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Completed

NCT Number: NCT06203002

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

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

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lexicon Investigational Site (128), Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Screening Visit
  • Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening
  • Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
  • Pain from DPNP present for at least 6 months prior to Screening
  • At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%.
  • Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening
  • Willing to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion criteria

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

Treatment and study plan

Placebo (blinded)

Drug

LX9211 matching placebo tablets

LX9211 (blinded)

Drug

LX9211 (blinded) tablets

Primary outcomes

  1. Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)

    Time frame: Baseline, Week 8

    ADPS is based on the 11-point numerical rating scale (NRS) [0 (no pain) to 10 (worst imaginable pain)].

Secondary outcomes

  1. Change from Baseline to Week 8 in Burning Pain

    Time frame: Baseline, Week 8

    Burning pain is based on the 11-point NRS (0 [no burning] to 10 [worst burning imaginable]).

  2. Change from Baseline to Week 8 in Pain Interference on Sleep

    Time frame: Baseline, Week 8

    Pain interference on sleep is based on the 11-point NRS (0 [does not interfere] to 10 [completely interferes]).

  3. Patient Global Impression of Change (PGIC) Score at Week 8

    Time frame: Week 8

    The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse.

  4. Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score

    Time frame: Baseline, Week 8

    NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS)

Acronym: PROGRESS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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