Diabetic Peripheral Neuropathic PainPhase 2NCT05620576
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).
A Phase 2 study testing LY3857210 in people with Diabetic Peripheral Neuropathic Pain, run by Eli Lilly and Company at 30 sites in 2 countries.
Trial summary
This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- LY3857210
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 14 Nov 2022to 1 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a visual analog scale (VAS) pain value greater than or equal to (≥) 40 and less than (<) 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).
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- Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
- Have stable glycemic control as indicated by a glycated hemoglobin less than or equal to (≤) 11 at time of screening.
- Are men, or women able to abide by reproductive and contraceptive requirements.
Who cannot join
- 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 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.
- Have fibromyalgia.
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- 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 seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged. unconsciousness), intracranial neoplasm or hemorrhage.
- Are pregnant or breastfeeding.
- Have known or history of gastric or duodenal ulcers.
- Have known or history of inflammatory bowel disease (including ulcerative colitis or Crohn's disease).
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States28 sites
FutureSearch Trials of Neurology
Austin, Texas, 78731
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Northwest Clinical Research Center
Bellevue, Washington, 98007
Boston Clinical Trials
Boston, Massachusetts, 02131
Synexus Clinical Research US, Inc.
Chandler, Arizona, 85224
Northwestern University
Chicago, Illinois, 60611
StudyMetrix Research
City of Saint Peters, Missouri, 63303
META Medical Research Institute
Dayton, Ohio, 45432
Accel Research Sites- Clinical Research Unit
DeLand, Florida, 32720
Altoona center for clinical research
Duncansville, Pennsylvania, 16635
Lillestol Research
Fargo, North Dakota, 58104
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Suncoast Research Group
Miami, Florida, 33135
University of Miami Don Suffer Clinical Research Building
Miami, Florida, 33136
New Horizon Research Center
Miami, Florida, 33165
Renstar Medical Research
Ocala, Florida, 34470
Synexus Clinical Research US, Inc - Orlando
Orlando, Florida, 32806
Arizona Research Center
Phoenix, Arizona, 85053
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, 33781
Rainier Clinical Research Center
Renton, Washington, 98057
Artemis Institute for Clinical Research
Riverside, California, 92503
Synexus Clinical Research - St. Petersburg
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
Clinvest Headlands Llc
Springfield, Missouri, 65807
MedVadis Research Corporation
Waltham, Massachusetts, 02451
North Georgia Clinical Research
Woodstock, Georgia, 30189
Puerto Rico2 sites
Ponce Medical School Foundation Inc.
Ponce, 00716
Latin Clinical Trial Center
San Juan, 00909
About this study
Official title: Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3857210 for the Treatment of Diabetic Peripheral Neuropathic Pain
This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- LY3857210, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3857210Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 45 mg LY3857210 | Experimental | Participants received 45 milligram (mg) of LY3857210 orally once daily for up to 8 weeks. Receives: Drug: LY3857210 |
| Placebo | Placebo comparator | Participants received placebo orally once daily for up to 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.
Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Secondary outcomes (7)
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGIC)
Patient's global impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse.
Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Change From Baseline for Worst Pain Intensity as Measured by NRS
The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine.
Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Change From Baseline on the Visual Analog Scale (VAS) for Pain
VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0 = no pain, and 100 = worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.
Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.
Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.
Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Baseline, Week 8
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
Total amount of rescue medication use as measured by average daily dosage. Posterior mean and 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start14 Nov 2022
- Primary completion19 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620576
- Sponsor's protocol ID
- 18340
- Other IDs
- H0P-MC-NP05
- Status last verified
- Jul 2024
- First submitted
- 11 Nov 2022
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3857210 for the Treatment of Diabetic Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05620576
- Acronym / sponsor ID
- 18340
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 45 mg LY3857210 | Experimental | Drug: LY3857210Participants received 45 milligram (mg) of LY3857210 orally once daily for up to 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally once daily for up to 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a visual analog scale (VAS) pain value greater than or equal to (≥) 40 and less than (<) 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.
Key exclusion criteria (16 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3857210Administered orally | Drug | 45 mg LY3857210 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time frame: Baseline, Week 8
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
7 secondary outcomes
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
Time frame: Baseline, Week 8
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGIC)
Time frame: Baseline, Week 8
Change From Baseline for Worst Pain Intensity as Measured by NRS
Time frame: Baseline, Week 8
Change From Baseline on the Visual Analog Scale (VAS) for Pain
Time frame: Baseline, Week 8
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep
Time frame: Baseline, Week 8
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
Time frame: Baseline, Week 8
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetic Peripheral Neuropathic Pain
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Diabetic Peripheral Neuropathic Pain
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Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
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Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3857210 in people with Diabetic Peripheral Neuropathic Pain, run by Eli Lilly and Company at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.