A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
NCT ID: NCT06203002
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
496 participants
INTERVENTIONAL
2023-11-29
2025-02-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
NCT04455633
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
NCT06074562
Diabetic Peripheral Neuropathic Pain (DPNP)
NCT01314222
A Study for Treatment of Pain in Patients With Diabetic Neuropathy.
NCT00785577
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT03219320
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LX9211 Low Dose
LX9211 low dose, orally, once daily during a blinded treatment period.
LX9211 (blinded)
LX9211 (blinded) tablets
LX9211 High Dose
LX9211 high dose, orally, once daily during a blinded treatment period.
LX9211 (blinded)
LX9211 (blinded) tablets
LX9211 High Dose Followed by Low Dose
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
LX9211 (blinded)
LX9211 (blinded) tablets
LX9211 Placebo
LX9211 matching placebo, orally, once daily during a blinded treatment period.
Placebo (blinded)
LX9211 matching placebo tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo (blinded)
LX9211 matching placebo tablets
LX9211 (blinded)
LX9211 (blinded) tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lexicon Investigational Site (128)
Anniston, Alabama, United States
Lexicon Investigational Site (222)
Birmingham, Alabama, United States
Lexicon Investigational Site (189)
Daphne, Alabama, United States
Lexicon Investigational Site (215)
Guntersville, Alabama, United States
Lexicon Investigational Site (115)
Chandler, Arizona, United States
Lexicon Investigational Site (195)
Phoenix, Arizona, United States
Lexicon Investigational Site (206)
Scottsdale, Arizona, United States
Lexicon Investigational Site (102)
Tucson, Arizona, United States
Lexicon Investigational Site (107)
Anaheim, California, United States
Lexicon Investigational Site (173)
Canoga Park, California, United States
Lexicon Investigational Site (179)
Escondido, California, United States
Lexicon Investigational Site (161)
Fresno, California, United States
Lexicon Investigational Site (112)
Greenbrae, California, United States
Lexicon Investigational Site (204)
Huntington Beach, California, United States
Lexicon Investigational Site (191)
Inglewood, California, United States
Lexicon Investigational Site (163)
Lomita, California, United States
Lexicon Investigational Site (169)
Long Beach, California, United States
Lexicon Investigational Site (111)
Sacramento, California, United States
Lexicon Investigational Site (126)
Sacramento, California, United States
Lexicon Investigational Site (129)
San Diego, California, United States
Lexicon Investigational Site (154)
San Diego, California, United States
Lexicon Investigational Site (124)
Tustin, California, United States
Lexicon Investigational Site (211)
Vista, California, United States
Lexicon Investigational Site (171)
Walnut Creek, California, United States
Lexicon Investigational Site (181)
Walnut Creek, California, United States
Lexicon Investigational Site (119)
Brandon, Florida, United States
Lexicon Investigational Site (194)
Brandon, Florida, United States
Lexicon Investigational Site (177)
Daytona Beach, Florida, United States
Lexicon Investigational Site (198)
Fleming Island, Florida, United States
Lexicon Investigational Site (109)
Fort Myers, Florida, United States
Lexicon Investigational Site (180)
Hollywood, Florida, United States
Lexicon Investigational Site (188)
Jacksonville, Florida, United States
Lexicon Investigational Site (164)
Miami, Florida, United States
Lexicon Investigational Site (105)
New Port Richey, Florida, United States
Lexicon Investigational Site (146)
Orlando, Florida, United States
Lexicon Investigational Site (144)
Orlando, Florida, United States
Lexicon Investigational Site (123)
Ormond Beach, Florida, United States
Lexicon Investigational Site (182)
Plantation, Florida, United States
Lexicon Investigational Site (133)
The Villages, Florida, United States
Lexicon Investigational Site (138)
The Villages, Florida, United States
Lexicon Investigational Site (131)
Winter Haven, Florida, United States
Lexicon Investigational Site (103)
Winter Park, Florida, United States
Lexicon Investigational Site (150)
Atlanta, Georgia, United States
Lexicon Investigational Site (151)
Marietta, Georgia, United States
Lexicon Investigational Site (172)
Chicago, Illinois, United States
Lexicon Investigational Site (132)
Flossmoor, Illinois, United States
Lexicon Investigational Site (185)
El Dorado, Kansas, United States
Lexicon Investigational Site (178)
Newton, Kansas, United States
Lexicon Investigational Site (186)
Wichita, Kansas, United States
Lexicon Investigational Site (213)
Owensboro, Kentucky, United States
Lexicon Investigational Site (170)
New Orleans, Louisiana, United States
Lexicon Investigational Site (190)
New Orleans, Louisiana, United States
Lexicon Investigational Site (121)
Boston, Massachusetts, United States
Lexicon Investigational Site (140)
New Bedford, Massachusetts, United States
Lexicon Investigational Site (225)
Waltham, Massachusetts, United States
Lexicon Investigational Site (125)
Ann Arbor, Michigan, United States
Lexicon Investigational Site (108)
Dearborn, Michigan, United States
Lexicon Investigational Site (139)
Olive Branch, Mississippi, United States
Lexicon Investigational Site (104)
Hazelwood, Missouri, United States
Lexicon Investigational Site (174)
Kansas City, Missouri, United States
Lexicon Investigational Site (184)
Springfield, Missouri, United States
Lexicon Investigational Site (156)
St Louis, Missouri, United States
Lexicon Investigational Site (116)
Papillion, Nebraska, United States
Lexicon Investigational Site (216)
Las Vegas, Nevada, United States
Lexicon Investigational Site (162)
Las Vegas, Nevada, United States
Lexicon Investigational Site (142)
New York, New York, United States
Lexicon Investigational Site (227)
Rochester, New York, United States
Lexicon Investigational Site (167)
Schenectady, New York, United States
Lexicon Investigational Site (122)
Westfield, New York, United States
Lexicon Investigational Site (110)
Williamsville, New York, United States
Lexicon Investigational Site (200)
Asheville, North Carolina, United States
Lexicon Investigational Site (209)
Greensboro, North Carolina, United States
Lexicon Investigational Site (212)
Monroe, North Carolina, United States
Lexicon Investigational Site (106)
Morehead City, North Carolina, United States
Lexicon Investigational Site (145)
Winston-Salem, North Carolina, United States
Lexicon Investigational Site (220)
Beavercreek, Ohio, United States
Lexicon Investigational Site (168)
Dayton, Ohio, United States
Lexicon Investigational Site (148)
Norman, Oklahoma, United States
Lexicon Investigational Site (210)
Oklahoma City, Oklahoma, United States
Lexicon Investigational Site (187)
Eugene, Oregon, United States
Lexicon Investigational Site (183)
Charleston, South Carolina, United States
Lexicon Investigational Site (201)
Columbia, South Carolina, United States
Lexicon Investigational Site (113)
Greenville, South Carolina, United States
Lexicon Investigational Site (205)
North Charleston, South Carolina, United States
Lexicon Investigational Site (202)
Rock Hill, South Carolina, United States
Lexicon Investigational Site (157)
Summerville, South Carolina, United States
Lexicon Investigational Site (160)
Memphis, Tennessee, United States
Lexicon Investigational Site (192)
Austin, Texas, United States
Lexicon Investigational Site (199)
Baytown, Texas, United States
Lexicon Investigational Site (193)
Dallas, Texas, United States
Lexicon Investigational Site (158)
Dallas, Texas, United States
Lexicon Investigational Site (153)
Euless, Texas, United States
Lexicon Investigational Site (114)
Flower Mound, Texas, United States
Lexicon Investigational Site (196)
Harlingen, Texas, United States
Lexicon Investigational Site (120)
Houston, Texas, United States
Lexicon Investigational Site (197)
Houston, Texas, United States
Lexicon Investigational Site (152)
Houston, Texas, United States
Lexicon Investigational Site (214)
Katy, Texas, United States
Lexicon Investigational Site (155)
Lewisville, Texas, United States
Lexicon Investigational Site (223)
Mesquite, Texas, United States
Lexicon Investigational Site (203)
San Antonio, Texas, United States
Lexicon Investigational Site (159)
San Antonio, Texas, United States
Lexicon Investigational Site (221)
San Antonio, Texas, United States
Lexicon Investigational Site (101)
Salt Lake City, Utah, United States
Lexicon Investigational Site (219)
Salt Lake City, Utah, United States
Lexicon Investigational Site (224)
St. George, Utah, United States
Lexicon Investigational Site (130)
Manassas, Virginia, United States
Lexicon Investigational Site (165)
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LX9211.204-DPN
Identifier Type: OTHER
Identifier Source: secondary_id
LX9211.1-204-DPN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.