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

NCT06203002 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: LX9211.1-204-DPNLX9211.204-DPN
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 108

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)

  ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].

  Baseline, Week 8

Secondary Outcomes (4)

• Change from Baseline to Week 8 in Burning Pain

  Baseline, Week 8

• Change from Baseline to Week 8 in Pain Interference on Sleep

  Baseline, Week 8

• Patient Global Impression of Change (PGIC) Score at Week 8

  Week 8

• Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score

  Baseline, Week 8

Study Arms (4)

LX9211 Low Dose

EXPERIMENTAL

LX9211 low dose, orally, once daily during a blinded treatment period.

Drug: LX9211 (blinded)

LX9211 High Dose

EXPERIMENTAL

LX9211 high dose, orally, once daily during a blinded treatment period.

Drug: LX9211 (blinded)

LX9211 High Dose Followed by Low Dose

EXPERIMENTAL

LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Drug: LX9211 (blinded)

LX9211 Placebo

PLACEBO COMPARATOR

LX9211 matching placebo, orally, once daily during a blinded treatment period.

Drug: Placebo (blinded)

Interventions

Placebo (blinded) DRUG

LX9211 matching placebo tablets

LX9211 Placebo

LX9211 (blinded) DRUG

LX9211 (blinded) tablets

LX9211 High Dose; LX9211 High Dose Followed by Low Dose; LX9211 Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has given written informed consent to participate in the study in accordance with local regulations
• Adult male and female participants ≥18 years of age at the Screening Visit
• Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening
• Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
• Pain from DPNP present for at least 6 months prior to Screening
• At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
• Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
• Willing to adhere to the prohibitions and restrictions specified in the protocol.

You may not qualify if:

• Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
• History of neurolytic or neurosurgical therapy for DPNP
• Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
• Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (108)

Lexicon Investigational Site (128)

Anniston, Alabama, 36207, United States

Location

Lexicon Investigational Site (222)

Birmingham, Alabama, 35216, United States

Location

Lexicon Investigational Site (189)

Daphne, Alabama, 36526, United States

Location

Lexicon Investigational Site (215)

Guntersville, Alabama, 35976, United States

Location

Lexicon Investigational Site (115)

Chandler, Arizona, 85286, United States

Location

Lexicon Investigational Site (195)

Phoenix, Arizona, 85028, United States

Location

Lexicon Investigational Site (206)

Scottsdale, Arizona, 85258, United States

Location

Lexicon Investigational Site (102)

Tucson, Arizona, 85741, United States

Location

Lexicon Investigational Site (107)

Anaheim, California, 92801, United States

Location

Lexicon Investigational Site (173)

Canoga Park, California, 91303, United States

Location

Lexicon Investigational Site (179)

Escondido, California, 92025, United States

Location

Lexicon Investigational Site (161)

Fresno, California, 93710, United States

Location

Lexicon Investigational Site (112)

Greenbrae, California, 94904, United States

Location

Lexicon Investigational Site (204)

Huntington Beach, California, 92647, United States

Location

Lexicon Investigational Site (191)

Inglewood, California, 90301, United States

Location

Lexicon Investigational Site (163)

Lomita, California, 90717, United States

Location

Lexicon Investigational Site (169)

Long Beach, California, 90806, United States

Location

Lexicon Investigational Site (111)

Sacramento, California, 95821, United States

Location

Lexicon Investigational Site (126)

Sacramento, California, 95821, United States

Location

Lexicon Investigational Site (129)

San Diego, California, 92103, United States

Location

Lexicon Investigational Site (154)

San Diego, California, 92120, United States

Location

Lexicon Investigational Site (124)

Tustin, California, 92780, United States

Location

Lexicon Investigational Site (211)

Vista, California, 92081, United States

Location

Lexicon Investigational Site (171)

Walnut Creek, California, 94596, United States

Location

Lexicon Investigational Site (181)

Walnut Creek, California, 94598, United States

Location

Lexicon Investigational Site (119)

Brandon, Florida, 33511, United States

Location

Lexicon Investigational Site (194)

Brandon, Florida, 33511, United States

Location

Lexicon Investigational Site (177)

Daytona Beach, Florida, 32117, United States

Location

Lexicon Investigational Site (198)

Fleming Island, Florida, 32003, United States

Location

Lexicon Investigational Site (109)

Fort Myers, Florida, 33912, United States

Location

Lexicon Investigational Site (180)

Hollywood, Florida, 33024, United States

Location

Lexicon Investigational Site (188)

Jacksonville, Florida, 32256, United States

Location

Lexicon Investigational Site (164)

Miami, Florida, 33176, United States

Location

Lexicon Investigational Site (105)

New Port Richey, Florida, 34652, United States

Location

Lexicon Investigational Site (146)

Orlando, Florida, 32801, United States

Location

Lexicon Investigational Site (144)

Orlando, Florida, 32806, United States

Location

Lexicon Investigational Site (123)

Ormond Beach, Florida, 32174, United States

Location

Lexicon Investigational Site (182)

Plantation, Florida, 33317, United States

Location

Lexicon Investigational Site (133)

The Villages, Florida, 32159, United States

Location

Lexicon Investigational Site (138)

The Villages, Florida, 32162, United States

Location

Lexicon Investigational Site (131)

Winter Haven, Florida, 33880, United States

Location

Lexicon Investigational Site (103)

Winter Park, Florida, 32789, United States

Location

Lexicon Investigational Site (150)

Atlanta, Georgia, 30303, United States

Location

Lexicon Investigational Site (151)

Marietta, Georgia, 30060, United States

Location

Lexicon Investigational Site (172)

Chicago, Illinois, 60623, United States

Location

Lexicon Investigational Site (132)

Flossmoor, Illinois, 60422, United States

Location

Lexicon Investigational Site (185)

El Dorado, Kansas, 67042, United States

Location

Lexicon Investigational Site (178)

Newton, Kansas, 67114, United States

Location

Lexicon Investigational Site (186)

Wichita, Kansas, 67207, United States

Location

Lexicon Investigational Site (213)

Owensboro, Kentucky, 42303, United States

Location

Lexicon Investigational Site (170)

New Orleans, Louisiana, 70115, United States

Location

Lexicon Investigational Site (190)

New Orleans, Louisiana, 70119, United States

Location

Lexicon Investigational Site (121)

Boston, Massachusetts, 02115, United States

Location

Lexicon Investigational Site (140)

New Bedford, Massachusetts, 02740, United States

Location

Lexicon Investigational Site (225)

Waltham, Massachusetts, 02451, United States

Location

Lexicon Investigational Site (125)

Ann Arbor, Michigan, 48109, United States

Location

Lexicon Investigational Site (108)

Dearborn, Michigan, 48126, United States

Location

Lexicon Investigational Site (139)

Olive Branch, Mississippi, 38654, United States

Location

Lexicon Investigational Site (104)

Hazelwood, Missouri, 63042, United States

Location

Lexicon Investigational Site (174)

Kansas City, Missouri, 64114, United States

Location

Lexicon Investigational Site (184)

Springfield, Missouri, 65807, United States

Location

Lexicon Investigational Site (156)

St Louis, Missouri, 63110, United States

Location

Lexicon Investigational Site (116)

Papillion, Nebraska, 68046, United States

Location

Lexicon Investigational Site (216)

Las Vegas, Nevada, 89106, United States

Location

Lexicon Investigational Site (162)

Las Vegas, Nevada, 89123, United States

Location

Lexicon Investigational Site (142)

New York, New York, 100029, United States

Location

Lexicon Investigational Site (227)

Rochester, New York, 14609, United States

Location

Lexicon Investigational Site (167)

Schenectady, New York, 12304, United States

Location

Lexicon Investigational Site (122)

Westfield, New York, 14787, United States

Location

Lexicon Investigational Site (110)

Williamsville, New York, 14221, United States

Location

Lexicon Investigational Site (200)

Asheville, North Carolina, 28803, United States

Location

Lexicon Investigational Site (209)

Greensboro, North Carolina, 27410, United States

Location

Lexicon Investigational Site (212)

Monroe, North Carolina, 28112, United States

Location

Lexicon Investigational Site (106)

Morehead City, North Carolina, 28557, United States

Location

Lexicon Investigational Site (145)

Winston-Salem, North Carolina, 27103, United States

Location

Lexicon Investigational Site (220)

Beavercreek, Ohio, 45432, United States

Location

Lexicon Investigational Site (168)

Dayton, Ohio, 45424, United States

Location

Lexicon Investigational Site (148)

Norman, Oklahoma, 73069, United States

Location

Lexicon Investigational Site (210)

Oklahoma City, Oklahoma, 73102, United States

Location

Lexicon Investigational Site (187)

Eugene, Oregon, 97404, United States

Location

Lexicon Investigational Site (183)

Charleston, South Carolina, 29406, United States

Location

Lexicon Investigational Site (201)

Columbia, South Carolina, 29205, United States

Location

Lexicon Investigational Site (113)

Greenville, South Carolina, 29607, United States

Location

Lexicon Investigational Site (205)

North Charleston, South Carolina, 29405, United States

Location

Lexicon Investigational Site (202)

Rock Hill, South Carolina, 29730, United States

Location

Lexicon Investigational Site (157)

Summerville, South Carolina, 29486, United States

Location

Lexicon Investigational Site (160)

Memphis, Tennessee, 38119, United States

Location

Lexicon Investigational Site (192)

Austin, Texas, 78759, United States

Location

Lexicon Investigational Site (199)

Baytown, Texas, 77521, United States

Location

Lexicon Investigational Site (193)

Dallas, Texas, 75230, United States

Location

Lexicon Investigational Site (158)

Dallas, Texas, 75231, United States

Location

Lexicon Investigational Site (153)

Euless, Texas, 76040, United States

Location

Lexicon Investigational Site (114)

Flower Mound, Texas, 75028, United States

Location

Lexicon Investigational Site (196)

Harlingen, Texas, 78550, United States

Location

Lexicon Investigational Site (120)

Houston, Texas, 77030, United States

Location

Lexicon Investigational Site (197)

Houston, Texas, 77065, United States

Location

Lexicon Investigational Site (152)

Houston, Texas, 77074, United States

Location

Lexicon Investigational Site (214)

Katy, Texas, 77494, United States

Location

Lexicon Investigational Site (155)

Lewisville, Texas, 75057, United States

Location

Lexicon Investigational Site (223)

Mesquite, Texas, 75150, United States

Location

Lexicon Investigational Site (203)

San Antonio, Texas, 78229, United States

Location

Lexicon Investigational Site (159)

San Antonio, Texas, 78233, United States

Location

Lexicon Investigational Site (221)

San Antonio, Texas, 78240, United States

Location

Lexicon Investigational Site (101)

Salt Lake City, Utah, 84102, United States

Location

Lexicon Investigational Site (219)

Salt Lake City, Utah, 84107, United States

Location

Lexicon Investigational Site (224)

St. George, Utah, 84790, United States

Location

Lexicon Investigational Site (130)

Manassas, Virginia, 20110, United States

Location

Lexicon Investigational Site (165)

Norfolk, Virginia, 23510, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 12, 2024
• Study Start: November 29, 2023
• Primary Completion: January 14, 2025
• Study Completion: February 24, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (108)