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LX9211 High Dose for Diabetic Neuropathy (PROGRESS Trial)

Phase 2
Recruiting
Research Sponsored by Lexicon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening
Adult male and female participants ≥18 years of age at the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

PROGRESS Trial Summary

This trial aims to determine if a medication called LX9211 is effective in reducing a condition called DPNP.

Who is the study for?
Adults over 18 with a BMI between 18.0 and 40.0 kg/m^2, diagnosed with type 1 or type 2 diabetes and suffering from chronic diabetic peripheral neuropathic pain for at least six months can join this study. They must have stable diabetes management for three months and an A1C level of ≤11%. People using opioids, neurolytic therapies, topical analgesics for neuropathy recently, or NSAIDs within two weeks cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new medication called LX9211 against a placebo in reducing pain caused by diabetic peripheral neuropathy. Participants won't know if they're receiving the actual drug or the placebo as both are blinded.See study design
What are the potential side effects?
While specific side effects of LX9211 aren't listed here, common side effects in trials like this may include headache, dizziness, nausea, fatigue, and potential allergic reactions to the medication components.

PROGRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes (type 1 or 2) with chronic nerve pain.
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I am 18 years old or older.
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I have had pain from diabetic nerve damage for at least 6 months.

PROGRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
Secondary outcome measures
Change from Baseline to Week 8 in Burning Pain
Change from Baseline to Week 8 in Pain Interference on Sleep
Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score
+1 more

PROGRESS Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LX9211 Low DoseExperimental Treatment1 Intervention
LX9211 low dose, orally, once daily during a blinded treatment period.
Group II: LX9211 High Dose Followed by Low DoseExperimental Treatment1 Intervention
LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
Group III: LX9211 High DoseExperimental Treatment1 Intervention
LX9211 high dose, orally, once daily during a blinded treatment period.
Group IV: LX9211 PlaceboPlacebo Group1 Intervention
LX9211 matching placebo, orally, once daily during a blinded treatment period.

Find a Location

Who is running the clinical trial?

Lexicon PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
23,174 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist participants for this trial?

"Based on the information available on clinicaltrials.gov, this particular trial is not currently seeking participants. Although it was initially posted on November 29th, 2023 and last updated on January 2nd, 2024, patient enrollment is presently closed. However, there are a total of 167 other ongoing studies actively recruiting patients at this time."

Answered by AI

What level of risk does LX9211 Low Dose pose to patients?

"Based on our assessment at Power, the safety rating for LX9211 Low Dose is 2. This determination aligns with the Phase 2 trial design, where there is existing data supporting safety but no evidence yet regarding efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Lexicon Investigational Site (105)
Lexicon Investigational Site (126)
Lexicon Investigational Site (120)
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I tried all types of medications and nothing had worked.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
2023. "A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203002.
All > Nerve Pain > Greensboro
~277 spots leftby Mar 2025
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