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Diabetic Peripheral Neuropathic PainPhase 2PROGRESSNCT06203002

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

A Phase 2 study testing LX9211 (blinded) in people with Diabetic Peripheral Neuropathic Pain, run by Lexicon Pharmaceuticals at 108 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Peripheral Neuropathic Pain
What is being tested?
LX9211 (blinded)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
496 participants
Where
108 sitesUnited States
Study dates
29 Nov 2023to 24 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

United States108 sites

  • Lexicon Investigational Site (107)

    Anaheim, California, 92801

  • Lexicon Investigational Site (125)

    Ann Arbor, Michigan, 48109

  • Lexicon Investigational Site (128)

    Anniston, Alabama, 36207

  • Lexicon Investigational Site (200)

    Asheville, North Carolina, 28803

  • Lexicon Investigational Site (150)

    Atlanta, Georgia, 30303

  • Lexicon Investigational Site (192)

    Austin, Texas, 78759

  • Lexicon Investigational Site (199)

    Baytown, Texas, 77521

  • Lexicon Investigational Site (220)

    Beavercreek, Ohio, 45432

  • Lexicon Investigational Site (222)

    Birmingham, Alabama, 35216

  • Lexicon Investigational Site (121)

    Boston, Massachusetts, 02115

  • Lexicon Investigational Site (119)

    Brandon, Florida, 33511

  • Lexicon Investigational Site (194)

    Brandon, Florida, 33511

  • Lexicon Investigational Site (173)

    Canoga Park, California, 91303

  • Lexicon Investigational Site (115)

    Chandler, Arizona, 85286

  • Lexicon Investigational Site (183)

    Charleston, South Carolina, 29406

  • Lexicon Investigational Site (172)

    Chicago, Illinois, 60623

  • Lexicon Investigational Site (201)

    Columbia, South Carolina, 29205

  • Lexicon Investigational Site (193)

    Dallas, Texas, 75230

  • Lexicon Investigational Site (158)

    Dallas, Texas, 75231

  • Lexicon Investigational Site (189)

    Daphne, Alabama, 36526

  • Lexicon Investigational Site (168)

    Dayton, Ohio, 45424

  • Lexicon Investigational Site (177)

    Daytona Beach, Florida, 32117

  • Lexicon Investigational Site (108)

    Dearborn, Michigan, 48126

  • Lexicon Investigational Site (185)

    El Dorado, Kansas, 67042

  • Lexicon Investigational Site (179)

    Escondido, California, 92025

  • Lexicon Investigational Site (187)

    Eugene, Oregon, 97404

  • Lexicon Investigational Site (153)

    Euless, Texas, 76040

  • Lexicon Investigational Site (198)

    Fleming Island, Florida, 32003

  • Lexicon Investigational Site (132)

    Flossmoor, Illinois, 60422

  • Lexicon Investigational Site (114)

    Flower Mound, Texas, 75028

  • Lexicon Investigational Site (109)

    Fort Myers, Florida, 33912

  • Lexicon Investigational Site (161)

    Fresno, California, 93710

  • Lexicon Investigational Site (112)

    Greenbrae, California, 94904

  • Lexicon Investigational Site (209)

    Greensboro, North Carolina, 27410

  • Lexicon Investigational Site (113)

    Greenville, South Carolina, 29607

  • Lexicon Investigational Site (215)

    Guntersville, Alabama, 35976

  • Lexicon Investigational Site (196)

    Harlingen, Texas, 78550

  • Lexicon Investigational Site (104)

    Hazelwood, Missouri, 63042

  • Lexicon Investigational Site (180)

    Hollywood, Florida, 33024

  • Lexicon Investigational Site (120)

    Houston, Texas, 77030

  • Lexicon Investigational Site (197)

    Houston, Texas, 77065

  • Lexicon Investigational Site (152)

    Houston, Texas, 77074

  • Lexicon Investigational Site (204)

    Huntington Beach, California, 92647

  • Lexicon Investigational Site (191)

    Inglewood, California, 90301

  • Lexicon Investigational Site (188)

    Jacksonville, Florida, 32256

  • Lexicon Investigational Site (174)

    Kansas City, Missouri, 64114

  • Lexicon Investigational Site (214)

    Katy, Texas, 77494

  • Lexicon Investigational Site (216)

    Las Vegas, Nevada, 89106

  • Lexicon Investigational Site (162)

    Las Vegas, Nevada, 89123

  • Lexicon Investigational Site (155)

    Lewisville, Texas, 75057

  • Lexicon Investigational Site (163)

    Lomita, California, 90717

  • Lexicon Investigational Site (169)

    Long Beach, California, 90806

  • Lexicon Investigational Site (130)

    Manassas, Virginia, 20110

  • Lexicon Investigational Site (151)

    Marietta, Georgia, 30060

  • Lexicon Investigational Site (160)

    Memphis, Tennessee, 38119

  • Lexicon Investigational Site (223)

    Mesquite, Texas, 75150

  • Lexicon Investigational Site (164)

    Miami, Florida, 33176

  • Lexicon Investigational Site (212)

    Monroe, North Carolina, 28112

  • Lexicon Investigational Site (106)

    Morehead City, North Carolina, 28557

  • Lexicon Investigational Site (140)

    New Bedford, Massachusetts, 02740

  • Lexicon Investigational Site (170)

    New Orleans, Louisiana, 70115

  • Lexicon Investigational Site (190)

    New Orleans, Louisiana, 70119

  • Lexicon Investigational Site (105)

    New Port Richey, Florida, 34652

  • Lexicon Investigational Site (142)

    New York, New York, 100029

  • Lexicon Investigational Site (178)

    Newton, Kansas, 67114

  • Lexicon Investigational Site (165)

    Norfolk, Virginia, 23510

  • Lexicon Investigational Site (148)

    Norman, Oklahoma, 73069

  • Lexicon Investigational Site (205)

    North Charleston, South Carolina, 29405

  • Lexicon Investigational Site (210)

    Oklahoma City, Oklahoma, 73102

  • Lexicon Investigational Site (139)

    Olive Branch, Mississippi, 38654

  • Lexicon Investigational Site (146)

    Orlando, Florida, 32801

  • Lexicon Investigational Site (144)

    Orlando, Florida, 32806

  • Lexicon Investigational Site (123)

    Ormond Beach, Florida, 32174

  • Lexicon Investigational Site (213)

    Owensboro, Kentucky, 42303

  • Lexicon Investigational Site (116)

    Papillion, Nebraska, 68046

  • Lexicon Investigational Site (195)

    Phoenix, Arizona, 85028

  • Lexicon Investigational Site (182)

    Plantation, Florida, 33317

  • Lexicon Investigational Site (227)

    Rochester, New York, 14609

  • Lexicon Investigational Site (202)

    Rock Hill, South Carolina, 29730

  • Lexicon Investigational Site (111)

    Sacramento, California, 95821

  • Lexicon Investigational Site (126)

    Sacramento, California, 95821

  • Lexicon Investigational Site (101)

    Salt Lake City, Utah, 84102

  • Lexicon Investigational Site (219)

    Salt Lake City, Utah, 84107

  • Lexicon Investigational Site (203)

    San Antonio, Texas, 78229

  • Lexicon Investigational Site (159)

    San Antonio, Texas, 78233

  • Lexicon Investigational Site (221)

    San Antonio, Texas, 78240

  • Lexicon Investigational Site (129)

    San Diego, California, 92103

  • Lexicon Investigational Site (154)

    San Diego, California, 92120

  • Lexicon Investigational Site (167)

    Schenectady, New York, 12304

  • Lexicon Investigational Site (206)

    Scottsdale, Arizona, 85258

  • Lexicon Investigational Site (184)

    Springfield, Missouri, 65807

  • Lexicon Investigational Site (156)

    St Louis, Missouri, 63110

  • Lexicon Investigational Site (224)

    St. George, Utah, 84790

  • Lexicon Investigational Site (157)

    Summerville, South Carolina, 29486

  • Lexicon Investigational Site (133)

    The Villages, Florida, 32159

  • Lexicon Investigational Site (138)

    The Villages, Florida, 32162

  • Lexicon Investigational Site (102)

    Tucson, Arizona, 85741

  • Lexicon Investigational Site (124)

    Tustin, California, 92780

  • Lexicon Investigational Site (211)

    Vista, California, 92081

  • Lexicon Investigational Site (171)

    Walnut Creek, California, 94596

  • Lexicon Investigational Site (181)

    Walnut Creek, California, 94598

  • Lexicon Investigational Site (225)

    Waltham, Massachusetts, 02451

  • Lexicon Investigational Site (122)

    Westfield, New York, 14787

  • Lexicon Investigational Site (186)

    Wichita, Kansas, 67207

  • Lexicon Investigational Site (110)

    Williamsville, New York, 14221

  • Lexicon Investigational Site (145)

    Winston-Salem, North Carolina, 27103

  • Lexicon Investigational Site (131)

    Winter Haven, Florida, 33880

  • Lexicon Investigational Site (103)

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: 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/

Being tested
Placebo (blinded), LX9211 (blinded)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo (blinded)Drug

    LX9211 matching placebo tablets

  • LX9211 (blinded)Drug

    LX9211 (blinded) tablets

Study groups in NCT06203002
Study groupRoleWhat they receive
LX9211 Low DoseExperimentalLX9211 low dose, orally, once daily during a blinded treatment period.
Receives: Drug: LX9211 (blinded)
LX9211 High DoseExperimentalLX9211 high dose, orally, once daily during a blinded treatment period.
Receives: Drug: LX9211 (blinded)
LX9211 High Dose Followed by Low DoseExperimentalLX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
Receives: Drug: LX9211 (blinded)
LX9211 PlaceboPlacebo comparatorLX9211 matching placebo, orally, once daily during a blinded treatment period.
Receives: Drug: Placebo (blinded)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)].

    Measured: Baseline, Week 8

Secondary outcomes (4)

  1. 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]).

    Measured: Baseline, Week 8

  2. 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]).

    Measured: Baseline, Week 8

  3. 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.

    Measured: Week 8

  4. 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.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start29 Nov 2023
  3. Primary completion14 Jan 2025
  4. Study completion24 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
496 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06203002
Sponsor's protocol ID
LX9211.1-204-DPN
Other IDs
LX9211.204-DPN
Acronym
PROGRESS
Status last verified
Oct 2025
First submitted
30 Nov 2023
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LX9211 (blinded) in people with Diabetic Peripheral Neuropathic Pain, run by Lexicon Pharmaceuticals at 108 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 8 in Average Daily Pain Score (ADPS) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06203002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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