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Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain

Sponsored by Lexicon Pharmaceuticals

About this trial

Last updated 2 years ago

Study ID

LX9211.1-201-DPN

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period.

What are the participation requirements?

Yes

Inclusion Criteria

- Patient has given written informed consent to participate in the study in accordance with local regulations

- Adult male and female patients ≥18 years of age at the time of screening

- Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening

- Diagnosis of DPNP at Screening

- Pain from DPN present for at least 6 months

- A1C ≤11% at screening

- Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening

No

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 NSAIDs less than 2 weeks prior to the Screening Visit

Locations

Location

Status