Trial Outcomes & Findings for A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (NCT NCT05620563)
NCT ID: NCT05620563
Last Updated: 2024-06-26
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.
COMPLETED
PHASE2
147 participants
Baseline, Week 8
2024-06-26
Participant Flow
Participant milestones
| Measure |
45 mg LY3857210
Participants received 45 milligram (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
|
98
|
49
|
|
Overall Study
Received at Least One Dose of Study Drug
|
98
|
48
|
|
Overall Study
COMPLETED
|
91
|
40
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
45 mg LY3857210
Participants received 45 milligram (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
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
All enrolled participants with non-missing baseline NRS data.
Baseline characteristics by cohort
| Measure |
45 mg LY3857210
n=98 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=49 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.2 • n=98 Participants
|
61.8 years
STANDARD_DEVIATION 8.0 • n=49 Participants
|
62.5 years
STANDARD_DEVIATION 8.8 • n=147 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=98 Participants
|
29 Participants
n=49 Participants
|
87 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=98 Participants
|
20 Participants
n=49 Participants
|
60 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=98 Participants
|
14 Participants
n=49 Participants
|
32 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=98 Participants
|
35 Participants
n=49 Participants
|
115 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=98 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=98 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=98 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=98 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=98 Participants
|
3 Participants
n=49 Participants
|
15 Participants
n=147 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=98 Participants
|
45 Participants
n=49 Participants
|
128 Participants
n=147 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=98 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=98 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=147 Participants
|
|
Region of Enrollment
United States
|
98 Participants
n=98 Participants
|
49 Participants
n=49 Participants
|
147 Participants
n=147 Participants
|
|
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
|
5.62 score on a scale
STANDARD_DEVIATION 1.61 • n=97 Participants • All enrolled participants with non-missing baseline NRS data.
|
5.58 score on a scale
STANDARD_DEVIATION 1.80 • n=49 Participants • All enrolled participants with non-missing baseline NRS data.
|
5.60 score on a scale
STANDARD_DEVIATION 1.67 • n=146 Participants • All enrolled participants with non-missing baseline NRS data.
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
45 mg LY3857210
n=85 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=40 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)
|
-1.13 score on a scale
Interval -1.47 to -0.8
|
-1.43 score on a scale
Interval -1.9 to -0.96
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 5 questions on the pain subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no pain, and 4 = extreme pain. The scores for the pain subscale were calculated by summing the scores of the 5 questions for each participant at each time point. The range of possible scores is 0 to 20 with higher scores representing 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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale
|
-2.44 score on a scale
Interval -3.05 to -1.84
|
-2.29 score on a scale
Interval -3.14 to -1.44
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 2 questions in the stiffness subscale and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no stiffness, and 4 = extreme stiffness. The scores for the stiffness subscale was calculated by summing the scores of the 2 questions for each participant at each time point. The range of possible scores is 0 to 8 with higher scores representing 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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the WOMAC® Stiffness Subscale
|
-1.32 score on a scale
Interval -1.66 to -0.99
|
-0.85 score on a scale
Interval -1.3 to -0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 17 questions in the physical function subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no difficulty, and 4 = extreme difficulty. The score for physical function subscale was calculated by summing the scores of the 17 questions for each participant at each time point. The range of possible scores is 0 to 68 with higher scores representing 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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the WOMAC® Physical Function Subscale
|
-8.62 score on a scale
Interval -10.57 to -6.66
|
-8.07 score on a scale
Interval -10.82 to -5.3
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 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
|
3.07 score on a scale
Interval 2.83 to 3.31
|
2.99 score on a scale
Interval 2.64 to 3.33
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 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
| Measure |
45 mg LY3857210
n=85 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=40 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline for Worst Pain Intensity as Measured by NRS
|
-1.25 score on a scale
Interval -1.63 to -0.87
|
-1.54 score on a scale
Interval -2.08 to -1.01
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline on the Visual Analog Scale (VAS) for Pain
|
-16.02 score on a scale
Interval -20.52 to -11.5
|
-18.21 score on a scale
Interval -24.67 to -11.76
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 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
|
-0.03 Hours per night
Interval -0.22 to 0.17
|
0.05 Hours per night
Interval -0.22 to 0.31
|
SECONDARY outcome
Timeframe: Week 8Population: 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.
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
| Measure |
45 mg LY3857210
n=85 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=40 Participants
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
|
198.16 milligram per day
Interval 117.57 to 279.38
|
174.01 milligram per day
Interval 58.91 to 288.64
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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 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
| Measure |
45 mg LY3857210
n=88 Participants
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=41 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 0.1
|
0.06 score on a scale
Interval -0.02 to 0.13
|
Adverse Events
45 mg LY3857210
Placebo
Serious adverse events
| Measure |
45 mg LY3857210
n=98 participants at risk
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=48 participants at risk
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Infections and infestations
Tooth abscess
|
0.00%
0/98 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
2.1%
1/48 • Number of events 1 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
45 mg LY3857210
n=98 participants at risk
Participants received 45 mg LY3857210 orally once daily for up to 8 weeks.
|
Placebo
n=48 participants at risk
Participants received placebo orally once daily for up to 8 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
4/98 • Number of events 4 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/48 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/98 • Number of events 3 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/48 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.0%
2/98 • Number of events 2 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
6.2%
3/48 • Number of events 3 • Baseline through Week 8
All enrolled participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60