A Dose-ranging Study in Patients with Diabetic Peripheral Neuropathic Pain (DPNP) (PROGRESS)

Lexicon Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: LX9211 (blinded); Drug: Placebo (blinded)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06203002

LX9211.204-DPN (Other Identifier)

LX9211.1-204-DPN

Details and patient eligibility

About

Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/

Enrollment: 416 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant has given written informed consent to participate in the study in accordance with local regulations
2. Adult male and female participants ≥18 years of age at the Screening Visit
3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
5. Pain from DPNP present for at least 6 months prior to Screening
6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
8. Willing to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion criteria

1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP
2. History of neurolytic or neurosurgical therapy for DPNP
3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit.
4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening
5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 4 patient groups, including a placebo group

LX9211 Low Dose

Experimental group

Description:

LX9211 low dose, orally, once daily during a blinded treatment period.

Treatment:

Drug: LX9211 (blinded)

LX9211 High Dose

Experimental group

Description:

LX9211 high dose, orally, once daily during a blinded treatment period.

Treatment:

Drug: LX9211 (blinded)

LX9211 High Dose Followed by Low Dose

Experimental group

Description:

LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.

Treatment:

Drug: LX9211 (blinded)

LX9211 Placebo

Placebo Comparator group

Description:

LX9211 matching placebo, orally, once daily during a blinded treatment period.

Treatment:

Drug: Placebo (blinded)