Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Diabetic Peripheral Neuropathic Pain (DPNP), which is a type of nerve pain that affects people with diabetes. The study will evaluate a new treatment called GSK3858279, which is administered as an injection. This treatment is being compared to a placebo to understand its effectiveness in reducing pain for individuals with DPNP.

The purpose of the study is to assess how well GSK3858279 works in managing pain associated with DPNP. Participants in the study will receive either the new treatment or a placebo. The study will last for a period of 12 weeks, during which participants will be monitored to see how their pain levels change over time. The study aims to provide valuable information on the safety and potential benefits of this new treatment for people suffering from DPNP.

Throughout the study, participants will receive regular check-ups and assessments to ensure their well-being and to gather data on the treatment's effects. This trial is an important step in exploring new options for managing pain in individuals with diabetic nerve pain, potentially leading to improved quality of life for those affected by this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, including age, diabetes type, and pain characteristics.

    A detailed medical history is reviewed, and a physical examination is conducted. A pain questionnaire is completed to assess the level of pain experienced.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to record the initial pain levels using a Numeric Rating Scale (NRS). This scale ranges from 0 to 10, where 0 means no pain and 10 means the worst possible pain.

    Additional tests may be performed to ensure all health parameters are within the required range for participation.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either the study medication, GSK3858279, or a placebo. This is done in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being administered.

    The medication is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol and are explained during this phase.

  4. Step 4

    Treatment period

    The treatment period lasts for a specified duration, during which the medication is administered regularly as per the study schedule.

    Participants are required to maintain a stable anti-diabetic medication regimen and report any changes in their condition or medication use.

  5. Step 5

    Regular assessments

    Regular assessments are conducted to monitor pain levels and any side effects. These assessments include completing the pain questionnaire and other evaluations as required.

    Participants are asked to use a patient eDiary to record daily pain levels and any use of rescue medication.

  6. Step 6

    Final assessment

    At the end of the treatment period, a final assessment is conducted to evaluate changes in pain levels compared to the baseline.

    The results are used to determine the efficacy of the study medication in managing diabetic peripheral neuropathic pain.

  7. Step 7

    Follow-up

    A follow-up period is included to monitor any long-term effects of the treatment. Participants may be required to attend additional visits or complete further assessments.

    The study team provides guidance on any necessary actions or precautions to be taken after the study concludes.

Who can join the trial?

14 criteria

  • Age between 18 and 75 years old at the time of signing the consent form.
  • Have Type I or Type II diabetes with painful nerve damage in the feet or legs due to diabetes for at least 6 months.
  • Pain must have started in both lower legs and is not due to infection or injury.
  • Diagnosis confirmed by a positive result on a specific questionnaire for nerve pain.
  • Blood sugar levels, measured by HbA1c, must be less than 97 mmol/mol (less than 11%).
  • On a stable diabetes medication plan for at least 30 days before the study starts. Adjusting insulin dose is okay, but starting insulin treatment is not allowed within 30 days before the study.
  • No recent unplanned hospital visits due to not following diabetes treatment or uncontrolled diabetes.
  • Pain score between 4 and 9 on a scale from 0 to 10 for average daily pain over the past 24 hours at screening.
  • During the initial study period, average daily pain score must also be between 4 and 9 on the same scale. Use of additional pain medication must be within allowed limits.
  • History of not getting enough pain relief from, or not being able to tolerate, or having a reason not to use current standard pain treatments like certain antidepressants or anticonvulsant drugs.
  • Willing and able to understand and participate in all study evaluations and complete all required tests and procedures, including using a patient diary.
  • BMI (Body Mass Index) must be between 18 and 40 kg/m2.
  • Male or female participants. Female participants must not be pregnant or breastfeeding and must meet specific conditions regarding pregnancy prevention and testing.
  • Capable of giving signed informed consent and willing to follow the study requirements and restrictions.

Who cannot join the trial?

3 criteria

  • Patients who do not have Diabetic Peripheral Neuropathic Pain cannot participate. This is a type of pain caused by nerve damage due to diabetes.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population may not be eligible. This includes groups that might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

GSK3858279 is a medication being studied for its potential to help people with chronic Diabetic Peripheral Neuropathic Pain, which is a type of nerve pain that can occur in people with diabetes. This medication is being tested to see if it can reduce pain levels in patients who suffer from this condition. The study aims to understand how well the medication works, how safe it is, and how the body processes it. Participants in the trial receive this medication to see if it can effectively manage their pain compared to those who do not receive it.

What is already known about the treatment

GSK3858279 – This medication is administered orally in the form of a tablet and is currently being studied in clinical trials for its effectiveness in treating chronic Diabetic Peripheral Neuropathic Pain (DPNP). It is not yet widely available in medical practice, as it is still under investigation to determine its safety and efficacy. The main therapeutic indication for GSK3858279 is to alleviate pain associated with DPNP. At the molecular level, it works by targeting specific pathways involved in pain signaling, although the exact mechanism is still being researched. It is classified pharmacologically as an investigational drug, meaning it is still being tested and is not yet approved for general use.

Investigated diseases

Diabetic Peripheral Neuropathic Pain – Diabetic Peripheral Neuropathic Pain is a condition that occurs as a complication of diabetes, affecting the nerves outside the brain and spinal cord. It primarily involves damage to the peripheral nerves, leading to symptoms such as pain, tingling, and numbness, usually in the feet and hands. The progression of this condition is often gradual, with symptoms worsening over time if blood sugar levels are not well controlled. The pain associated with this condition can vary in intensity and may be described as burning, stabbing, or shooting. As the condition progresses, it can lead to a loss of sensation in the affected areas, increasing the risk of injury. Managing blood sugar levels is crucial in slowing the progression of nerve damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502313-28-00Protocol code214221Estimated enrolment240 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).