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Small Molecule

GSK3858279 for Diabetic Neuropathy (NEPTUNE-17 Trial)

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
Must not have
Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 weeks

Summary

This trial studies an experimental drug to help manage chronic pain caused by diabetes in adults. The primary goal is to assess its effectiveness.

Who is the study for?
Adults aged 18-75 with Type I or II diabetes and chronic pain from Diabetic Peripheral Neuropathic Pain (DPNP) can join this study. They should have a BMI of 18-40 kg/m^2, experience consistent pain intensity, and be able to consent. Those with cardiovascular, renal, gastrointestinal issues or other causes of neuropathy are excluded.
What is being tested?
The trial is testing GSK3858279's effectiveness in managing DPNP against a placebo. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real drug versus the placebo until after results are collected.
What are the potential side effects?
While specific side effects for GSK3858279 aren't listed here, common ones for new drugs may include allergic reactions, potential organ inflammation due to immune response changes, fatigue, digestive discomforts like nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
Select...
I have diabetes with painful nerve damage in my hands and feet for at least 6 months.
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My average daily pain level is between 4 and 9 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have nerve pain in my hands or feet not caused by diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)
Secondary study objectives
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
Average concentration over a dosing interval (Cavg) of GSK3858279
Change from baseline in the Short-Form McGill Pain Questionnaire total score over time
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK3858279 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 2.
Group II: GSK3858279 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK3858279 dose 1.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3858279
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,806 Previous Clinical Trials
8,380,609 Total Patients Enrolled
23 Trials studying Pain
3,090 Patients Enrolled for Pain
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,649 Total Patients Enrolled
20 Trials studying Pain
2,877 Patients Enrolled for Pain
~80 spots leftby Jun 2025
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