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New drug LX9211 aims to ease diabetic nerve pain

NCT ID NCT06203002

Symptom relief Sponsor: Lexicon Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called LX9211 in 496 adults with diabetic peripheral neuropathic pain (nerve pain from diabetes). The goal was to see if it reduces average daily pain and improves sleep compared to a placebo over 8 weeks. The trial is complete, and results will show if LX9211 is a promising option for this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LX9211
What this could lead to
If it works, this could point toward a new pain reliever for people with diabetic nerve pain.
What could go wrong
This is an early phase 2 trial, so results may not confirm effectiveness. The drug might not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

496 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathic pain

Contacts and locations

Locations

  • Lexicon Investigational Site (101)

    Salt Lake City, Utah, 84102, United States

  • Lexicon Investigational Site (102)

    Tucson, Arizona, 85741, United States

  • Lexicon Investigational Site (103)

    Winter Park, Florida, 32789, United States

  • Lexicon Investigational Site (104)

    Hazelwood, Missouri, 63042, United States

  • Lexicon Investigational Site (105)

    New Port Richey, Florida, 34652, United States

  • Lexicon Investigational Site (106)

    Morehead City, North Carolina, 28557, United States

  • Lexicon Investigational Site (107)

    Anaheim, California, 92801, United States

  • Lexicon Investigational Site (108)

    Dearborn, Michigan, 48126, United States

  • Lexicon Investigational Site (109)

    Fort Myers, Florida, 33912, United States

  • Lexicon Investigational Site (110)

    Williamsville, New York, 14221, United States

  • Lexicon Investigational Site (111)

    Sacramento, California, 95821, United States

  • Lexicon Investigational Site (112)

    Greenbrae, California, 94904, United States

  • Lexicon Investigational Site (113)

    Greenville, South Carolina, 29607, United States

  • Lexicon Investigational Site (114)

    Flower Mound, Texas, 75028, United States

  • Lexicon Investigational Site (115)

    Chandler, Arizona, 85286, United States

  • Lexicon Investigational Site (116)

    Papillion, Nebraska, 68046, United States

  • Lexicon Investigational Site (119)

    Brandon, Florida, 33511, United States

  • Lexicon Investigational Site (120)

    Houston, Texas, 77030, United States

  • Lexicon Investigational Site (121)

    Boston, Massachusetts, 02115, United States

  • Lexicon Investigational Site (122)

    Westfield, New York, 14787, United States

  • Lexicon Investigational Site (123)

    Ormond Beach, Florida, 32174, United States

  • Lexicon Investigational Site (124)

    Tustin, California, 92780, United States

  • Lexicon Investigational Site (125)

    Ann Arbor, Michigan, 48109, United States

  • Lexicon Investigational Site (126)

    Sacramento, California, 95821, United States

  • Lexicon Investigational Site (128)

    Anniston, Alabama, 36207, United States

  • Lexicon Investigational Site (129)

    San Diego, California, 92103, United States

  • Lexicon Investigational Site (130)

    Manassas, Virginia, 20110, United States

  • Lexicon Investigational Site (131)

    Winter Haven, Florida, 33880, United States

  • Lexicon Investigational Site (132)

    Flossmoor, Illinois, 60422, United States

  • Lexicon Investigational Site (133)

    The Villages, Florida, 32159, United States

  • Lexicon Investigational Site (138)

    The Villages, Florida, 32162, United States

  • Lexicon Investigational Site (139)

    Olive Branch, Mississippi, 38654, United States

  • Lexicon Investigational Site (140)

    New Bedford, Massachusetts, 02740, United States

  • Lexicon Investigational Site (142)

    New York, New York, 100029, United States

  • Lexicon Investigational Site (144)

    Orlando, Florida, 32806, United States

  • Lexicon Investigational Site (145)

    Winston-Salem, North Carolina, 27103, United States

  • Lexicon Investigational Site (146)

    Orlando, Florida, 32801, United States

  • Lexicon Investigational Site (148)

    Norman, Oklahoma, 73069, United States

  • Lexicon Investigational Site (150)

    Atlanta, Georgia, 30303, United States

  • Lexicon Investigational Site (151)

    Marietta, Georgia, 30060, United States

  • Lexicon Investigational Site (152)

    Houston, Texas, 77074, United States

  • Lexicon Investigational Site (153)

    Euless, Texas, 76040, United States

  • Lexicon Investigational Site (154)

    San Diego, California, 92120, United States

  • Lexicon Investigational Site (155)

    Lewisville, Texas, 75057, United States

  • Lexicon Investigational Site (156)

    St Louis, Missouri, 63110, United States

  • Lexicon Investigational Site (157)

    Summerville, South Carolina, 29486, United States

  • Lexicon Investigational Site (158)

    Dallas, Texas, 75231, United States

  • Lexicon Investigational Site (159)

    San Antonio, Texas, 78233, United States

  • Lexicon Investigational Site (160)

    Memphis, Tennessee, 38119, United States

  • Lexicon Investigational Site (161)

    Fresno, California, 93710, United States

  • Lexicon Investigational Site (162)

    Las Vegas, Nevada, 89123, United States

  • Lexicon Investigational Site (163)

    Lomita, California, 90717, United States

  • Lexicon Investigational Site (164)

    Miami, Florida, 33176, United States

  • Lexicon Investigational Site (165)

    Norfolk, Virginia, 23510, United States

  • Lexicon Investigational Site (167)

    Schenectady, New York, 12304, United States

  • Lexicon Investigational Site (168)

    Dayton, Ohio, 45424, United States

  • Lexicon Investigational Site (169)

    Long Beach, California, 90806, United States

  • Lexicon Investigational Site (170)

    New Orleans, Louisiana, 70115, United States

  • Lexicon Investigational Site (171)

    Walnut Creek, California, 94596, United States

  • Lexicon Investigational Site (172)

    Chicago, Illinois, 60623, United States

  • Lexicon Investigational Site (173)

    Canoga Park, California, 91303, United States

  • Lexicon Investigational Site (174)

    Kansas City, Missouri, 64114, United States

  • Lexicon Investigational Site (177)

    Daytona Beach, Florida, 32117, United States

  • Lexicon Investigational Site (178)

    Newton, Kansas, 67114, United States

  • Lexicon Investigational Site (179)

    Escondido, California, 92025, United States

  • Lexicon Investigational Site (180)

    Hollywood, Florida, 33024, United States

  • Lexicon Investigational Site (181)

    Walnut Creek, California, 94598, United States

  • Lexicon Investigational Site (182)

    Plantation, Florida, 33317, United States

  • Lexicon Investigational Site (183)

    Charleston, South Carolina, 29406, United States

  • Lexicon Investigational Site (184)

    Springfield, Missouri, 65807, United States

  • Lexicon Investigational Site (185)

    El Dorado, Kansas, 67042, United States

  • Lexicon Investigational Site (186)

    Wichita, Kansas, 67207, United States

  • Lexicon Investigational Site (187)

    Eugene, Oregon, 97404, United States

  • Lexicon Investigational Site (188)

    Jacksonville, Florida, 32256, United States

  • Lexicon Investigational Site (189)

    Daphne, Alabama, 36526, United States

  • Lexicon Investigational Site (190)

    New Orleans, Louisiana, 70119, United States

  • Lexicon Investigational Site (191)

    Inglewood, California, 90301, United States

  • Lexicon Investigational Site (192)

    Austin, Texas, 78759, United States

  • Lexicon Investigational Site (193)

    Dallas, Texas, 75230, United States

  • Lexicon Investigational Site (194)

    Brandon, Florida, 33511, United States

  • Lexicon Investigational Site (195)

    Phoenix, Arizona, 85028, United States

  • Lexicon Investigational Site (196)

    Harlingen, Texas, 78550, United States

  • Lexicon Investigational Site (197)

    Houston, Texas, 77065, United States

  • Lexicon Investigational Site (198)

    Fleming Island, Florida, 32003, United States

  • Lexicon Investigational Site (199)

    Baytown, Texas, 77521, United States

  • Lexicon Investigational Site (200)

    Asheville, North Carolina, 28803, United States

  • Lexicon Investigational Site (201)

    Columbia, South Carolina, 29205, United States

  • Lexicon Investigational Site (202)

    Rock Hill, South Carolina, 29730, United States

  • Lexicon Investigational Site (203)

    San Antonio, Texas, 78229, United States

  • Lexicon Investigational Site (204)

    Huntington Beach, California, 92647, United States

  • Lexicon Investigational Site (205)

    North Charleston, South Carolina, 29405, United States

  • Lexicon Investigational Site (206)

    Scottsdale, Arizona, 85258, United States

  • Lexicon Investigational Site (209)

    Greensboro, North Carolina, 27410, United States

  • Lexicon Investigational Site (210)

    Oklahoma City, Oklahoma, 73102, United States

  • Lexicon Investigational Site (211)

    Vista, California, 92081, United States

  • Lexicon Investigational Site (212)

    Monroe, North Carolina, 28112, United States

  • Lexicon Investigational Site (213)

    Owensboro, Kentucky, 42303, United States

  • Lexicon Investigational Site (214)

    Katy, Texas, 77494, United States

  • Lexicon Investigational Site (215)

    Guntersville, Alabama, 35976, United States

  • Lexicon Investigational Site (216)

    Las Vegas, Nevada, 89106, United States

  • Lexicon Investigational Site (219)

    Salt Lake City, Utah, 84107, United States

  • Lexicon Investigational Site (220)

    Beavercreek, Ohio, 45432, United States

  • Lexicon Investigational Site (221)

    San Antonio, Texas, 78240, United States

  • Lexicon Investigational Site (222)

    Birmingham, Alabama, 35216, United States

  • Lexicon Investigational Site (223)

    Mesquite, Texas, 75150, United States

  • Lexicon Investigational Site (224)

    St. George, Utah, 84790, United States

  • Lexicon Investigational Site (225)

    Waltham, Massachusetts, 02451, United States

  • Lexicon Investigational Site (227)

    Rochester, New York, 14609, United States

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Other studies related to the condition(s) this trial covers.