Recruiting

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain

H0P-MC-NP01 - ClinicalTrials.gov - NCT04476108

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic pain.
How long will I be in the trial?
The study will last about 26 weeks and may include up to 8 visits.
Email
Recruiting

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain

H0P-MC-NP01 - ClinicalTrials.gov - NCT04476108

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic pain.
How long will I be in the trial?
The study will last about 26 weeks and may include up to 8 visits.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have daily pain for at least 12 weeks

Participants must have a body mass index of <40 kilograms per meter squared (kg/m²)

Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non drug pain-relieving therapies during the study

Participants must be willing to stop all pain medications for diabetic nerve pain, except for rescue medication allowed in the study

Participants must have type 1 or type 2 diabetes and stable glycemic control

Participants must NOT

Participants must not have surgery planned during the study for any reason

Have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

Participants must not have an intolerance to acetaminophen or paracetamol

Participants must not have a history of alcohol or drug disorder within 2 years

Participants must not have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy

Trial Summary

Conditions the trial is for

Diabetic Nerve Pain (Neuropathy)

What the trial is testing?

LY3016859

Could I receive a Placebo?

yes

Enrollment Goal

125

Trial Dates

July 2020 - January 2023

Trial Phase

2

Enter your postal code to find the nearest site

Think this trial might be a good fit for you?

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have daily pain for at least 12 weeks

Participants must have a body mass index of <40 kilograms per meter squared (kg/m²)

Participants must be willing to maintain any non-drug pain relieving therapies (for example, physical therapy) and not start any new non drug pain-relieving therapies during the study

Participants must be willing to stop all pain medications for diabetic nerve pain, except for rescue medication allowed in the study

Participants must have type 1 or type 2 diabetes and stable glycemic control

Participants must NOT

Participants must not have surgery planned during the study for any reason

Have had cancer within 2 years, except for certain types of skin cancer (cutaneous basal cell or squamous cell carcinoma) surgically removed

Participants must not have an intolerance to acetaminophen or paracetamol

Participants must not have a history of alcohol or drug disorder within 2 years

Participants must not have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy

Trial Summary

Conditions the trial is for

Diabetic Nerve Pain (Neuropathy)

What the trial is testing?

LY3016859

Could I receive a Placebo?

yes

Enrollment Goal

125

Trial Dates

July 2020 - January 2023

Trial Phase

2

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Trial Locations

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Diabetic Nerve Pain (Neuropathy) Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?