Trial Outcomes & Findings for Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis (NCT NCT05080660)

Last Updated: 2024-07-17

Results Overview

The NRS was used during the preliminary data entry period and daily throughout the study 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

160 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2024-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	250 Milligram (mg) LY3526318 Participants received 250 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.	Placebo Participants received placebo orally, once daily, for 8-weeks treatment period.
Overall Study STARTED	107	53
Overall Study Received at Least One Dose of Study Drug (Safety Population Week 1-4)	107	53
Overall Study Safety Population Week 5-8	99	51
Overall Study COMPLETED	94	51
Overall Study NOT COMPLETED	13	2

Reasons for withdrawal

Reasons for withdrawal
Measure	250 Milligram (mg) LY3526318 Participants received 250 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.	Placebo Participants received placebo orally, once daily, for 8-weeks treatment period.
Overall Study Adverse Event	4	0
Overall Study Non-compliance With Study Drug and Procedures	1	0
Overall Study Physician Decision	1	0
Overall Study Protocol Deviation	2	0
Overall Study Withdrawal by Subject	5	2

Baseline Characteristics

Participants with non-missing baseline NRS data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	250 mg LY3526318 n=107 Participants Participants received 250 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.	Placebo n=53 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=107 Participants	0 Participants n=53 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=107 Participants	31 Participants n=53 Participants	85 Participants n=160 Participants
Age, Categorical >=65 years	53 Participants n=107 Participants	22 Participants n=53 Participants	75 Participants n=160 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 8.3 • n=107 Participants	62.7 years STANDARD_DEVIATION 9.3 • n=53 Participants	63.5 years STANDARD_DEVIATION 8.6 • n=160 Participants
Sex: Female, Male Female	68 Participants n=107 Participants	33 Participants n=53 Participants	101 Participants n=160 Participants
Sex: Female, Male Male	39 Participants n=107 Participants	20 Participants n=53 Participants	59 Participants n=160 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=107 Participants	12 Participants n=53 Participants	42 Participants n=160 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=107 Participants	40 Participants n=53 Participants	117 Participants n=160 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=107 Participants	1 Participants n=53 Participants	1 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=107 Participants	1 Participants n=53 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=107 Participants	2 Participants n=53 Participants	2 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=107 Participants	0 Participants n=53 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	13 Participants n=107 Participants	11 Participants n=53 Participants	24 Participants n=160 Participants
Race (NIH/OMB) White	88 Participants n=107 Participants	38 Participants n=53 Participants	126 Participants n=160 Participants
Race (NIH/OMB) More than one race	2 Participants n=107 Participants	0 Participants n=53 Participants	2 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=107 Participants	1 Participants n=53 Participants	5 Participants n=160 Participants
Region of Enrollment United States	107 Participants n=107 Participants	53 Participants n=53 Participants	160 Participants n=160 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	5.52 score on a scale STANDARD_DEVIATION 1.60 • n=106 Participants • Participants with non-missing baseline NRS data.	5.91 score on a scale STANDARD_DEVIATION 1.25 • n=53 Participants • Participants with non-missing baseline NRS data.	5.65 score on a scale STANDARD_DEVIATION 1.50 • n=159 Participants • Participants with non-missing baseline NRS data.

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes number of participants with non-missing values at Week 4.

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=97 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-0.95 score on a scale Interval -1.24 to -0.67	-1.18 score on a scale Interval -1.58 to -0.78

SECONDARY outcome

Timeframe: Baseline, Week 8

The NRS was used during the preliminary data entry period and daily throughout the study 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 interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=90 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-1.26 score on a scale Interval -1.6 to -0.93	-1.45 score on a scale Interval -1.92 to -0.99

SECONDARY outcome

Timeframe: Baseline, Week 4

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 4.

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 questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. 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	250 mg LY3526318 n=107 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale	-1.87 score on a scale Interval -2.4 to -1.36	-2.50 score on a scale Interval -3.21 to -1.79

SECONDARY outcome

Timeframe: Baseline, 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 questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. 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	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale	-2.51 score on a scale Interval -3.15 to -1.87	-2.85 score on a scale Interval -3.69 to -1.99

SECONDARY outcome

Timeframe: Baseline, Week 4

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 each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale. 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	250 mg LY3526318 n=100 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the WOMAC® Stiffness Subscale	-1.04 score on a scale Interval -1.32 to -0.76	-1.11 score on a scale Interval -1.48 to -0.75

SECONDARY outcome

Timeframe: Baseline, 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 each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale. 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	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the WOMAC® Stiffness Subscale	-1.16 score on a scale Interval -1.46 to -0.86	-1.26 score on a scale Interval -1.65 to -0.87

SECONDARY outcome

Timeframe: Baseline, Week 4

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 scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 68 for the physical function subscale. 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	250 mg LY3526318 n=99 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the WOMAC® Physical Function Subscale	-6.48 score on a scale Interval -8.21 to -4.76	-8.46 score on a scale Interval -10.86 to -6.1

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=95 Participants Participants received 250 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.	Placebo n=50 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the WOMAC® Physical Function Subscale	-8.04 score on a scale Interval -10.07 to -6.01	-11.09 score on a scale Interval -13.82 to -8.33

SECONDARY outcome

Timeframe: Baseline, Week 4

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.

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=100 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change	3.18 score on a scale Interval 2.97 to 3.4	3.05 score on a scale Interval 2.75 to 3.35

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change	2.96 score on a scale Interval 2.74 to 3.18	2.97 score on a scale Interval 2.66 to 3.28

SECONDARY outcome

Timeframe: Baseline, Week 4

The NRS was used during the preliminary data entry period and daily throughout the study 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	250 mg LY3526318 n=97 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.08 score on a scale Interval -1.38 to -0.79	-1.38 score on a scale Interval -1.79 to -0.97

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=90 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.41 score on a scale Interval -1.76 to -1.05	-1.70 score on a scale Interval -2.19 to -1.21

SECONDARY outcome

Timeframe: Baseline, Week 4

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	250 mg LY3526318 n=100 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-11.69 score on a scale Interval -15.47 to -7.87	-17.82 score on a scale Interval -23.08 to -12.61

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-16.41 score on a scale Interval -20.55 to -12.32	-21.55 score on a scale Interval -27.3 to -15.81

SECONDARY outcome

Timeframe: Baseline, Week 4

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	250 mg LY3526318 n=100 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	0.04 Hours per night Interval -0.14 to 0.22	0.06 Hours per night Interval -0.18 to 0.31

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=50 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	-0.01 Hours per night Interval -0.21 to 0.19	0.19 Hours per night Interval -0.08 to 0.45

SECONDARY outcome

Timeframe: Week 4

Total amount of rescue medication use as measured by average daily dosage. 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	250 mg LY3526318 n=97 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	271.27 mg per day (mg/day) Interval 182.84 to 359.36	172.92 mg per day (mg/day) Interval 47.39 to 296.22

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=90 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	284.83 mg/day Interval 185.06 to 385.02	161.47 mg/day Interval 22.36 to 299.42

SECONDARY outcome

Timeframe: Baseline, Week 4

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. 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	250 mg LY3526318 n=100 Participants Participants received 250 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.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)	0.04 score on a scale Interval 0.0 to 0.08	0.05 score on a scale Interval -0.01 to 0.1

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=96 Participants Participants received 250 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.	Placebo n=51 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)	0.05 score on a scale Interval 0.0 to 0.1	0.05 score on a scale Interval -0.01 to 0.12

Adverse Events

250 mg LY3526318 (Week 1 to 4)

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

250 mg LY3526318/Placebo (Week 5 to 8)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo (Week 1 to 4)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo (Week 5 to 8)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	250 mg LY3526318 (Week 1 to 4) n=107 participants at risk Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period (Week 1-4).	250 mg LY3526318/Placebo (Week 5 to 8) n=99 participants at risk Participants who received 250 mg of LY3526318 in the first 4 weeks were switched to received placebo once daily for the next 4 weeks of the treatment period (Week 5-8).	Placebo (Week 1 to 4) n=53 participants at risk Participants received placebo orally, once daily, for week 1 to 4 of treatment period.	Placebo (Week 5 to 8) n=51 participants at risk Participants received placebo orally, once daily, for week 5 to 8 of treatment period.
Cardiac disorders Atrial fibrillation	0.00% 0/107 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/99 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	1.9% 1/53 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/51 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Eye disorders Diplopia	0.93% 1/107 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/99 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/53 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/51 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Nervous system disorders Dizziness	0.93% 1/107 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/99 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/53 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/51 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Nervous system disorders Dysarthria	0.93% 1/107 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/99 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/53 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/51 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.

Other adverse events

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