A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Last updated: May 7, 2025
Sponsor: Lexicon Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Pain

Pain (Pediatric)

Treatment

LX9211 (blinded)

Placebo (blinded)

Clinical Study ID

NCT06203002
LX9211.1-204-DPN
LX9211.204-DPN
  • Ages > 18
  • All Genders

Study Summary

Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant has given written informed consent to participate in the study inaccordance 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) withchronic 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

Exclusion Criteria:

  1. Presence of other painful conditions that may confound assessment or self-evaluationof 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 theScreening Visit.

  4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathicpain within 3 months prior to Screening

  5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior toScreening

Study Design

Total Participants: 496
Treatment Group(s): 2
Primary Treatment: LX9211 (blinded)
Phase: 2
Study Start date:
November 29, 2023
Estimated Completion Date:
February 24, 2025

Connect with a study center

  • Lexicon Investigational Site (128)

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Lexicon Investigational Site (222)

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Lexicon Investigational Site (189)

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Lexicon Investigational Site (215)

    Guntersville, Alabama 35976
    United States

    Site Not Available

  • Lexicon Investigational Site (115)

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Lexicon Investigational Site (195)

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Lexicon Investigational Site (206)

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Lexicon Investigational Site (102)

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Lexicon Investigational Site (107)

    Anaheim, California 92801
    United States

    Site Not Available

  • Lexicon Investigational Site (173)

    Canoga Park, California 91303
    United States

    Site Not Available

  • Lexicon Investigational Site (179)

    Escondido, California 92025
    United States

    Site Not Available

  • Lexicon Investigational Site (161)

    Fresno, California 93710
    United States

    Site Not Available

  • Lexicon Investigational Site (112)

    Greenbrae, California 94904
    United States

    Site Not Available

  • Lexicon Investigational Site (204)

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Lexicon Investigational Site (191)

    Inglewood, California 90301
    United States

    Site Not Available

  • Lexicon Investigational Site (171)

    Lafayette, California 94549
    United States

    Site Not Available

  • Lexicon Investigational Site (163)

    Lomita, California 90717
    United States

    Site Not Available

  • Lexicon Investigational Site (169)

    Long Beach, California 90806
    United States

    Site Not Available

  • Lexicon Investigational Site (111)

    Sacramento, California 95821
    United States

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  • Lexicon Investigational Site (126)

    Sacramento, California 95821
    United States

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  • Lexicon Investigational Site (129)

    San Diego, California 92103
    United States

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  • Lexicon Investigational Site (154)

    San Diego, California 92120
    United States

    Site Not Available

  • Lexicon Investigational Site (137)

    Santa Ana, California 92703
    United States

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  • Lexicon Investigational Site (124)

    Tustin, California 92780
    United States

    Site Not Available

  • Lexicon Investigational Site (211)

    Vista, California 92081
    United States

    Site Not Available

  • Lexicon Investigational Site (181)

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Lexicon Investigational Site (119)

    Brandon, Florida 33511
    United States

    Site Not Available

  • Lexicon Investigational Site (194)

    Brandon, Florida 33511
    United States

    Site Not Available

  • Lexicon Investigational Site (177)

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Lexicon Investigational Site (198)

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Lexicon Investigational Site (109)

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Lexicon Investigational Site (109)

    Ft. Myers, Florida 33912
    United States

    Site Not Available

  • Lexicon Investigational Site (180)

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Lexicon Investigational Site (188)

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Lexicon Investigational Site (164)

    Miami, Florida 33176
    United States

    Site Not Available

  • Lexicon Investigational Site (105)

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Lexicon Investigational Site (144)

    Orlando, Florida 32806
    United States

    Site Not Available

  • Lexicon Investigational Site (146)

    Orlando, Florida 32801
    United States

    Site Not Available

  • Lexicon Investigational Site (123)

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Lexicon Investigational Site (123)

    Ormond Beach,, Florida 32174
    United States

    Site Not Available

  • Lexicon Investigational Site (182)

    Plantation, Florida 33317
    United States

    Site Not Available

  • Lexicon Investigational Site (133)

    The Villages, Florida 32159
    United States

    Site Not Available

  • Lexicon Investigational Site (138)

    The Villages, Florida 32162
    United States

    Site Not Available

  • Lexicon Investigational Site (131)

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Lexicon Investigational Site (103)

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Lexicon Investigational Site (150)

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Lexicon Investigational Site (151)

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Lexicon Investigational Site (136)

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Lexicon Investigational Site (172)

    Berwyn, Illinois 60402
    United States

    Site Not Available

  • Lexicon Investigational Site (132)

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Lexicon Investigational Site (185)

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • Lexicon Investigational Site (178)

    Newton, Kansas 67114
    United States

    Site Not Available

  • Lexicon Investigational Site (186)

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Lexicon Investigational Site (213)

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Lexicon Investigational Site (170)

    New Orleans, Louisiana 70115
    United States

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  • Lexicon Investigational Site (190)

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Lexicon Investigational Site (121)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Lexicon Investigational Site (140)

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • Lexicon Investigational Site (225)

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Lexicon Investigational Site (125)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Lexicon Investigational Site (108)

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Lexicon Investigational Site (139)

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Lexicon Investigational Site (104)

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Lexicon Investigational Site (174)

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Lexicon Investigational Site (156)

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Lexicon Investigational Site (184)

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Lexicon Investigational Site (116)

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Lexicon Investigational Site (162)

    Las Vegas, Nevada 89123
    United States

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  • Lexicon Investigational Site (216)

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Lexicon Investigational Site (142)

    New York, New York 100029
    United States

    Site Not Available

  • Lexicon Investigational Site (227)

    Rochester, New York 14609
    United States

    Site Not Available

  • Lexicon Investigational Site (167)

    Schenectady, New York 12304
    United States

    Site Not Available

  • Lexicon Investigational Site (122)

    Westfield, New York 14787
    United States

    Site Not Available

  • Lexicon Investigational Site (110)

    Williamsville, New York 14221
    United States

    Site Not Available

  • Lexicon Investigational Site (200)

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Lexicon Investigational Site (209)

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Lexicon Investigational Site (212)

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Lexicon Investigational Site (106)

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lexicon Investigational Site (145)

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lexicon Investigational Site (220)

    Beavercreek, Ohio 45432
    United States

    Site Not Available

  • Lexicon Investigational Site (168)

    Dayton, Ohio 45424
    United States

    Site Not Available

  • Lexicon Investigational Site (148)

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Lexicon Investigational Site (210)

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Lexicon Investigational Site (187)

    Eugene, Oregon 97404
    United States

    Site Not Available

  • Lexicon Investigational Site (183)

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Lexicon Investigational Site (201)

    Columbia, South Carolina 29205
    United States

    Site Not Available

  • Lexicon Investigational Site (113)

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Lexicon Investigational Site (205)

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Lexicon Investigational Site (202)

    Rock Hill, South Carolina 29730
    United States

    Site Not Available

  • Lexicon Investigational Site (157)

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Lexicon Investigational Site (160)

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Lexicon Investigational Site (192)

    Austin, Texas 78759
    United States

    Site Not Available

  • Lexicon Investigational Site (199)

    Baytown, Texas 77521
    United States

    Site Not Available

  • Lexicon Investigational Site (158)

    Dallas, Texas 75231
    United States

    Site Not Available

  • Lexicon Investigational Site (193)

    Dallas, Texas 75230
    United States

    Site Not Available

  • Lexicon Investigational Site (153)

    Euless, Texas 76040
    United States

    Site Not Available

  • Lexicon Investigational Site (114)

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Lexicon Investigational Site (196)

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Lexicon Investigational Site (120)

    Houston, Texas 77030
    United States

    Site Not Available

  • Lexicon Investigational Site (152)

    Houston, Texas 77074
    United States

    Site Not Available

  • Lexicon Investigational Site (197)

    Houston, Texas 77065
    United States

    Site Not Available

  • Lexicon Investigational Site (214)

    Katy, Texas 77494
    United States

    Site Not Available

  • Lexicon Investigational Site (155)

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Lexicon Investigational Site (223)

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Lexicon Investigational Site (159)

    San Antonio, Texas 78233
    United States

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  • Lexicon Investigational Site (203)

    San Antonio, Texas 78229
    United States

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  • Lexicon Investigational Site (221)

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Lexicon Investigational Site (224)

    Saint George, Utah 84790
    United States

    Site Not Available

  • Lexicon Investigational Site (101)

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Lexicon Investigational Site (219)

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Lexicon Investigational Site (224)

    St. George, Utah 84790
    United States

    Site Not Available

  • Lexicon Investigational Site (130)

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Lexicon Investigational Site (165)

    Norfolk, Virginia 23510
    United States

    Site Not Available

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