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COMPLETED Phase 2

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

NCT04455633 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG LX9211
  • DRUG LX9211 Matching Placebo

Study Locations (20)

Florida

  • Lexicon Investigational Site — Brandon
  • Lexicon Investigational Site — Fort Myers
  • Lexicon Investigational Site — Jacksonville
  • Lexicon Investigational Site — Lake City
  • Lexicon Investigational Site — New Port Richey
  • Lexicon Investigational Site — Ormond Beach
  • Lexicon Investigational Site — Winter Park

California

  • Lexicon Investigational Site — Anaheim
  • Lexicon Investigational Site — Greenbrae
  • Lexicon Investigational Site — Los Angeles
  • Lexicon Investigational Site — North Hollywood
  • Lexicon Investigational Site — Sacramento
  • Lexicon Investigational Site — Tustin

Arizona

  • Lexicon Investigational Site — Chandler
  • Lexicon Investigational Site — Glendale
  • Lexicon Investigational Site — Kingman
  • Lexicon Investigational Site — Tucson

Alabama

  • Lexicon Investigational Site — Mobile

Georgia

  • Lexicon Investigational Site — Macon

Indiana

  • Lexicon Investigational Site — Evansville

Trial Details

FieldValue
Enrollment Target 319 participants
Start Date 2020-09-03
Est. Completion 2022-06-28
Phase Phase 2

Sponsor

Lexicon Pharmaceuticals

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04455633

The ClinicalTrials.gov registry entry for NCT04455633 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions — of which LX9211 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04455633 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04455633 about?

NCT04455633 is a clinical study titled "Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain". 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.

What is the current status of trial NCT04455633?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 319 participants. The study started on 2020-09-03. Estimated completion is 2022-06-28.

What conditions does trial NCT04455633 study?

This clinical trial studies the following conditions: Diabetes, Diabetic Peripheral Neuropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04455633?

The interventions under investigation include: LX9211 (DRUG), LX9211 Matching Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04455633?

This trial is sponsored by Lexicon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04455633 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial