Trial Outcomes & Findings for Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain (NCT NCT04874636)

Last Updated: 2023-11-02

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

153 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2023-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	600 Milligram (mg) LY3556050 Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.	Placebo Participants received placebo BID every 12 hours for up to 8 weeks.
Overall Study STARTED	102	51
Overall Study Received at Least One Dose of Study Drug	102	50
Overall Study COMPLETED	75	39
Overall Study NOT COMPLETED	27	12

Reasons for withdrawal

Reasons for withdrawal
Measure	600 Milligram (mg) LY3556050 Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.	Placebo Participants received placebo BID every 12 hours for up to 8 weeks.
Overall Study Adverse Event	17	7
Overall Study Lost to Follow-up	1	0
Overall Study Non-Compliance with Study Drug	2	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	6	5

Baseline Characteristics

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	600 mg LY3556050 n=102 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=51 Participants Participants received placebo BID every 12 hours for up to 8 weeks.	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	45 Participants n=7 Participants	126 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	6 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 14.0 • n=5 Participants	52.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	52.5 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	27 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	24 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	39 Participants n=7 Participants	122 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	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	36 Participants n=7 Participants	110 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	102 Participants n=5 Participants	51 Participants n=7 Participants	153 Participants n=5 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	5.73 score on a scale STANDARD_DEVIATION 1.65 • n=5 Participants	5.63 score on a scale STANDARD_DEVIATION 1.55 • n=7 Participants	5.69 score on a scale STANDARD_DEVIATION 1.61 • 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	600 mg LY3556050 n=74 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=38 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-1.69 score on a scale Interval -2.09 to -1.29	-1.77 score on a scale Interval -2.31 to -1.22

SECONDARY outcome

Timeframe: Baseline, 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	600 mg LY3556050 n=76 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=39 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)	-1.71 score on a scale Interval -2.6 to -0.82	-1.92 score on a scale Interval -2.9 to -0.93

SECONDARY outcome

Timeframe: Baseline, Week 8

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 where, 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	600 mg LY3556050 n=76 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=39 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	2.83 score on a scale Interval 2.59 to 3.07	2.69 score on a scale Interval 2.36 to 3.02

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	600 mg LY3556050 n=74 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=38 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.70 score on a scale Interval -2.13 to -1.28	-2.00 score on a scale Interval -2.59 to -1.41

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	600 mg LY3556050 n=76 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=39 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-17.25 score on a scale Interval -22.12 to -12.31	-25.15 score on a scale Interval -31.9 to -18.4

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	600 mg LY3556050 n=76 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=39 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	0.17 hours per night Interval -0.11 to 0.45	0.34 hours per night Interval -0.05 to 0.73

SECONDARY outcome

Timeframe: Week 8

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.

Outcome measures

Outcome measures
Measure	600 mg LY3556050 n=74 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=38 Participants Participants received placebo BID every 12 hours for up to 8 weeks.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	147.24 mg per day (mg/day) Interval 63.77 to 230.12	182.22 mg per day (mg/day) Interval 66.86 to 297.75

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	600 mg LY3556050 n=76 Participants Participants received 600 mg LY3556050 BID every 12 hours for up to 8 weeks.	Placebo n=39 Participants Participants received placebo BID every 12 hours 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)	0.04 score on a scale Interval -0.02 to 0.1	0.04 score on a scale Interval -0.04 to 0.12

Adverse Events

600 mg LY3556050

Serious events: 3 serious events

Other events: 64 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	600 mg LY3556050 n=102 participants at risk Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.	Placebo n=50 participants at risk Participants received placebo BID every 12 hours for up to 8 weeks.
Infections and infestations Coronavirus infection	0.98% 1/102 • 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.	0.00% 0/50 • 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 pneumonia	0.00% 0/102 • 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.	2.0% 1/50 • 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 Diverticulitis	0.98% 1/102 • 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% 0/50 • 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 Anxiety	0.98% 1/102 • 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% 0/50 • 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 Depression	0.98% 1/102 • 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% 0/50 • 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

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

Measure	600 mg LY3556050 n=102 participants at risk Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.	Placebo n=50 participants at risk Participants received placebo BID every 12 hours for up to 8 weeks.
Gastrointestinal disorders Abdominal discomfort	2.0% 2/102 • 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.	4.0% 2/50 • 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.
Gastrointestinal disorders Abdominal distension	0.00% 0/102 • 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.	6.0% 3/50 • 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.
Gastrointestinal disorders Abdominal pain	5.9% 6/102 • 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.	2.0% 1/50 • 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 Constipation	21.6% 22/102 • Number of events 23 • 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.	8.0% 4/50 • 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.
Gastrointestinal disorders Diarrhoea	6.9% 7/102 • Number of events 7 • 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.	4.0% 2/50 • 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.
Gastrointestinal disorders Nausea	24.5% 25/102 • Number of events 27 • 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.	6.0% 3/50 • 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.
Gastrointestinal disorders Vomiting	6.9% 7/102 • Number of events 9 • 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% 0/50 • 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.
General disorders Fatigue	10.8% 11/102 • Number of events 11 • 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.	2.0% 1/50 • 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.
Investigations Glomerular filtration rate decreased	5.9% 6/102 • 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.	0.00% 0/50 • 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	2.0% 2/102 • 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.	4.0% 2/50 • 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 Muscle spasms	0.00% 0/102 • 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.	4.0% 2/50 • 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	10.8% 11/102 • Number of events 12 • 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.	6.0% 3/50 • 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.
Nervous system disorders Headache	10.8% 11/102 • Number of events 12 • 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% 0/50 • 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 Somnolence	9.8% 10/102 • Number of events 11 • 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.	2.0% 1/50 • 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.
Psychiatric disorders Insomnia	2.0% 2/102 • 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.	4.0% 2/50 • 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 Prostatitis	0.00% 0/42 • 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.	4.2% 1/24 • 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.
Vascular disorders Orthostatic hypotension	0.00% 0/102 • 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.	4.0% 2/50 • 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.