Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT04455633
Last Updated: 2025-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
319 participants
INTERVENTIONAL
2020-09-03
2022-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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.
LX9211 Matching Placebo
Oral Tablets
LX9211 100 mg/10 mg
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.
LX9211
Oral Tablets
LX9211 200 mg/20 mg
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.
LX9211
Oral Tablets
Interventions
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LX9211
Oral Tablets
LX9211 Matching Placebo
Oral Tablets
Eligibility Criteria
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Inclusion Criteria
* Adult male and female participants ≥18 years of age at the time of screening
* Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
* Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
* Pain from DPN present for at least 6 months
* Haemoglobin A1C ≤11% at screening
* Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
Exclusion Criteria
* History of major depressive episode, active, significant psychiatric disorders
* History of clinically significant drug or alcohol use disorder
* History of neurolytic or neurosurgical therapy for DPNP
* Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
18 Years
ALL
No
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Suma Gopinathan, PhD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals
Locations
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Lexicon Investigational Site
Mobile, Alabama, United States
Lexicon Investigational Site
Chandler, Arizona, United States
Lexicon Investigational Site
Glendale, Arizona, United States
Lexicon Investigational Site
Kingman, Arizona, United States
Lexicon Investigational Site
Tucson, Arizona, United States
Lexicon Investigational Site
Anaheim, California, United States
Lexicon Investigational Site
Greenbrae, California, United States
Lexicon Investigational Site
Los Angeles, California, United States
Lexicon Investigational Site
North Hollywood, California, United States
Lexicon Investigational Site
Sacramento, California, United States
Lexicon Investigational Site
Tustin, California, United States
Lexicon Investigational Site
Brandon, Florida, United States
Lexicon Investigational Site
Fort Myers, Florida, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
Lake City, Florida, United States
Lexicon Investigational Site
New Port Richey, Florida, United States
Lexicon Investigational Site
Ormond Beach, Florida, United States
Lexicon Investigational Site
Winter Park, Florida, United States
Lexicon Investigational Site
Macon, Georgia, United States
Lexicon Investigational Site
Evansville, Indiana, United States
Lexicon Investigational Site
Boston, Massachusetts, United States
Lexicon Investigational Site
South Dartmouth, Massachusetts, United States
Lexicon Investigational Site
Ann Arbor, Michigan, United States
Lexicon Investigational Site
Dearborn, Michigan, United States
Lexicon Investigational Site
Farmington Hills, Michigan, United States
Lexicon Investigational Site
Sterling Heights, Michigan, United States
Lexicon Investigational Site
Hazelwood, Missouri, United States
Lexicon Investigational Site
Omaha, Nebraska, United States
Lexicon Investigational Site
Berlin, New Jersey, United States
Lexicon Investigational Site
Westfield, New York, United States
Lexicon Investigational Site
Williamsville, New York, United States
Lexicon Investigational Site
Asheville, North Carolina, United States
Lexicon Investigational Site
Cary, North Carolina, United States
Lexicon Investigational Site
Morehead City, North Carolina, United States
Lexicon Investigational Site
Greenville, South Carolina, United States
Lexicon Investigational Site
Austin, Texas, United States
Lexicon Investigational Site
Austin, Texas, United States
Lexicon Investigational Site
Dallas, Texas, United States
Lexicon Investigational Site
Flower Mound, Texas, United States
Lexicon Investigational Site
Houston, Texas, United States
Lexicon Investigational Site
Houston, Texas, United States
Lexicon Investigational Site
Pearland, Texas, United States
Lexicon Investigational Site
Salt Lake City, Utah, United States
Lexicon Investigational Site
Renton, Washington, United States
Countries
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References
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Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LX9211.201
Identifier Type: OTHER
Identifier Source: secondary_id
LX9211.1-201-DPN
Identifier Type: -
Identifier Source: org_study_id
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