Trial Outcomes & Findings for A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain (NCT NCT05630196)

Last Updated: 2024-08-13

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. The data presented are the posterior mean with a 95% credible interval.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2024-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	45 Milligram (mg) LY3857210 Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.	Placebo Participants received placebo orally once daily for up to 8 weeks.
Overall Study STARTED	91	47
Overall Study Received at Least One Dose of Study Drug	91	46
Overall Study COMPLETED	82	38
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	45 Milligram (mg) LY3857210 Participants received 45 mg 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	2	1
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	2	3
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	45 mg LY3857210 n=91 Participants Participants received 45 mg LY3857210 orally once daily for up to 8 weeks	Placebo n=47 Participants Participants received placebo orally once daily for up to 8 weeks.	Total n=138 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	54.6 years STANDARD_DEVIATION 12.7 • n=7 Participants	55.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	32 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	15 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	13 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	34 Participants n=7 Participants	97 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 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	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	40 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants	47 Participants n=7 Participants	138 Participants n=5 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	5.40 score on a scale STANDARD_DEVIATION 1.80 • n=5 Participants	5.71 score on a scale STANDARD_DEVIATION 1.38 • n=7 Participants	5.51 score on a scale STANDARD_DEVIATION 1.67 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who took at least 1 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 LY3857210 orally once daily for up to 8 weeks.	Placebo n=34 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-1.24 score on a scale Interval -1.59 to -0.89	-1.63 score on a scale Interval -2.14 to -1.13

SECONDARY 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.

The RMDQ is a simple, sensitive, and reliable method to measure disability in patients with back pain that consists of 24 statements relating to the participant's perceptions of back pain and associated disability based on physical ability/activity, sleep/rest, psychosocial, household management, eating, and pain frequency. Participants are asked if they feel the statement is descriptive of their own circumstance on that day. The total score is obtained by counting the number of ''Yes'' responses, ranging from: 0 = no disability to 24 = maximal disability. 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 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 on the Roland Morris Disability Questionnaire (RMDQ)	-2.90 score on a scale Interval -3.91 to -1.89	-4.06 score on a scale Interval -5.44 to -2.68

SECONDARY outcome

Timeframe: 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, 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 LY3857210 orally once daily for up to 8 weeks.	Placebo n=35 Participants Participants received placebo orally once daily for up to 8 weeks.
Mean Overall Improvement as Measured by Patient's Global Impression of Change	3.10 score on a scale Interval 2.84 to 3.36	2.88 score on a scale Interval 2.51 to 3.26

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, 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 LY3857210 orally once daily for up to 8 weeks.	Placebo n=34 Participants Participants received placebo orally once daily for up to 8 weeks.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.37 score on a scale Interval -1.75 to -0.99	-1.89 score on a scale Interval -2.43 to -1.34

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 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 on the Visual Analog Scale (VAS) for Pain	-17.78 score on a scale Interval -22.36 to -13.24	-21.97 score on a scale Interval -28.42 to -15.51

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 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 on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	-0.06 Hours per night Interval -0.31 to 0.2	0.29 Hours per night Interval -0.06 to 0.64

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 LY3857210 orally once daily for up to 8 weeks.	Placebo n=34 Participants Participants received placebo orally once daily for up to 8 weeks.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	203.84 mg per day (mg/day) Interval 118.48 to 289.5	214.94 mg per day (mg/day) Interval 94.69 to 337.25

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 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 on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)	0.05 score on a scale Interval -0.01 to 0.11	0.06 score on a scale Interval -0.02 to 0.15

Adverse Events

45 mg LY3857210

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	45 mg LY3857210 n=91 participants at risk Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.	Placebo n=46 participants at risk Participants received placebo orally once daily for up to 8 weeks.
Gastrointestinal disorders Abdominal pain	1.1% 1/91 • 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% 0/46 • 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.
Hepatobiliary disorders Cholecystitis acute	1.1% 1/91 • 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% 0/46 • 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 Appendicitis	1.1% 1/91 • 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% 0/46 • 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=91 participants at risk Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.	Placebo n=46 participants at risk Participants received placebo orally once daily for up to 8 weeks.
Gastrointestinal disorders Diarrhoea	4.4% 4/91 • 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.	2.2% 1/46 • 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.
Gastrointestinal disorders Nausea	3.3% 3/91 • 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.	6.5% 3/46 • 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.
Infections and infestations Covid-19	4.4% 4/91 • 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.	2.2% 1/46 • 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.
Infections and infestations Upper respiratory tract infection	3.3% 3/91 • 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.	4.3% 2/46 • 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.
Injury, poisoning and procedural complications Muscle strain	3.3% 3/91 • 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.	2.2% 1/46 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 2/91 • 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.	4.3% 2/46 • 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	3.3% 3/91 • 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.	4.3% 2/46 • 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 Headache	5.5% 5/91 • Number of events 6 • 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.	4.3% 2/46 • 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.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/55 • 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.	3.1% 1/32 • 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.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60