~182 spots leftby Jan 2026

LY3556050 for Diabetic Peripheral Neuropathic Pain

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Eli Lilly and Company
Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called LY3556050 to see if it can help reduce nerve pain in people with diabetes. The study will last several months and will compare the effects of LY3556050 to another treatment. The goal is to determine if LY3556050 is safe and effective for treating diabetic nerve pain.
What data supports the idea that LY3556050 for Diabetic Peripheral Neuropathic Pain is an effective drug?The available research does not provide specific data on the effectiveness of LY3556050 for Diabetic Peripheral Neuropathic Pain. Instead, it discusses placebo responses and the effectiveness of other treatments like duloxetine. The studies highlight that placebo responses can be significant, and real-world effectiveness of neuropathic pain medications is often less impressive than in clinical trials. Therefore, there is no direct evidence from the provided information to support the effectiveness of LY3556050 for this condition.246912
Do I need to stop my current medications for this trial?Yes, you will need to stop all medications taken for chronic pain conditions, except for those allowed by the study protocol, for the duration of the study.
Is the drug LY3556050 a promising treatment for diabetic peripheral neuropathic pain?The information provided does not mention LY3556050, so we cannot determine if it is a promising treatment for diabetic peripheral neuropathic pain based on the given articles.1581011
What safety data is available for LY3556050 in treating diabetic peripheral neuropathic pain?The provided research does not contain specific safety data for LY3556050 or its other names (LY-3556050, Placebo, Control, Dummy Treatment) in the context of diabetic peripheral neuropathic pain. The studies focus on other treatments and placebo responses, but do not mention LY3556050.137912

Eligibility Criteria

Adults with diabetic peripheral neuropathic pain (DPNP) who have had Type 1 or Type 2 Diabetes for at least 6 months, a BMI ≤45 kg/m², stable blood sugar control, and consistent pain for at least 12 weeks. Participants must not plan surgeries during the study or have certain medical conditions that could affect their participation.

Inclusion Criteria

I am willing to stop my chronic pain medications, except those allowed, for the study.
I have had daily nerve pain for at least 12 weeks.
I have had diabetic nerve pain in my legs for over 6 months.
I have had diabetic nerve pain in both of my legs for at least 6 months.
I have had daily nerve pain for at least 12 weeks.

Exclusion Criteria

I've had a procedure in the last 6 months to permanently reduce feeling in a specific area.
I am scheduled for surgery during the study period.

Treatment Details

The trial is testing LY3556050 against a placebo to see if it's safe and effective in treating DPNP. The study spans approximately six months over three periods, assessing how well LY3556050 relieves pain compared to an inactive substance.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3556050 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3556050 orally.
Group II: LY3556050 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3556050 orally.
Group III: LY3556050 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3556050 orally.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally.

Find a clinic near you

Research locations nearbySelect from list below to view details:
Clinvest Research LLCSpringfield, MO
Northern California Research - SacramentoSacramento, CA
UniMed CenterEast Brunswick, NJ
Northwestern UniversityChicago, IL
More Trial Locations
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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

References

New and emerging treatment options for neuropathic pain. [2006]A large number of neuroanatomical, neurophysiologic, and neurochemical mechanisms are thought to contribute to the development and maintenance of neuropathic pain (NP). As a result, a corresponding wide range of treatments have been employed to treat patients with NP, including antiepileptic drugs, opioid analgesics, tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, N-methyl-D-aspartate receptor antagonists, cholecystokinin receptor antagonists, adenosine, lipoic acid, cannabinoids, isosorbide dinitrate, dronabinol, capsaicin, protein kinase C inhibitors, aldose reductase inhibitors, and VR-1 receptor modulators. Many of these compounds are limited by marginal efficacy and clinically significant adverse events; few have been evaluated in well-controlled, large-scale clinical trials. At present, the only agents approved for the treatment of painful diabetic peripheral neuropathy and postherpetic neuralgia are lidocaine patches 5%, duloxetine, gabapentin, and pregabalin. Of these, only pregabalin is indicated for both conditions.
Duloxetine for the management of diabetic peripheral neuropathic pain: evaluation of functional outcomes. [2022]To assess the effectiveness of duloxetine, compared with placebo, on patient-reported health outcomes over a 12-week period, in the management of diabetic peripheral neuropathic pain (DPNP).
Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. [2022]To assess efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in patients with peripheral neuropathic pain.
Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis. [2022]To compare placebo responses in neuropathic pain syndromes.
New and developing drugs for the treatment of neuropathic pain in diabetes. [2021]A number of agents from diverse pharmacological classes are used to treat neuropathic pain associated with diabetic peripheral neuropathy. Only three of these have regulatory approval for this indication in the U.S. In this focused article, I will discuss selected drugs, newly approved or in development, to treat neuropathic pain in patients with diabetic neuropathy. These will include agonists and antagonists of the transient receptor potential channels, a family of receptor proteins that play a role in the transduction of physical stress; sodium channel isoform specific antagonists; a recently approved dual-action opioid receptor agonist-norepinephrine reuptake inhibitor; gene therapy for neuropathic pain; and anti-nerve growth factor molecules. Mechanisms of action, preclinical supporting data, clinical trial evidence, and adverse effects will be reviewed.
Chronic pain with neuropathic characteristics in diabetic patients: a French cross-sectional study. [2022]Our aim was to estimate the prevalence of distal chronic pain with neuropathic characteristics in patients with type 1 and type 2 diabetes mellitus and its impact on quality of life, mood, anxiety, sleep and healthcare utilization.
Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. [2022]The safety and tolerability of three treatments for diabetic peripheral neuropathic pain (DPNP) were compared.
Fulranumab for treatment of diabetic peripheral neuropathic pain: A randomized controlled trial. [2021]To assess efficacy and safety of fulranumab, a fully human monoclonal antibody against nerve growth factor, in patients with diabetic peripheral neuropathic pain (DPNP).
The utility/futility of medications for neuropathic pain - an observational study. [2021]Background and aims The RELIEF (Real Life) study by AstraZeneca was designed as an observational study to validate a series of Patient Reported Outcome (PRO) questionnaires in a mixed population of subjects with neuropathic pain (NP) coming from diabetes, neurology and primary care clinics. This article is an analysis of a subset of the information to include the medications used and the effects of pharmacological treatment over 6 months. The RELIEF study was performed during 2010-2013. Methods Subjects were recruited from various specialty clinics and one general practice clinic across Canada. The subjects were followed for a total of 2 years with repeated documentation of their status using 10 PROs. A total of 210 of the recruited subjects were entered into the data base and analyzed. Of these, 123 had examination-verified painful diabetic neuropathy (PDN) and 87 had examination-verified post-traumatic neuropathy (PTN). To evaluate the responsiveness of the PROs to change, several time points were included and this study focusses primarily on the first 6 months. Subjects also maintained a diary to document all medications, both for pain and other medical conditions, including all doses, start dates and stop dates, that could be correlated to changes in the PRO parameters. Results RELIEF was successful in being able to correlate the validity of the PROs and this data was used for further AstraZeneca Phase 1, 2, and 3 clinical trials of NP. To our surprise, there was very little change in pain and low levels of patient satisfaction with treatment during the trial. Approximately 15% of the subjects reported improvement, 8% worsening of pain, the remainder reported pain unchanged despite the use of multiple medications at multiple doses, alone or in combination with frequent changes of medications and doses over the study. Those taking predominantly NSAIDs (COX-inhibitors) did no worse than those taking the standard recommended medications against NP. Conclusions Since this is a real-life study, it reflects the clinical utility of a variety of internationally recommended medications for the treatment of NP. In positive clinical trials of these medications in selected "ideal" subjects, the effects are not overwhelming - 30% are 50% improved on average. This study shows that in the real world the results are not nearly as positive and reflects information from non-published negative clinical trials. Implications We still do not have very successful medications for NP. Patients probably differ in many respects from those subjects in clinical trials. This is not to negate the use of recommended medications for NP but an indication that success rates of treatment are likely to be worse than the data coming from those trials published by the pharmaceutical industry.
Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients. [2023]Label="AIMS/INTRODUCTION" NlmCategory="OBJECTIVE">This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α2 δ subunit of voltage-dependent Ca2+ channels, for the treatment of diabetic peripheral neuropathic pain (DPNP).
Long-term safety and efficacy of mirogabalin in Asian patients with diabetic peripheral neuropathic pain. [2022]Label="AIMS/INTRODUCTION" NlmCategory="OBJECTIVE">Diabetic peripheral neuropathic pain (DPNP) affects the functionality, mood and sleep patterns of patients with diabetes. Mirogabalin, an α2 δ ligand with a slower dissociation for α2 δ-1 versus α2 δ-2 subunits, showed efficacy and safety in a randomized, double-blind, placebo-controlled, 14-week study in Asian patients with DPNP. This open-label extension study evaluated the long-term safety and efficacy of mirogabalin in Asian patients with DPNP.
12.United Statespubmed.ncbi.nlm.nih.gov
Placebo and nocebo responses in painful diabetic neuropathy: systematic review and meta-analysis. [2023]This preregistered (CRD42021223379) systematic review and meta-analysis aimed to characterize the placebo and nocebo responses in placebo-controlled randomized clinical trials (RCTs) on painful diabetic neuropathy (PDN), updating the previous literature by a decade. Four databases were searched for PDN trials published in the past 20 years, testing oral medications, adopting a parallel-group design. Magnitude of placebo or nocebo responses, Cochrane risk of bias, heterogeneity, and moderators were evaluated. Searches identified 21 studies (2425 placebo-treated patients). The overall mean pooled placebo response was -1.54 change in the pain intensity from baseline [95% confidence interval (CI): -1.52, -1.56, I2 = 72], with a moderate effect size (Cohen d = 0.72). The pooled placebo 50% response rate was 25% [95% CI: 22, 29, I2 = 50%]. The overall percentage of patients with adverse events (AEs) in the placebo arms was 53.3% [95% CI: 50.9, 55.7], with 5.1% [95% CI: 4.2, 6] of patients dropping out due to AEs. The year of study initiation was the only significant moderator of placebo response (regression coefficient = -0.06, [95% CI: -0.10, -0.02, P = 0.007]). More recent RCTs tended to be longer, bigger, and to include older patients (N = 21, rs = 0.455, P = 0.038, rs = 0.600, P = 0.004, rs = 0.472, P = 0.031, respectively). Our findings confirm the magnitude of placebo and nocebo responses, identify the year of study initiation as the only significant moderator of placebo response, draw attention to contextual factors such as confidence in PDN treatments, patients' previous negative experiences, intervention duration, and information provided to patients before enrollment.