 18 and older who have been diagnosed with either type 1 or type 2 diabetes and have been experiencing DPNP pain for at least six months. To participate, individuals need to have a stable diabetes treatment plan and meet certain health criteria, such as having a specific body weight range and controlled blood sugar levels.
Participants in this study will take either LX9211 or a placebo (a dummy treatment with no active medicine) to compare the effects on their pain. They will be required to follow some guidelines during the trial and will be monitored closely for their health and well-being. It's important to note that individuals with other painful conditions or those who have recently used certain pain medications may not be eligible for this trial. For more details, you can visit the study’s website at https://diabeticpainstudy.com/.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participant has given written informed consent to participate in the study in accordance with local regulations
- • 2. Adult male and female participants ≥18 years of age at the Screening Visit
- • 3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
- • 4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
- • 5. Pain from DPNP present for at least 6 months prior to Screening
- • 6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
- • 7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
- • 8. Willing to adhere to the prohibitions and restrictions specified in the protocol.
- Exclusion Criteria:
- • 1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- • 2. History of neurolytic or neurosurgical therapy for DPNP
- • 3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
- • 4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
- • 5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
About Lexicon Pharmaceuticals
Lexicon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery and development of innovative therapies for the treatment of serious diseases. With a strong focus on leveraging its unique gene-targeted technology platform, Lexicon aims to identify and develop novel drug candidates that address unmet medical needs across various therapeutic areas, including metabolic and autoimmune disorders. Committed to scientific excellence and patient-centered solutions, Lexicon collaborates with leading research institutions and healthcare professionals to advance its pipeline of clinical programs, ultimately striving to improve patient outcomes and enhance quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Port Richey, Florida, United States
Tucson, Arizona, United States
Anaheim, California, United States
Greenbrae, California, United States
Sacramento, California, United States
Winter Park, Florida, United States
Dearborn, Michigan, United States
Hazelwood, Missouri, United States
Morehead City, North Carolina, United States
Salt Lake City, Utah, United States
Sacramento, California, United States
Brandon, Florida, United States
Westfield, New York, United States
Williamsville, New York, United States
Houston, Texas, United States
Manassas, Virginia, United States
Anniston, Alabama, United States
Daphne, Alabama, United States
Fresno, California, United States
Lafayette, California, United States
Tustin, California, United States
Fort Myers, Florida, United States
Hollywood, Florida, United States
Ormond Beach, Florida, United States
The Villages, Florida, United States
Woodstock, Georgia, United States
Flossmoor, Illinois, United States
Newton, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Kansas City, Missouri, United States
Winston Salem, North Carolina, United States
Norman, Oklahoma, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Lomita, California, United States
Long Beach, California, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Winter Haven, Florida, United States
Marietta, Georgia, United States
El Dorado, Kansas, United States
Olive Branch, Mississippi, United States
Springfield, Missouri, United States
Las Vegas, Nevada, United States
Eugene, Oregon, United States
Summerville, South Carolina, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Flower Mound, Texas, United States
Harlingen, Texas, United States
Lewisville, Texas, United States
Birmingham, Alabama, United States
Chandler, Arizona, United States
Scottsdale, Arizona, United States
Canoga Park, California, United States
Escondido, California, United States
Huntington Beach, California, United States
Inglewood, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Walnut Creek, California, United States
Plantation, Florida, United States
The Villages, Florida, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New Bedford, Massachusetts, United States
Papillion, Nebraska, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Monroe, North Carolina, United States
North Charleston, South Carolina, United States
Baytown, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Guntersville, Alabama, United States
Brandon, Florida, United States
Fleming Island, Florida, United States
Berwyn, Illinois, United States
Owensboro, Kentucky, United States
Waltham, Massachusetts, United States
Las Vegas, Nevada, United States
Schenectady, New York, United States
Greensboro, North Carolina, United States
Beavercreek, Ohio, United States
Dayton, Ohio, United States
Columbia, South Carolina, United States
Rock Hill, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Katy, Texas, United States
Mesquite, Texas, United States
Saint George, Utah, United States
Phoenix, Arizona, United States
Vista, California, United States
Atlanta, Georgia, United States
Ann Arbor, Michigan, United States
Oklahoma City, Oklahoma, United States
Euless, Texas, United States
Saint Louis, Missouri, United States
New York, New York, United States
San Antonio, Texas, United States
Ft. Myers, Florida, United States
Ormond Beach,, Florida, United States
St. George, Utah, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported