Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04707157 |
Recruitment Status :
Recruiting
First Posted : January 13, 2021
Last Update Posted : April 19, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Peripheral Neuropathic Pain | Drug: LY3556050 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain |
Actual Study Start Date : | May 6, 2021 |
Estimated Primary Completion Date : | May 26, 2023 |
Estimated Study Completion Date : | May 26, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: LY3556050
LY3556050 given orally
|
Drug: LY3556050
given orally |
Placebo Comparator: Placebo
Placebo given orally
|
Drug: Placebo
given orally |
- Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [ Time Frame: Baseline, up to Week 8 ]Change from Baseline in Average Pain Intensity as Measured by the NRS
- Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score [ Time Frame: Baseline, up to Week 8 ]Change from Baseline in the BPI-SF Total Interference Score
- Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change [ Time Frame: Baseline, up to Week 8 ]Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
- Change from Baseline for Worst Pain Intensity as Measured by NRS [ Time Frame: Baseline, up to Week 8 ]Change from Baseline for Worst Pain Intensity as Measured by NRS
- Change from Baseline on the Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline, up to Week 8 ]Change from Baseline on the Visual Analog Scale (VAS) for Pain
- Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [ Time Frame: Baseline, up to Week 8 ]Change from Baseline on the Sleep Scale from the MOS Sleep Scale
- Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to Week 8 ]Change from Baseline on the EQ-5D-5L
- Total Amount of Rescue Medication [ Time Frame: Baseline, up to Week 8 ]Total Amount of Rescue Medication

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
- Have a history of daily pain for at least 12 weeks based on participant report or medical history.
- Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
- Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
- Are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study.
- Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
- Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
- Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria:
- 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 surgery planned during the study for any reason, related or not to the disease state under evaluation.
- Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
- Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- Have a positive human immunodeficiency virus (HIV) test result at screening.
- Have an intolerance to acetaminophen or paracetamol or any of its excipients.
- Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
- Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
- Have known hereditary motor, sensory or autonomic neuropathies.
- Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
- Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
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Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.
- Have a history or presence of lactic acidosis.
- Have a history or presence of severe hepatic disease including cirrhosis.
- Have uncontrolled or unstable congestive heart failure.
- Are taking carbonic anhydrase inhibitors if also taking metformin.
- Have had a change in metformin therapy in the last 12 weeks.
- Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
- Are pregnant or breastfeeding.
- Have fibromyalgia.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707157
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04707157 |
Other Study ID Numbers: |
17514 H0P-MC-NP03 ( Other Identifier: Eli Lilly and Company ) |
First Posted: | January 13, 2021 Key Record Dates |
Last Update Posted: | April 19, 2022 |
Last Verified: | April 15, 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neuralgia Diabetic Neuropathies Chronic Pain Pain Neurologic Manifestations Peripheral Nervous System Diseases |
Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |