A Phase 2 interventional study of LY3526318 and Placebo in Diabetic Peripheral Neuropathic Pain, sponsored by Eli Lilly and Company. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). 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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 155 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.
Drug: LY3526318
Participants received placebo orally, once daily, for 8-weeks treatment period.
Drug: Placebo
Administered orally
Administered orally
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 intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Time frame: Baseline, Week 4
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% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Time frame: Baseline, Week 8
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.
Time frame: Baseline, Week 4
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.
Time frame: Baseline, Week 8
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Patients 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.
Time frame: Baseline, Week 4
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Patients 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.
Time frame: 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.
Time frame: Baseline, Week 4
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.
Time frame: 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.
Time frame: Baseline, Week 4
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.
Time frame: 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.
Time frame: Baseline, Week 4
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.
Time frame: 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, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Time frame: Week 4
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, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
Time frame: 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.
Time frame: Baseline, Week 4
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.
Time frame: Baseline, Week 8
| Milestone | 250 Milligram (mg) LY3526318 | Placebo |
|---|---|---|
| Started | 103 | 52 |
| Received at least one dose of study drug (safety population week 1-4) | 102 | 52 |
| Safety population week 5-8 | 95 | 46 |
| Completed | 88 | 43 |
| Not completed | 15 | 9 |
| Withdrew: Adverse event | 5 | 5 |
| Withdrew: Non-compliance with study drug and procedures | 0 | 1 |
| Withdrew: Protocol deviation | 3 | 0 |
| Withdrew: Withdrawal by subject | 6 | 3 |
| Withdrew: Participant could not tolerate long study visits | 1 | 0 |
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 intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | -1.50 (-1.81 to -1.19) | -1.35 (-1.80 to -0.90) |
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% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | -1.80 (-2.17 to -1.42) | -1.78 (-2.32 to -1.24) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | -1.54 (-1.90 to -1.17) | -1.41 (-1.90 to -0.91) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | -1.69 (-2.14 to -1.25) | -1.43 (-2.05 to -0.81) |
Patients 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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | 2.77 (2.55 to 3.00) | 2.99 (2.67 to 3.31) |
Patients 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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change | 2.77 (2.54 to 3.01) | 2.94 (2.61 to 3.28) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline for Worst Pain Intensity as Measured by NRS | -1.48 (-1.81 to -1.15) | -1.36 (-1.83 to -0.88) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline for Worst Pain Intensity as Measured by NRS | -1.68 (-2.09 to -1.26) | -1.74 (-2.32 to -1.14) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the Visual Analog Scale (VAS) for Pain | -21.84 (-26.33 to -17.38) | -18.75 (-24.99 to -12.55) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the Visual Analog Scale (VAS) for Pain | -23.11 (-28.31 to -17.95) | -21.61 (-28.74 to -14.50) |
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.
| hours per night | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | 0.40 (0.14 to 0.66) | 0.29 (-0.07 to 0.65) |
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.
| hours per night | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep | 0.45 (0.17 to 0.74) | 0.25 (-0.13 to 0.63) |
Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| mg per day (mg/day) | 250 mg LY3526318 | Placebo |
|---|---|---|
| Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | 255.71 (163.50 to 347.62) | 211.35 (81.10 to 342.14) |
Total amount of rescue medication use as measured by average daily dosage. Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| mg/day | 250 mg LY3526318 | Placebo |
|---|---|---|
| Total Amount of Rescue Medication Use as Measured by Average Daily Dosage | 138.75 (62.87 to 215.62) | 237.51 (126.82 to 346.84) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | 0.04 (-0.00 to 0.08) | 0.03 (-0.02 to 0.09) |
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.
| score on a scale | 250 mg LY3526318 | Placebo |
|---|---|---|
| Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm) | 0.05 (-0.01 to 0.10) | 0.05 (-0.02 to 0.13) |
Collected over Baseline through Week 8. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 250 mg LY3526318 Week 1-4 | 0/102 (0%) | 2/102 (2%) | 40/102 (39.2%) |
| 250 mg LY3526318/Placebo Week 5-8 | 0/95 (0%) | 3/95 (3.2%) | 23/95 (24.2%) |
| Placebo Week 1-4 | 0/52 (0%) | 1/52 (1.9%) | 22/52 (42.3%) |
| Placebo Week 5-8 | 0/46 (0%) | 1/46 (2.2%) | 10/46 (21.7%) |
| Event | 250 mg LY3526318 Week 1-4 | 250 mg LY3526318/Placebo Week 5-8 | Placebo Week 1-4 | Placebo Week 5-8 |
|---|---|---|---|---|
| Road traffic accidentInjury, poisoning and procedural complications | 0/102 | 0/95 | 0/52 | 1/46 |
| Skin abrasionInjury, poisoning and procedural complications | 0/102 | 0/95 | 0/52 | 1/46 |
| Skin lacerationInjury, poisoning and procedural complications | 0/102 | 0/95 | 0/52 | 1/46 |
| CellulitisInfections and infestations | 0/102 | 2/95 | 0/52 | 0/46 |
| Acute myocardial infarctionCardiac disorders | 0/102 | 0/95 | 1/52 | 0/46 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/102 | 1/95 | 0/52 | 0/46 |
| Chest painGeneral disorders | 1/102 | 0/95 | 0/52 | 0/46 |
| ContusionInjury, poisoning and procedural complications | 1/102 | 0/95 | 0/52 | 0/46 |
| Transient ischaemic attackNervous system disorders | 1/102 | 0/95 | 0/52 | 0/46 |
| Event | 250 mg LY3526318 Week 1-4 | 250 mg LY3526318/Placebo Week 5-8 | Placebo Week 1-4 | Placebo Week 5-8 |
|---|---|---|---|---|
| HeadacheNervous system disorders | 3/102 | 0/95 | 4/52 | 1/46 |
| DiarrhoeaGastrointestinal disorders | 5/102 | 0/95 | 1/52 | 1/46 |
| NauseaGastrointestinal disorders | 5/102 | 1/95 | 2/52 | 1/46 |
| DizzinessNervous system disorders | 5/102 | 0/95 | 1/52 | 0/46 |
| Skin abrasionInjury, poisoning and procedural complications | 2/102 | 0/95 | 0/52 | 2/46 |
| FatigueGeneral disorders | 3/102 | 0/95 | 2/52 | 1/46 |
| Covid-19Infections and infestations | 1/102 | 0/95 | 2/52 | 0/46 |
| CellulitisInfections and infestations | 0/102 | 3/95 | 0/52 | 0/46 |
| ContusionInjury, poisoning and procedural complications | 3/102 | 0/95 | 1/52 | 0/46 |
| Urinary tract infectionInfections and infestations | 2/102 | 2/95 | 1/52 | 1/46 |
All enrolled participants.
| Age, Categorical(Participants) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 54 | 26 | 80 |
| >=65 years | 49 | 26 | 75 |
| Age, Continuous(years) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| Mean | 63.8 ± 8.3 | 63.6 ± 8.1 | 63.7 ± 8.2 |
| Sex: Female, Male(Participants) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| Female | 42 | 27 | 69 |
| Male | 61 | 25 | 86 |
| Race (NIH/OMB)(Participants) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 8 | 6 | 14 |
| White | 90 | 42 | 132 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| Puerto Rico | 2 | 0 | 2 |
| United States | 101 | 52 | 153 |
| Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)(score on a scale) | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|
| Mean | 5.80 ± 1.87 | 5.99 ± 1.68 | 5.87 ± 1.80 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
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