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

Last updated: October 8, 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

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    Birmingham, Alabama 35216
    United States

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    Daphne, Alabama 36526
    United States

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    Guntersville, Alabama 35976
    United States

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    Anniston 4830198, Alabama 4829764 36207
    United States

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    Birmingham 4049979, Alabama 4829764 35216
    United States

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  • Lexicon Investigational Site (189)

    Daphne 4058219, Alabama 4829764 36526
    United States

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    Guntersville 4065649, Alabama 4829764 35976
    United States

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    Chandler, Arizona 85286
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    Phoenix, Arizona 85028
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    Scottsdale, Arizona 85258
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    Tucson, Arizona 85741
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    Chandler 5289282, Arizona 5551752 85286
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    Phoenix 5308655, Arizona 5551752 85028
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    Scottsdale 5313457, Arizona 5551752 85258
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    Tucson 5318313, Arizona 5551752 85741
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    Anaheim, California 92801
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    Canoga Park, California 91303
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    Escondido, California 92025
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    Fresno, California 93710
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    Greenbrae, California 94904
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    Huntington Beach, California 92647
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    Lafayette, California 94549
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    Lomita, California 90717
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    Long Beach, California 90806
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    Sacramento, California 95821
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    San Diego, California 92120
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    Santa Ana, California 92703
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    Tustin, California 92780
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    Vista, California 92081
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    Walnut Creek, California 94598
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    Escondido 5346827, California 5332921 92025
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    Tustin 5404119, California 5332921 92780
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    Vista 5406602, California 5332921 92081
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    Walnut Creek 5406990, California 5332921 94596
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    Walnut Creek 5406990, California 5332921 94598
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    Brandon, Florida 33511
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    Brandon, Florida 33511
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    Daytona Beach, Florida 32117
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    Fleming Island, Florida 32003
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    New Port Richey, Florida 34652
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    Ormond Beach, Florida 32174
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    Plantation, Florida 33317
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    Winter Haven, Florida 33880
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    Winter Park, Florida 32789
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    Brandon 4148757, Florida 4155751 33511
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    Daytona Beach 4152872, Florida 4155751 32117
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    Fleming Island 4155594, Florida 4155751 32003
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    Fort Myers 4155995, Florida 4155751 33912
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    Hollywood 4158928, Florida 4155751 33024
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    Miami 4164138, Florida 4155751 33176
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    New Port Richey 4165869, Florida 4155751 34652
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    Orlando 4167147, Florida 4155751 32806
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    Orlando 4167147, Florida 4155751 32801
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    Plantation 4168782, Florida 4155751 33317
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    The Villages 4175179, Florida 4155751 32159
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    The Villages 4175179, Florida 4155751 32162
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    Winter Haven 4178552, Florida 4155751 33880
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    Winter Park 4178560, Florida 4155751 32789
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    Atlanta, Georgia 30303
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    Marietta, Georgia 30060
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    Woodstock, Georgia 30189
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    Atlanta 4180439, Georgia 4197000 30303
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    Marietta 4207783, Georgia 4197000 30060
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    Berwyn, Illinois 60402
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    Flossmoor, Illinois 60422
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    Berwyn 4884597, Illinois 4896861 60402
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    Chicago 4887398, Illinois 4896861 60623
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    Flossmoor 4892684, Illinois 4896861 60422
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    El Dorado, Kansas 67042
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    Newton, Kansas 67114
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    Wichita, Kansas 67207
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    El Dorado 4270863, Kansas 4273857 67042
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    Newton 4276248, Kansas 4273857 67114
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    Wichita 4281730, Kansas 4273857 67207
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    Owensboro, Kentucky 42303
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    Owensboro 4303436, Kentucky 6254925 42303
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    New Orleans, Louisiana 70115
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    New Orleans, Louisiana 70119
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    New Orleans 4335045, Louisiana 4331987 70115
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    New Bedford, Massachusetts 02740
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    Waltham, Massachusetts 02451
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    Boston 4930956, Massachusetts 6254926 02115
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    New Bedford 4945121, Massachusetts 6254926 02740
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    Waltham 4954380, Massachusetts 6254926 02451
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    Ann Arbor, Michigan 48109
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    Dearborn, Michigan 48126
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    Ann Arbor 4984247, Michigan 5001836 48109
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    Dearborn 4990510, Michigan 5001836 48126
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    Olive Branch, Mississippi 38654
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    Olive Branch 4439869, Mississippi 4436296 38654
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    Hazelwood, Missouri 63042
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    Kansas City, Missouri 64114
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    Saint Louis, Missouri 63110
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    Springfield, Missouri 65807
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    Papillion, Nebraska 68046
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    Papillion 5074792, Nebraska 5073708 68046
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    Las Vegas, Nevada 89123
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    Las Vegas, Nevada 89106
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    Las Vegas 5506956, Nevada 5509151 89123
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    Schenectady 5136454, New York 5128638 12304
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    Asheville, North Carolina 28803
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    Morehead City, North Carolina 28557
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    Austin 4671654, Texas 4736286 78759
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    Site Not Available

  • Lexicon Investigational Site (221)

    San Antonio 4726206, Texas 4736286 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 (101)

    Salt Lake City 5780993, Utah 5549030 84102
    United States

    Site Not Available

  • Lexicon Investigational Site (219)

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • Lexicon Investigational Site (224)

    St. George 5546220, Utah 5549030 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

  • Lexicon Investigational Site (130)

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

  • Lexicon Investigational Site (165)

    Norfolk 4776222, Virginia 6254928 23510
    United States

    Site Not Available

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