Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetic Peripheral Neuropathy

Treatments: Drug: LX9211; Drug: LX9211 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04455633

LX9211.1-201-DPN

LX9211.201 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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319 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: LX9211 Matching Placebo

LX9211 100 mg/10 mg

Experimental group

Description:

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.

Treatment:

Drug: LX9211

LX9211 200 mg/20 mg

Experimental group

Description:

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.

Treatment:

Drug: LX9211