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

A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)

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

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: LX9211 (blinded); Drug: Placebo (blinded)

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Lexicon Investigational Site (128)
    • Birmingham, Alabama, United States, 35216
      • Lexicon Investigational Site (222)
    • Daphne, Alabama, United States, 36526
      • Lexicon Investigational Site (189)
    • Guntersville, Alabama, United States, 35976
      • Lexicon Investigational Site (215)
  • Arizona
    • Chandler, Arizona, United States, 85286
      • Lexicon Investigational Site (115)
    • Phoenix, Arizona, United States, 85028
      • Lexicon Investigational Site (195)
    • Scottsdale, Arizona, United States, 85258
      • Lexicon Investigational Site (206)
    • Tucson, Arizona, United States, 85741
      • Lexicon Investigational Site (102)
  • California
    • Anaheim, California, United States, 92801
      • Lexicon Investigational Site (107)
    • Canoga Park, California, United States, 91303
      • Lexicon Investigational Site (173)
    • Escondido, California, United States, 92025
      • Lexicon Investigational Site (179)
    • Fresno, California, United States, 93710
      • Lexicon Investigational Site (161)
    • Greenbrae, California, United States, 94904
      • Lexicon Investigational Site (112)
    • Huntington Beach, California, United States, 92647
      • Lexicon Investigational Site (204)
    • Inglewood, California, United States, 90301
      • Lexicon Investigational Site (191)
    • Lomita, California, United States, 90717
      • Lexicon Investigational Site (163)
    • Long Beach, California, United States, 90806
      • Lexicon Investigational Site (169)
    • Sacramento, California, United States, 95821
      • Lexicon Investigational Site (111)
    • Sacramento, California, United States, 95821
      • Lexicon Investigational Site (126)
    • San Diego, California, United States, 92103
      • Lexicon Investigational Site (129)
    • San Diego, California, United States, 92120
      • Lexicon Investigational Site (154)
    • Tustin, California, United States, 92780
      • Lexicon Investigational Site (124)
    • Vista, California, United States, 92081
      • Lexicon Investigational Site (211)
    • Walnut Creek, California, United States, 94598
      • Lexicon Investigational Site (181)
    • Walnut Creek, California, United States, 94596
      • Lexicon Investigational Site (171)
  • Florida
    • Brandon, Florida, United States, 33511
      • Lexicon Investigational Site (119)
    • Brandon, Florida, United States, 33511
      • Lexicon Investigational Site (194)
    • Daytona Beach, Florida, United States, 32117
      • Lexicon Investigational Site (177)
    • Fleming Island, Florida, United States, 32003
      • Lexicon Investigational Site (198)
    • Fort Myers, Florida, United States, 33912
      • Lexicon Investigational Site (109)
    • Hollywood, Florida, United States, 33024
      • Lexicon Investigational Site (180)
    • Jacksonville, Florida, United States, 32256
      • Lexicon Investigational Site (188)
    • Miami, Florida, United States, 33176
      • Lexicon Investigational Site (164)
    • New Port Richey, Florida, United States, 34652
      • Lexicon Investigational Site (105)
    • Orlando, Florida, United States, 32801
      • Lexicon Investigational Site (146)
    • Orlando, Florida, United States, 32806
      • Lexicon Investigational Site (144)
    • Ormond Beach, Florida, United States, 32174
      • Lexicon Investigational Site (123)
    • Plantation, Florida, United States, 33317
      • Lexicon Investigational Site (182)
    • The Villages, Florida, United States, 32159
      • Lexicon Investigational Site (133)
    • The Villages, Florida, United States, 32162
      • Lexicon Investigational Site (138)
    • Winter Haven, Florida, United States, 33880
      • Lexicon Investigational Site (131)
    • Winter Park, Florida, United States, 32789
      • Lexicon Investigational Site (103)
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Lexicon Investigational Site (150)
    • Marietta, Georgia, United States, 30060
      • Lexicon Investigational Site (151)
  • Illinois
    • Chicago, Illinois, United States, 60623
      • Lexicon Investigational Site (172)
    • Flossmoor, Illinois, United States, 60422
      • Lexicon Investigational Site (132)
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Lexicon Investigational Site (185)
    • Newton, Kansas, United States, 67114
      • Lexicon Investigational Site (178)
    • Wichita, Kansas, United States, 67207
      • Lexicon Investigational Site (186)
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Lexicon Investigational Site (213)
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Lexicon Investigational Site (170)
    • New Orleans, Louisiana, United States, 70119
      • Lexicon Investigational Site (190)
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Lexicon Investigational Site (121)
    • New Bedford, Massachusetts, United States, 02740
      • Lexicon Investigational Site (140)
    • Waltham, Massachusetts, United States, 02451
      • Lexicon Investigational Site (225)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Lexicon Investigational Site (125)
    • Dearborn, Michigan, United States, 48126
      • Lexicon Investigational Site (108)
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Lexicon Investigational Site (139)
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Lexicon Investigational Site (104)
    • Kansas City, Missouri, United States, 64114
      • Lexicon Investigational Site (174)
    • Springfield, Missouri, United States, 65807
      • Lexicon Investigational Site (184)
    • St Louis, Missouri, United States, 63110
      • Lexicon Investigational Site (156)
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • Lexicon Investigational Site (116)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Lexicon Investigational Site (216)
    • Las Vegas, Nevada, United States, 89123
      • Lexicon Investigational Site (162)
  • New York
    • New York, New York, United States, 100029
      • Lexicon Investigational Site (142)
    • Rochester, New York, United States, 14609
      • Lexicon Investigational Site (227)
    • Schenectady, New York, United States, 12304
      • Lexicon Investigational Site (167)
    • Westfield, New York, United States, 14787
      • Lexicon Investigational Site (122)
    • Williamsville, New York, United States, 14221
      • Lexicon Investigational Site (110)
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Lexicon Investigational Site (200)
    • Greensboro, North Carolina, United States, 27410
      • Lexicon Investigational Site (209)
    • Monroe, North Carolina, United States, 28112
      • Lexicon Investigational Site (212)
    • Morehead City, North Carolina, United States, 28557
      • Lexicon Investigational Site (106)
    • Winston-Salem, North Carolina, United States, 27103
      • Lexicon Investigational Site (145)
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Lexicon Investigational Site (220)
    • Dayton, Ohio, United States, 45424
      • Lexicon Investigational Site (168)
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lexicon Investigational Site (148)
    • Oklahoma City, Oklahoma, United States, 73102
      • Lexicon Investigational Site (210)
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Lexicon Investigational Site (187)
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lexicon Investigational Site (183)
    • Columbia, South Carolina, United States, 29205
      • Lexicon Investigational Site (201)
    • Greenville, South Carolina, United States, 29607
      • Lexicon Investigational Site (113)
    • North Charleston, South Carolina, United States, 29405
      • Lexicon Investigational Site (205)
    • Rock Hill, South Carolina, United States, 29730
      • Lexicon Investigational Site (202)
    • Summerville, South Carolina, United States, 29486
      • Lexicon Investigational Site (157)
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Lexicon Investigational Site (160)
  • Texas
    • Austin, Texas, United States, 78759
      • Lexicon Investigational Site (192)
    • Baytown, Texas, United States, 77521
      • Lexicon Investigational Site (199)
    • Dallas, Texas, United States, 75230
      • Lexicon Investigational Site (193)
    • Dallas, Texas, United States, 75231
      • Lexicon Investigational Site (158)
    • Euless, Texas, United States, 76040
      • Lexicon Investigational Site (153)
    • Flower Mound, Texas, United States, 75028
      • Lexicon Investigational Site (114)
    • Harlingen, Texas, United States, 78550
      • Lexicon Investigational Site (196)
    • Houston, Texas, United States, 77030
      • Lexicon Investigational Site (120)
    • Houston, Texas, United States, 77065
      • Lexicon Investigational Site (197)
    • Houston, Texas, United States, 77074
      • Lexicon Investigational Site (152)
    • Katy, Texas, United States, 77494
      • Lexicon Investigational Site (214)
    • Lewisville, Texas, United States, 75057
      • Lexicon Investigational Site (155)
    • Mesquite, Texas, United States, 75150
      • Lexicon Investigational Site (223)
    • San Antonio, Texas, United States, 78229
      • Lexicon Investigational Site (203)
    • San Antonio, Texas, United States, 78233
      • Lexicon Investigational Site (159)
    • San Antonio, Texas, United States, 78240
      • Lexicon Investigational Site (221)
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Lexicon Investigational Site (101)
    • Salt Lake City, Utah, United States, 84107
      • Lexicon Investigational Site (219)
    • St. George, Utah, United States, 84790
      • Lexicon Investigational Site (224)
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Lexicon Investigational Site (130)
    • Norfolk, Virginia, United States, 23510
      • Lexicon Investigational Site (165)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant has given written informed consent to participate in the study in accordance 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) 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:

1. Presence of other painful conditions that may confound assessment or self-evaluation of 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LX9211 Low Dose; LX9211 low dose, orally, once daily during a blinded treatment period.	Drug: LX9211 (blinded); LX9211 (blinded) tablets
Experimental: LX9211 High Dose; LX9211 high dose, orally, once daily during a blinded treatment period.	Drug: LX9211 (blinded); LX9211 (blinded) tablets
Experimental: LX9211 High Dose Followed by Low Dose; LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.	Drug: LX9211 (blinded); LX9211 (blinded) tablets
Placebo Comparator: LX9211 Placebo; LX9211 matching placebo, orally, once daily during a blinded treatment period.	Drug: Placebo (blinded); LX9211 matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 8 in Burning Pain	Burning pain is based on the 11-point NRS (0 [no burning] to 10 [worst burning imaginable]).	Baseline, Week 8
Change from Baseline to Week 8 in Pain Interference on Sleep	Pain interference on sleep is based on the 11-point NRS (0 [does not interfere] to 10 [completely interferes]).	Baseline, Week 8
Patient Global Impression of Change (PGIC) Score at Week 8	The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.	Week 8
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score	NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Actual): January 14, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Neuralgia; Diabetic Neuropathies; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: LX9211.1-204-DPN; LX9211.204-DPN (Other Identifier: Lexicon Pharmaceuticals, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No