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
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.
Exclusion Criteria:
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 |
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