A Phase 2 interventional study of Placebo (blinded) and LX9211 (blinded) in Diabetic Peripheral Neuropathic Pain, sponsored by Lexicon Pharmaceuticals. Completed at 108 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Lexicon Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 291 studies in Neuralgia with a site in United States — 50 open to participants now, 61 under way, 5 of them phase 3. Neuralgia · United States.
Among the 291 studies in Neuralgia with a site in United States, this one is the 8th largest by enrollment of the 261 interventional ones that give a count, is one of 17 that started in 2023, is one of 78 in phase 2, and was the 248th registered.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
Browse Neuralgia studies →50 of the 291 studies in Neuralgia with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
James J. Peters Veterans Affairs Medical Center · Sites in United States
EicOsis Human Health Inc. · Sites in United States
Icahn School of Medicine at Mount Sinai · Sites in United States
Eli Lilly and Company · Sites in United States, Puerto Rico
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 152 Neuralgia studies recruiting now, 76 (50%) set no upper age limit and 44 (29%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
291 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 32 · Phase 2 94 · Phase 3 26 · Phase 4 14
First in 1993; this study’s year is marked. 17 started in 2023.
This study's enrollment of 496 is above the median of 52 across 831 interventional studies indexed under Neuralgia.
Median enrollment 40 across the 261 interventional studies, 53 across the 28 observational. Of the 193 that completed or were terminated, 86 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
105 of 291 have an industry lead sponsor. The 10 most frequent:
Lexicon Pharmaceuticals is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Lexicon Pharmaceuticals has 1 study filed under Neuralgia — fewer than ten, so there is no comparison to draw.
27 of the studies in Neuralgia with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06696443Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) | 2027-01-25 |
| NCT07231419Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy | 2027-04-06 |
| NCT06628908Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy | 2027-05-31 |
| NCT06848348Dogwood Therapeutics Inc.Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain | 2026-12 |
| NCT04865679Axogen CorporationTolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends | 2026-12 |
Among the 291 studies in Neuralgia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 high dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
Drug: LX9211 (blinded)
LX9211 matching placebo, orally, once daily during a blinded treatment period.
Drug: Placebo (blinded)
LX9211 matching placebo tablets
LX9211 (blinded) tablets
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].
Time frame: Baseline, Week 8
Change from Baseline to Week 8 in Burning Pain
Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]).
Time frame: 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 \[completely interferes\]).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8
Showing the first 100 of 108 sites. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Jan 2025, 13 months.
Of 34 industry-sponsored phase 2 interventional studies under Neuralgia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 13 months is close to that.
Counting every sponsor, half of 58 studies reached it within 22 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pilavapadin