A Phase 2 interventional study of LX9211 and LX9211 Matching Placebo in Diabetic Peripheral Neuropathy and Diabetes, sponsored by Lexicon Pharmaceuticals. Completed at 44 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Lexicon Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 3,021 studies in Diabetes Mellitus with a site in United States — 288 open to participants now, 389 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,021 studies in Diabetes Mellitus with a site in United States, this one is the 537th largest by enrollment of the 2,500 interventional ones that give a count, is one of 95 that started in 2020, is one of 279 in phase 2, and was the 2,412th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →288 of the 3,021 studies in Diabetes Mellitus with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
University of California, Los Angeles · Sites in United States
Mayo Clinic · Sites in United States
Pfizer · Sites in United States
University of Colorado, Denver · Sites in United States
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 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 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.
3,021 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 1 262 · Phase 2 371 · Phase 3 340 · Phase 4 215
First in 1976; this study’s year is marked. 95 started in 2020.
This study's enrollment of 319 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Median enrollment 82 across the 2,500 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 987 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
852 of 3,021 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 2 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Among the 3,021 studies in Diabetes Mellitus 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 a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
Drug: LX9211 Matching Placebo
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
Drug: LX9211
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
Drug: LX9211
Oral Tablets
Oral Tablets
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \>(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \>(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
BPI-DPN: questionnaire that assesses severity of pain \& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy
Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Patient Global Impression of Change (PGIC) Scale Score at Week 6
PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.
Time frame: Baseline (Week 2 of the Run-in period) to Week 6
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6
For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Time frame: Weeks 6 to 11
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.
Time frame: First dose of study drug after randomization up to the end of study (up to Week 11)
Participants took part in the study at multiple investigative sites in the United States from 03 Sep 2020 to 28 Jun 2022.
| Milestone | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Started | 107 | 106 | 106 |
| Completed | 101 | 85 | 70 |
| Not completed | 6 | 21 | 36 |
| Withdrew: Adverse event | 4 | 17 | 28 |
| Withdrew: Subject choice unrelated to adverse event/serious adverse event | 2 | 2 | 6 |
| Withdrew: Other, not specified | 0 | 2 | 2 |
| Milestone | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Started | 104 | 99 | 92 |
| Completed | 103 | 99 | 92 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Other, not specified | 1 | 0 | 0 |
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
| score on a scale | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale | -0.72 (-1.08 to -0.36) | -1.39 (-1.77 to -1.01) | -1.27 (-1.66 to -0.88) |
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \>(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
| percentage of participants | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6 | 17.8 | 27.4 | 17.0 |
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \>(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
| percentage of participants | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 | 10.3 | 15.1 | 9.4 |
BPI-DPN: questionnaire that assesses severity of pain \& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.
| score on a scale | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Pain at its Worst | -0.69 (-1.11 to -0.26) | -1.42 (-1.87 to -0.97) | -1.38 (-1.81 to -0.96) |
| Pain at its Least | -0.69 (-1.13 to -0.26) | -1.43 (-1.89 to -0.98) | -1.38 (-1.81 to -0.95) |
| Pain Right Now | -0.55 (-1.00 to -0.10) | -1.42 (-1.89 to -0.95) | -1.03 (-1.47 to -0.59) |
| Interference Score Averaged Over Questions 9A - G | -0.74 (-1.17 to -0.30) | -1.00 (-1.46 to -0.53) | -0.97 (-1.41 to -0.53) |
| General Activity | -0.77 (-1.25 to -0.28) | -0.96 (-1.48 to -0.44) | -0.82 (-1.31 to -0.33) |
| Mood | -0.71 (-1.22 to -0.19) | -0.72 (-1.27 to -0.16) | -0.65 (-1.18 to -0.13) |
| Walking Ability | -0.74 (-1.24 to -0.24) | -1.36 (-1.89 to -0.83) | -1.22 (-1.73 to -0.72) |
| Normal Work | -1.01 (-1.50 to -0.53) | -1.07 (-1.58 to -0.55) | -1.05 (-1.54 to -0.56) |
| Relations with Other People | -0.29 (-0.79 to 0.20) | 0.14 (-0.39 to 0.67) | -0.09 (-0.59 to 0.41) |
| Sleep | -0.48 (-0.96 to -0.01) | -1.45 (-1.96 to -0.94) | -1.52 (-2.00 to -1.04) |
| Enjoyment of Life | -1.03 (-1.53 to -0.52) | -1.05 (-1.59 to -0.50) | -1.13 (-1.64 to -0.61) |
Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.
| percentage of participants | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy | 0 | 0 | 0 |
PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.
| score on a scale | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Patient Global Impression of Change (PGIC) Scale Score at Week 6 | 3.28 (3.04 to 3.52) | 2.93 (2.69 to 3.17) | 3.13 (2.88 to 3.38) |
For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
| weeks | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg |
|---|---|---|---|
| Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6 | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.
| Participants | Placebo (Double-blind Treatment Period) | LX9211 100 mg/10 mg (Double-blind Treatment Period) | LX9211 200 mg/20 mg (Double-blind Treatment Period) | Placebo (Single-blind Follow-up Period) | LX9211 100 mg/10 mg (Single-blind Follow-up Period) | LX9211 200 mg/20 mg Single-blind Follow-up Period) |
|---|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 32 | 57 | 54 | 15 | 21 | 18 |
Collected over First dose of study drug after randomization up to the end of study (up to Week 11). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (Double-blind Treatment Period) | 1/107 (0.9%) | 1/107 (0.9%) | 9/107 (8.4%) |
| LX9211 100 mg/10 mg (Double-blind Treatment Period) | 0/106 (0%) | 0/106 (0%) | 39/106 (36.8%) |
| LX9211 200 mg/20 mg (Double-blind Treatment Period) | 1/106 (0.9%) | 2/106 (1.9%) | 44/106 (41.5%) |
| Placebo (Single-blind Follow-up Period) | 0/104 (0%) | 1/104 (1%) | 4/104 (3.8%) |
| LX9211 100 mg/10 mg (Single-blind Follow-up Period) | 0/99 (0%) | 1/99 (1%) | 2/99 (2%) |
| LX9211 200 mg/20 mg Single-blind Follow-up Period) | 0/92 (0%) | 1/92 (1.1%) | 6/92 (6.5%) |
| Event | Placebo (Double-blind Treatment Period) | LX9211 100 mg/10 mg (Double-blind Treatment Period) | LX9211 200 mg/20 mg (Double-blind Treatment Period) | Placebo (Single-blind Follow-up Period) | LX9211 100 mg/10 mg (Single-blind Follow-up Period) | LX9211 200 mg/20 mg Single-blind Follow-up Period) |
|---|---|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/107 | 0/106 | 0/106 | 0/104 | 0/99 | 1/92 |
| Supraventricular tachycardiaCardiac disorders | 0/107 | 0/106 | 0/106 | 0/104 | 0/99 | 1/92 |
| Coronavirus infectionInfections and infestations | 0/107 | 0/106 | 0/106 | 0/104 | 1/99 | 0/92 |
| Abdominal pain lowerGastrointestinal disorders | 0/107 | 0/106 | 0/106 | 1/104 | 0/99 | 0/92 |
| Oedema peripheralGeneral disorders | 0/107 | 0/106 | 1/106 | 0/104 | 0/99 | 0/92 |
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 0/107 | 0/106 | 1/106 | 0/104 | 0/99 | 0/92 |
| OrthopnoeaRespiratory, thoracic and mediastinal disorders | 0/107 | 0/106 | 1/106 | 0/104 | 0/99 | 0/92 |
| COVID-19Infections and infestations | 1/107 | 0/106 | 0/106 | 0/104 | 0/99 | 0/92 |
| Event | Placebo (Double-blind Treatment Period) | LX9211 100 mg/10 mg (Double-blind Treatment Period) | LX9211 200 mg/20 mg (Double-blind Treatment Period) | Placebo (Single-blind Follow-up Period) | LX9211 100 mg/10 mg (Single-blind Follow-up Period) | LX9211 200 mg/20 mg Single-blind Follow-up Period) |
|---|---|---|---|---|---|---|
| DizzinessNervous system disorders | 2/107 | 16/106 | 29/106 | 2/104 | 1/99 | 1/92 |
| NauseaGastrointestinal disorders | 3/107 | 9/106 | 12/106 | 1/104 | 0/99 | 3/92 |
| HeadacheNervous system disorders | 4/107 | 9/106 | 10/106 | 2/104 | 1/99 | 0/92 |
| ConstipationGastrointestinal disorders | 3/107 | 4/106 | 8/106 | 0/104 | 0/99 | 0/92 |
| SomnolenceNervous system disorders | 0/107 | 7/106 | 2/106 | 0/104 | 0/99 | 1/92 |
| VomitingGastrointestinal disorders | 2/107 | 2/106 | 7/106 | 0/104 | 0/99 | 2/92 |
| Balance disorderNervous system disorders | 0/107 | 6/106 | 5/106 | 0/104 | 0/99 | 0/92 |
The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment.
| Age, Continuous(years) | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg | Total |
|---|---|---|---|---|
| Mean | 62.0 ± 9.59 | 62.8 ± 9.26 | 61.8 ± 10.96 | 62.2 ± 9.94 |
| Sex: Female, Male(Participants) | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg | Total |
|---|---|---|---|---|
| Female | 41 | 48 | 43 | 132 |
| Male | 66 | 58 | 63 | 187 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 23 | 13 | 18 | 54 |
| Not Hispanic or Latino | 84 | 93 | 88 | 265 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 1 | 3 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 2 |
| Black or African American | 19 | 22 | 18 | 59 |
| White | 82 | 79 | 83 | 244 |
| Other | 3 | 0 | 4 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Average Daily Pain Score (ADPS)(score on a scale) | Placebo | LX9211 100 mg/10 mg | LX9211 200 mg/20 mg | Total |
|---|---|---|---|---|
| Mean | 6.54 ± 1.154 | 6.59 ± 1.091 | 6.53 ± 1.028 | 6.55 ± 1.089 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2020 to primary completion in May 2022, 20 months.
Results were first posted in Jun 2025, 3 years 1 month after primary completion. A results delay was requested in May 2023.
Of 65 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's 20 months is above that.
Counting every sponsor, half of 147 studies reached it within 27 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pilavapadin