Phase 2
N=319
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathy · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04455633 ↗Enrolled (actual)
319
Serious AEs
1.0%
Results posted
Jun 2025
Primary outcome: Primary: Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale — -0.72; -1.39; -1.27 score on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LX9211 (Drug); LX9211 Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexicon Pharmaceuticals
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale |
-0.72; -1.39; -1.27 | 0.007 sig |
| SECONDARY Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6 |
17.8; 27.4; 17.0 | 0.091 |
| SECONDARY Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6 |
10.3; 15.1; 9.4 | 0.289 |
| SECONDARY 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 |
-0.69; -1.42; -1.38; -0.69; -1.43; -1.38 | 0.014 sig |
| SECONDARY Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy |
0; 0; 0 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Scale Score at Week 6 |
3.28; 2.93; 3.13 | 0.031 sig |
| SECONDARY 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; NA | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
32; 57; 54; 15; 21; 18 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 time of screening
- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening
- Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening
- Pain from DPN present for at least 6 months
- Haemoglobin A1C ≤11% at screening
- Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening
Exclusion Criteria
- Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
- History of major depressive episode, active, significant psychiatric disorders
- History of clinically significant drug or alcohol use disorder
- History of neurolytic or neurosurgical therapy for DPNP
- Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit
Data sourced from ClinicalTrials.gov (NCT04455633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.