Trial Outcomes & Findings for A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease (NCT NCT05063539)

Last Updated: 2025-07-28

Results Overview

iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

327 participants

Primary outcome timeframe

Baseline, Week 100

Results posted on

2025-07-28

Participant Flow

Current results reporting is only for the primary outcome data per Primary Database Lock (July 9, 2024) and final results will be presented at the time of reporting the final results, i.e., no later than May 22, 2026.

Participant milestones

Participant milestones
Measure	0.75 Milligrams (mg) LY3372689 Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo Participants received placebo administered orally once daily for up to 124 weeks.
Overall Study STARTED	110	109	108
Overall Study Received at Least 1 Dose of Study Drug (Safety Population)	108	110	108
Overall Study COMPLETED	86	70	89
Overall Study NOT COMPLETED	24	39	19

Reasons for withdrawal

Reasons for withdrawal
Measure	0.75 Milligrams (mg) LY3372689 Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo Participants received placebo administered orally once daily for up to 124 weeks.
Overall Study Adverse Event	1	2	1
Overall Study Death	0	1	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Physician Decision	4	3	1
Overall Study Progressive Disease	0	2	0
Overall Study Withdrawal by Subject	17	26	14
Overall Study Withdrawal Due To Caregiver Circumstances	1	1	0
Overall Study Subject was Randomized in IWRS prior to Realization that Vital signs would be Exclusionary	1	0	0
Overall Study Subject no longer Wished to Continue with IP or Follow-up Visits	0	0	1
Overall Study Discontinued due to Common Close Design	0	1	0
Overall Study Participant not co-operative	0	1	0
Overall Study Patient Moving to Different Place from Where it takes 4 hours to Come to Site to Continue	0	0	1
Overall Study Caregiver Withdrew Consent due to Participant Moved to Long Term Care Home	0	1	0

Baseline Characteristics

A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.75 mg LY3372689 n=110 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=109 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=108 Participants Participants received placebo administered orally once daily for up to 124 weeks.	Total n=327 Participants Total of all reporting groups
Age, Continuous	73.3 years STANDARD_DEVIATION 5.40 • n=5 Participants	73.4 years STANDARD_DEVIATION 5.38 • n=7 Participants	73.4 years STANDARD_DEVIATION 5.47 • n=5 Participants	73.4 years STANDARD_DEVIATION 5.40 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	63 Participants n=7 Participants	68 Participants n=5 Participants	201 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	46 Participants n=7 Participants	40 Participants n=5 Participants	126 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants	102 Participants n=7 Participants	102 Participants n=5 Participants	308 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	94 Participants n=7 Participants	94 Participants n=5 Participants	283 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Australia	14 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment Canada	12 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Region of Enrollment Japan	11 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	35 Participants n=4 Participants
Region of Enrollment Poland	16 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	55 Participants n=4 Participants
Region of Enrollment United States	57 Participants n=5 Participants	55 Participants n=7 Participants	59 Participants n=5 Participants	171 Participants n=4 Participants
Baseline Integrated Alzheimer's Disease Rating Scale (iADRS) Score	111.8 Score on a scale STANDARD_DEVIATION 11.99 • n=5 Participants	109.3 Score on a scale STANDARD_DEVIATION 13.25 • n=7 Participants	110.4 Score on a scale STANDARD_DEVIATION 12.77 • n=5 Participants	110.5 Score on a scale STANDARD_DEVIATION 12.68 • n=4 Participants
Screening Tau Category Intermediate (Low-medium)	87 Participants n=5 Participants	86 Participants n=7 Participants	86 Participants n=5 Participants	259 Participants n=4 Participants
Screening Tau Category High	23 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	68 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 100

Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=86 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=85 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=84 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)	-8.39 score on a scale Interval -10.219 to -6.64	-13.27 score on a scale Interval -15.481 to -11.097	-10.07 score on a scale Interval -11.9 to -8.338

SECONDARY outcome

Timeframe: Baseline, Week 100

Population: All randomized participants with baseline or post-baseline data for this outcome.

iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, baseline tau PET category, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=109 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=108 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=106 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in iADRS (Overall Population)	-10.48 score on a scale Interval -12.247 to -8.739	-17.14 score on a scale Interval -19.379 to -14.9	-12.07 score on a scale Interval -13.916 to -10.37

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.

CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score are assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=84 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=80 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=84 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)	0.91 score on a scale Standard Error 0.23	2.14 score on a scale Standard Error 0.24	1.05 score on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome.

CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, baseline tau PET category, AChEI/Memantine use at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=106 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=101 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=106 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population)	1.54 score on a scale Standard Error 0.25	2.81 score on a scale Standard Error 0.27	1.48 score on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.

The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviours characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=84 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=80 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=84 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)	4.00 score on a scale Standard Error 0.70	4.91 score on a scale Standard Error 0.76	5.14 score on a scale Standard Error 0.69

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=106 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=102 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=106 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)	5.58 score on a scale Standard Error 0.78	7.61 score on a scale Standard Error 0.83	5.95 score on a scale Standard Error 0.76

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.

The ADCS-iADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-iADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=83 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=79 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=82 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Intermediate (Low-medium) Tau Population)	-2.65 score on a scale Standard Error 0.72	-5.34 score on a scale Standard Error 0.77	-2.82 score on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=105 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=101 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=104 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Overall Population)	-4.02 score on a scale Standard Error 0.79	-7.26 score on a scale Standard Error 0.83	-3.24 score on a scale Standard Error 0.77

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.

MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=84 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=80 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=84 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Intermediate (Low-medium) Tau Population)	-1.65 score on a scale Standard Error 0.38	-2.79 score on a scale Standard Error 0.41	-2.25 score on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline or post-baseline data for this outcome.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=106 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=102 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=106 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Overall Population)	-2.52 score on a scale Standard Error 0.41	-4.00 score on a scale Standard Error 0.44	-2.70 score on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline PET tau data.

Flortaucipir PET imaging was used as a quantitative tau biomarker. Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) from the following composite brain regions: frontal, parietal, occipital, and temporal lobes and the Alzheimer's disease (AD) neocortical signature. The AD neocortical signature region of interest refers to a weighted Alzheimer's Disease specific neocortical region derived from Multiblock Barycentric Discriminant Analysis. Cerebellar gray matter was used as a reference region to derive an SUVr. Larger SUVR reflects larger tau burden. LS Mean change from baseline was calculated using ANCOVA adjusted for baseline score, age and treatment (Type III sum of squares).

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=68 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=57 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=70 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) Frontal	0.05 standardized uptake value ratio (SUVR) Standard Error 0.008	0.03 standardized uptake value ratio (SUVR) Standard Error 0.009	0.04 standardized uptake value ratio (SUVR) Standard Error 0.008
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) Parietal	0.05 standardized uptake value ratio (SUVR) Standard Error 0.009	0.03 standardized uptake value ratio (SUVR) Standard Error 0.010	0.06 standardized uptake value ratio (SUVR) Standard Error 0.009
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) Lateral occipital	0.04 standardized uptake value ratio (SUVR) Standard Error 0.015	0.05 standardized uptake value ratio (SUVR) Standard Error 0.016	0.07 standardized uptake value ratio (SUVR) Standard Error 0.015
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) Lateral temporal	0.07 standardized uptake value ratio (SUVR) Standard Error 0.011	0.04 standardized uptake value ratio (SUVR) Standard Error 0.012	0.07 standardized uptake value ratio (SUVR) Standard Error 0.011
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) AD neocortical signature (measured using MUBADA)	0.07 standardized uptake value ratio (SUVR) Standard Error 0.011	0.05 standardized uptake value ratio (SUVR) Standard Error 0.012	0.08 standardized uptake value ratio (SUVR) Standard Error 0.010

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline and post-baseline PET tau data.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=79 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=70 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=86 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) Frontal	0.07 SUVR Standard Error 0.011	0.06 SUVR Standard Error 0.011	0.06 SUVR Standard Error 0.011
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) Parietal	0.08 SUVR Standard Error 0.013	0.08 SUVR Standard Error 0.013	0.07 SUVR Standard Error 0.012
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) Lateral occipital	0.08 SUVR Standard Error 0.018	0.09 SUVR Standard Error 0.018	0.09 SUVR Standard Error 0.017
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) Lateral temporal	0.08 SUVR Standard Error 0.015	0.07 SUVR Standard Error 0.015	0.08 SUVR Standard Error 0.014
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) AD neocortical signature (measured using MUBADA)	0.09 SUVR Standard Error 0.014	0.08 SUVR Standard Error 0.015	0.09 SUVR Standard Error 0.014

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline vMRI data.

MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in brain regions: bilateral hippocampus, bilateral whole lateral ventricles, and bilateral whole brain. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean change from baseline was determined by mixed model repeated measures (MMRM) model with fixed effects of treatment, visit, treatment-by-visit interaction, and adjusted for baseline volume, age at baseline.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=68 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=61 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=75 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population) Bilateral Hippocampus	-0.19 cubic centimeter (cm^3) Standard Error 0.017	-0.16 cubic centimeter (cm^3) Standard Error 0.019	-0.28 cubic centimeter (cm^3) Standard Error 0.016
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population) Bilateral Whole Lateral Ventricles	3.52 cubic centimeter (cm^3) Standard Error 0.425	4.25 cubic centimeter (cm^3) Standard Error 0.458	5.89 cubic centimeter (cm^3) Standard Error 0.405
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population) Bilateral Whole Brain	-10.75 cubic centimeter (cm^3) Standard Error 1.231	-9.56 cubic centimeter (cm^3) Standard Error 1.345	-18.92 cubic centimeter (cm^3) Standard Error 1.186

SECONDARY outcome

Timeframe: Baseline, Week 76

Population: All randomized participants with baseline and at least one postbaseline vMRI data.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=82 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=78 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=94 Participants Participants received placebo administered orally once daily for up to 124 weeks.
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population) Bilateral Hippocampus	-0.21 cm^3 Standard Error 0.018	-0.17 cm^3 Standard Error 0.018	-0.29 cm^3 Standard Error 0.017
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population) Bilateral Whole Lateral Ventricles	4.95 cm^3 Standard Error 0.444	5.74 cm^3 Standard Error 0.455	7.16 cm^3 Standard Error 0.409
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population) Bilateral Whole Brain	-15.61 cm^3 Standard Error 1.292	-14.62 cm^3 Standard Error 1.313	-22.78 cm^3 Standard Error 1.195

SECONDARY outcome

Timeframe: Week 64: Post-dose

Population: All randomized participants who received at least one 1 of study drug and had evaluable C-trough data at the specified time points

Blood samples were measured at week 64 to assess the concentration of LY3372689 in the plasma.

Outcome measures

Outcome measures
Measure	0.75 mg LY3372689 n=76 Participants Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=69 Participants Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo Participants received placebo administered orally once daily for up to 124 weeks.
Pharmacokinetics (PK): Plasma Concentrations of LY3372689	3.95 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 163	12.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 212	—

Adverse Events

0.75mg LY3372689

Serious events: 13 serious events

Other events: 74 other events

Deaths: 0 deaths

3 mg LY3372689

Serious events: 29 serious events

Other events: 72 other events

Deaths: 2 deaths

Placebo

Serious events: 17 serious events

Other events: 81 other events

Deaths: 1 deaths

Serious adverse events

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

Restriction type: GT60

Serious adverse events
Measure	0.75mg LY3372689 n=108 participants at risk Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=110 participants at risk Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=108 participants at risk Participants received placebo administered orally once daily for up to 124 weeks.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Cardiac disorders Atrial fibrillation	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	2.7% 3/110 • Number of events 3 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Cardiac disorders Atrioventricular block complete	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Cardiac disorders Palpitations	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Cardiac disorders Stress cardiomyopathy	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Ear and labyrinth disorders Vertigo	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Diarrhoea	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Gastric ulcer	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Inguinal hernia	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
General disorders Chest pain	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
General disorders Non-cardiac chest pain	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Appendicitis	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Cellulitis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Covid-19	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Covid-19 pneumonia	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Dental sepsis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Encephalitis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Gastrointestinal fungal infection	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Perirectal abscess	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Pneumonia	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Urinary tract infection	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Urosepsis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Concussion	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Fall	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.8% 2/110 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Pelvic fracture	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Postoperative delirium	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Spinal compression fracture	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Metabolism and nutrition disorders Dehydration	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/110 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.91% 1/110 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/108 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.

Other adverse events
Measure	0.75mg LY3372689 n=108 participants at risk Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.	3 mg LY3372689 n=110 participants at risk Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.	Placebo n=108 participants at risk Participants received placebo administered orally once daily for up to 124 weeks.
Blood and lymphatic system disorders Anaemia	2.8% 3/108 • Number of events 3 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.5% 6/110 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Diarrhoea	12.0% 13/108 • Number of events 18 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	10.9% 12/110 • Number of events 17 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	11.1% 12/108 • Number of events 14 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.6% 6/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.8% 2/110 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.93% 1/108 • Number of events 1 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Gastrointestinal disorders Nausea	6.5% 7/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 11 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	6.5% 7/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
General disorders Fatigue	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.5% 6/110 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.6% 5/108 • Number of events 5 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Covid-19	22.2% 24/108 • Number of events 27 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	15.5% 17/110 • Number of events 18 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	21.3% 23/108 • Number of events 24 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Nasopharyngitis	4.6% 5/108 • Number of events 5 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	6.4% 7/110 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	8.3% 9/108 • Number of events 10 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Upper respiratory tract infection	13.0% 14/108 • Number of events 17 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	10.0% 11/110 • Number of events 13 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.4% 8/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Infections and infestations Urinary tract infection	7.4% 8/108 • Number of events 11 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 13 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	12.0% 13/108 • Number of events 21 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Injury, poisoning and procedural complications Fall	18.5% 20/108 • Number of events 27 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	14.5% 16/110 • Number of events 37 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	13.9% 15/108 • Number of events 19 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Investigations Electrocardiogram pr prolongation	3.7% 4/108 • Number of events 10 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 15 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.6% 5/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Investigations Electrocardiogram qt prolonged	7.4% 8/108 • Number of events 15 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	9.1% 10/110 • Number of events 16 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.6% 5/108 • Number of events 10 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Investigations Weight decreased	5.6% 6/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	3.7% 4/108 • Number of events 4 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 9/108 • Number of events 11 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	3.6% 4/110 • Number of events 5 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	6.5% 7/108 • Number of events 7 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Musculoskeletal and connective tissue disorders Back pain	7.4% 8/108 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.5% 5/110 • Number of events 5 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.6% 6/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Musculoskeletal and connective tissue disorders Muscle spasms	3.7% 4/108 • Number of events 4 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.5% 6/110 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	2.8% 3/108 • Number of events 3 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 5/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.8% 2/110 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.6% 6/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Nervous system disorders Dizziness	6.5% 7/108 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 13 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	8.3% 9/108 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Nervous system disorders Headache	14.8% 16/108 • Number of events 88 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	11.8% 13/110 • Number of events 15 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.6% 6/108 • Number of events 6 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Nervous system disorders Tremor	3.7% 4/108 • Number of events 4 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.5% 6/110 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Psychiatric disorders Anxiety	7.4% 8/108 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	7.3% 8/110 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.6% 5/108 • Number of events 9 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Psychiatric disorders Depression	6.5% 7/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.8% 2/110 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	2.8% 3/108 • Number of events 3 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Reproductive system and breast disorders Benign prostatic hyperplasia	5.1% 2/39 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	4.3% 2/46 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	0.00% 0/40 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 7/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	2.7% 3/110 • Number of events 3 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	5.6% 6/108 • Number of events 8 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.
Vascular disorders Hypertension	1.9% 2/108 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	1.8% 2/110 • Number of events 2 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.	8.3% 9/108 • Number of events 11 • Baseline Up To 124 Weeks All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had number of participants at risk adjusted accordingly. One death is noted in participant flow for '3 mg LY3372689' arm, while two are reported under adverse events. This is because a participant who discontinued due to an AE later died-counted as "AE leading to death" in adverse events, but only as "discontinuation due to AE" in participant flow.