Trial Outcomes & Findings for A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05). (NCT NCT05620576)

NCT ID: NCT05620576

Last Updated: 2024-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

131 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2024-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	45 mg LY3857210 Participants received 45 milligram (mg) of LY3857210 orally once daily for up to 8 weeks.	Placebo Participants received placebo orally once daily for up to 8 weeks.
Overall Study STARTED	87	44
Overall Study Received at Least One Dose of Study Drug	87	44
Overall Study COMPLETED	80	37
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	45 mg LY3857210 Participants received 45 milligram (mg) of LY3857210 orally once daily for up to 8 weeks.	Placebo Participants received placebo orally once daily for up to 8 weeks.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	0	1
Overall Study Protocol Deviation	1	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	45 mg LY3857210 n=87 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=44 Participants Participants received placebo orally once daily for up to 8 weeks.	Total n=131 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 8.7 • n=5 Participants	63.7 years STANDARD_DEVIATION 9.4 • n=7 Participants	63.6 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	13 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	31 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	19 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	25 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	38 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	87 Participants n=5 Participants	44 Participants n=7 Participants	131 Participants n=5 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [	5.91 score on a scale STANDARD_DEVIATION 1.58 • n=5 Participants	5.62 score on a scale STANDARD_DEVIATION 1.60 • n=7 Participants	5.81 score on a scale STANDARD_DEVIATION 1.59 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=74 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=35 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-1.70 score on a scale Interval -2.11 to -1.3	-1.81 score on a scale Interval -2.4 to -1.21

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=77 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=36 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	-1.45 score on a scale Interval -1.88 to -1.01	-1.71 score on a scale Interval -2.34 to -1.08

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=78 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=36 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGIC)	2.83 score on a scale Interval 2.58 to 3.08	2.51 score on a scale Interval 2.14 to 2.87

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=74 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=35 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.69 score on a scale Interval -2.12 to -1.25	-1.89 score on a scale Interval -2.52 to -1.25

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=78 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=36 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-25.44 score on a scale Interval -30.5 to -20.39	-24.67 score on a scale Interval -31.96 to -17.32

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=78 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=36 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	0.07 hours per night Interval -0.15 to 0.3	0.21 hours per night Interval -0.11 to 0.53

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=78 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=36 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)	0.06 score on a scale Interval -0.01 to 0.12	0.07 score on a scale Interval -0.02 to 0.15

SECONDARY outcome

Timeframe: Week 8

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.

Outcome measures

Outcome measures
Measure	45 mg LY3857210 n=74 Participants Participants received 45 mg of LY3857210 orally once daily for up to 8 weeks.	Placebo n=35 Participants Participants received placebo orally once daily for up to 8 weeks.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	156.82 milligram per day Interval 81.73 to 231.29	133.80 milligram per day Interval 28.09 to 240.77

Adverse Events

45 mg LY3857210

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	45 mg LY3857210 n=87 participants at risk Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.	Placebo n=44 participants at risk Participants received placebo orally once daily for up to 8 weeks.
Infections and infestations Cellulitis	1.1% 1/87 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	1.1% 1/87 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	1.1% 1/87 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/87 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	45 mg LY3857210 n=87 participants at risk Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.	Placebo n=44 participants at risk Participants received placebo orally once daily for up to 8 weeks.
Nervous system disorders Headache	4.6% 4/87 • Number of events 4 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	3.4% 3/87 • Number of events 3 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Abnormal dreams	0.00% 0/87 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	5.7% 5/87 • Number of events 5 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	3.0% 1/33 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/87 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/87 • Number of events 1 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	2.3% 2/87 • Number of events 2 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 4/87 • Number of events 4 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline through Week 8 All enrolled participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60