Trial Outcomes & Findings for Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain (NCT NCT05177094)

Last Updated: 2023-11-22

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 intervals 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

155 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2023-11-22

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	103	52
Overall Study Received at Least One Dose of Study Drug (Safety Population Week 1-4)	102	52
Overall Study Safety Population Week 5-8	95	46
Overall Study COMPLETED	88	43
Overall Study NOT COMPLETED	15	9

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	5	5
Overall Study Non-compliance With Study Drug and Procedures	0	1
Overall Study Protocol Deviation	3	0
Overall Study Withdrawal by Subject	6	3
Overall Study Participant could not tolerate long study visits	1	0

Baseline Characteristics

Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	250 mg LY3526318 n=103 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 n=155 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	54 Participants n=5 Participants	26 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	26 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	63.8 years STANDARD_DEVIATION 8.3 • n=5 Participants	63.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	63.7 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	27 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	25 Participants n=7 Participants	86 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	42 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Puerto Rico	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	101 Participants n=5 Participants	52 Participants n=7 Participants	153 Participants n=5 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	5.80 score on a scale STANDARD_DEVIATION 1.87 • n=5 Participants	5.99 score on a scale STANDARD_DEVIATION 1.68 • n=7 Participants	5.87 score on a scale STANDARD_DEVIATION 1.80 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

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 4.

Outcome measures

Outcome measures
Measure	250 mg LY3526318 n=94 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=46 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)	-1.50 score on a scale Interval -1.81 to -1.19	-1.35 score on a scale Interval -1.8 to -0.9

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.

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% 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=85 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=38 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)	-1.80 score on a scale Interval -2.17 to -1.42	-1.78 score on a scale Interval -2.32 to -1.24

SECONDARY outcome

Timeframe: Baseline, Week 4

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 4.

The BPI-SFM is a numeric rating scale that assesses the severity of pain (severity scale) and its impact on daily functioning (Pain Interference scale). BPI-SFM pain interference scale has been reported here. Pain interference scale has 7 items, including general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life each assessed on a 10-point scale. All the 7-items are averaged to produce a total score ranging from 0 to 10 where, 0=does not interfere to 10=completely interferes and the mean is reported here. Higher score represents worse outcome. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Outcome measures
Measure	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=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	-1.54 score on a scale Interval -1.9 to -1.17	-1.41 score on a scale Interval -1.9 to -0.91

SECONDARY 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	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=44 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score	-1.69 score on a scale Interval -2.14 to -1.25	-1.43 score on a scale Interval -2.05 to -0.81

SECONDARY outcome

Timeframe: Baseline, Week 4

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 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=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=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	2.77 score on a scale Interval 2.55 to 3.0	2.99 score on a scale Interval 2.67 to 3.31

SECONDARY 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	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=44 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	2.77 score on a scale Interval 2.54 to 3.01	2.94 score on a scale Interval 2.61 to 3.28

SECONDARY outcome

Timeframe: Baseline, Week 4

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 4.

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	250 mg LY3526318 n=94 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=46 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.48 score on a scale Interval -1.81 to -1.15	-1.36 score on a scale Interval -1.83 to -0.88

SECONDARY 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	250 mg LY3526318 n=85 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=38 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.68 score on a scale Interval -2.09 to -1.26	-1.74 score on a scale Interval -2.32 to -1.14

SECONDARY outcome

Timeframe: Baseline, Week 4

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 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=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=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-21.84 score on a scale Interval -26.33 to -17.38	-18.75 score on a scale Interval -24.99 to -12.55

SECONDARY 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	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=44 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-23.11 score on a scale Interval -28.31 to -17.95	-21.61 score on a scale Interval -28.74 to -14.5

SECONDARY outcome

Timeframe: Baseline, Week 4

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 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=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=47 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	0.40 hours per night Interval 0.14 to 0.66	0.29 hours per night Interval -0.07 to 0.65

SECONDARY 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	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=44 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	0.45 hours per night Interval 0.17 to 0.74	0.25 hours per night Interval -0.13 to 0.63

SECONDARY outcome

Timeframe: Week 4

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 4.

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	250 mg LY3526318 n=94 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=46 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	255.71 mg per day (mg/day) Interval 163.5 to 347.62	211.35 mg per day (mg/day) Interval 81.1 to 342.14

SECONDARY outcome

Timeframe: 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	250 mg LY3526318 n=85 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=38 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	138.75 mg/day Interval 62.87 to 215.62	237.51 mg/day Interval 126.82 to 346.84

SECONDARY outcome

Timeframe: Baseline, Week 4

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 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 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	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=47 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) Health State Index (United States Algorithm)	0.04 score on a scale Interval 0.0 to 0.08	0.03 score on a scale Interval -0.02 to 0.09

SECONDARY 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	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=44 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) Health State Index (United States Algorithm)	0.05 score on a scale Interval -0.01 to 0.1	0.05 score on a scale Interval -0.02 to 0.13

Adverse Events

250 mg LY3526318 Week 1-4

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

250 mg LY3526318/Placebo Week 5-8

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo Week 1-4

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo Week 5-8

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	250 mg LY3526318 Week 1-4 n=102 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 5-8 n=95 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 1-4 n=52 participants at risk Participants received placebo orally, once daily, for week 1 to 4 of treatment period.	Placebo Week 5-8 n=46 participants at risk Participant from Week 1-4 continued to receive placebo orally, once daily, for week 5 to 8 of treatment period.
Cardiac disorders Acute myocardial infarction	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	1.9% 1/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
General disorders Chest pain	0.98% 1/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Infections and infestations Cellulitis	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	2.1% 2/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Injury, poisoning and procedural complications Contusion	0.98% 1/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	2.2% 1/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	2.2% 1/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	2.2% 1/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	1.1% 1/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.
Nervous system disorders Transient ischaemic attack	0.98% 1/102 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/95 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/52 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8.	0.00% 0/46 • 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: 8005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60