What side effects are associated with this type of intervention?

Common treatments for diabetic neuropathy include antidepressants such as amitriptyline, desipramine, and duloxetine, and anticonvulsants like pregabalin and gabapentin. Antidepressants can cause side effects such as dry mouth, constipation, urinary retention, blurred vision, weight gain, and drowsiness. Duloxetine may also lead to nausea, fatigue, and increased sweating. Anticonvulsants like pregabalin and gabapentin can cause dizziness, drowsiness, peripheral edema, and weight gain. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Diabetic Neuropathy, particularly for managing neuropathic pain. Pregabalin (Lyrica) and duloxetine (Cymbalta) are two prominent medications that have been approved for this purpose. Pregabalin works by modulating calcium channels to reduce nerve pain, while duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that helps alleviate pain by increasing the levels of neurotransmitters in the brain. These treatments aim to manage the symptoms of diabetic neuropathy, providing pain relief and improving the quality of life for patients.

What other types of research exist?

A promising alternative to LY3556050 for diabetic neuropathy patients could be BR103354, a novel fibroblast activation protein (FAP) inhibitor with anti-diabetic effects. Additionally, CGP-60474, identified as a potent anti-endotoxemic agent, may offer therapeutic benefits due to its anti-inflammatory properties. Both agents have shown potential in related conditions and could be considered for further investigation in diabetic neuropathy treatment.

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LY3556050 for Diabetic Peripheral Neuropathic Pain

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are willing to discontinue all medications taken for chronic pain conditions, except allowed concomitant pain medication permitted per protocol, for the duration of the study

History of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history

Must not have

Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.

Have a surgery planned during the study for any reason.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of LY3556050 are not listed here, common side effects from similar medications may include dizziness, sleepiness, nausea, headache, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to stop my chronic pain medications, except those allowed, for the study.

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I have had daily nerve pain for at least 12 weeks.

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I have had diabetic nerve pain in my legs for over 6 months.

Select...

I have had diabetic nerve pain in both of my legs for at least 6 months.

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I have had daily nerve pain for at least 12 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've had a procedure in the last 6 months to permanently reduce feeling in a specific area.

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I am scheduled for surgery during the study period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 2 trial • 202 Patients • NCT04627038

21%

Constipation

19%

Nausea

16%

Dizziness

14%

Fatigue

10%

Diarrhoea

Abdominal pain upper

Headache

Abdominal discomfort

Lethargy

Dyspepsia

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

LY3556050 600 mg

Placebo

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3556050

2021

Completed Phase 2

~520

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Neuropathy include antiepileptic drugs like pregabalin and gabapentin, which inhibit calcium channels to reduce neurotransmitter release and neuronal excitability, and antidepressants such as duloxetine and amitriptyline, which inhibit the reuptake of serotonin and norepinephrine to enhance pain modulation pathways. These mechanisms are crucial for diabetic neuropathy patients as they target the underlying pathophysiological processes of neuropathic pain, providing symptomatic relief and improving quality of life.

Neuropathic Pain: Mechanism-Based Therapeutics.