A Study of LY3819469 in Participants With Elevated Lipopr... | NCT05565742

ID	Type	Description	Link
J3L-MC-EZEB	Other Identifier	Eli Lilly and Company
2022-501426-38-00	EU Trial (CTIS) Number

Label	Type	Description	Intervention Names
16 mg LY3819469	Experimental	Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.	Drug: LY3819469
96 mg LY3819469	Experimental	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.	Drug: LY3819469
400 mg LY3819469	Experimental	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.	Drug: LY3819469
400 mg LY3819469 + Placebo	Experimental	Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.	Drug: LY3819469 Drug: Placebo
Placebo	Placebo Comparator	Participants received placebo on day 1 and day 180, administered as a SC injection.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3819469	Drug	Administered SC	16 mg LY3819469 400 mg LY3819469 400 mg LY3819469 + Placebo 96 mg LY3819469

Measure	Description	Time Frame
Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180	LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.	Baseline, Days 60 - 180

Measure	Description	Time Frame
Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360	LPa levels were assessed using Immuno turbidimetric method. LS mean was determined using MMRM model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment*Time (Type III sum of squares) as post-baseline measures.. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be at least 40 years old at the time of signing the informed consent.
Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:
- lipid-lowering drugs
- testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
- Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.

Male and/or Female

Males who agree to use highly effective/effective methods of contraception may participate in this trial.
Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria:

Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
- major surgery
- coronary, carotid, or peripheral arterial revascularization
- stroke or transient ischemic attack
- myocardial infarction or unstable angina
- acute limb ischemia
Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
Have uncontrolled hypertension

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Care Access - 801 South Power Road, Mesa		Mesa	Arizona	85206	United States
Care Access - South Pasadena

PubMed Identifier	Type	Citation	Retractions
40162643	Derived	Nissen SE, Ni W, Shen X, Wang Q, Navar AM, Nicholls SJ, Wolski K, Michael L, Haupt A, Krege JH; ALPACA Trial Investigators. Lepodisiran - A Long-Duration Small Interfering RNA Targeting Lipoprotein(a). N Engl J Med. 2025 May 1;392(17):1673-1683. doi: 10.1056/NEJMoa2415818. Epub 2025 Mar 30.
38970537	Derived

Label	URL
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) \[Lp(a)\]	View source

ID	Title	Description
FG000	16 mg LY3819469	Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
FG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 19, 2022	Mar 28, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180

LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Full Analysis Set. As specified in the Protocol and statistical analysis plan (SAP), for the primary analysis up to Day 180, the two LY3819469 treatment groups assigned to 400 mg (400 mg LY3819469, 400 mg LY3819469 + placebo) were pooled into one treatment group (400 mg LY3819469 pooled) because participants received the same study intervention in the first 180 days

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Days 60 - 180

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
OG003	Placebo	Participants received placebo on day 1 and day 180, administered as a SC injection.

Units	Counts
Participants	OG00036 OG00174 OG002141 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-39.0± 7.37 OG001-74.4± 2.16 OG002-93.7± 0.38 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Mixed Models Analysis		<0.001		LS Mean difference (Final Values)	-40.8	Standard Error of the Mean	8.82	2-Sided	95	-55.8	-20.6					Superiority
OG001 OG003		Mixed Models Analysis

Secondary

Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360

LPa levels were assessed using Immuno turbidimetric method. LS mean was determined using MMRM model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment*Time (Type III sum of squares) as post-baseline measures.. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Efficacy Analysis Set.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Days 240 - 360

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG003	400 mg LY3819469 + Placebo

Secondary

Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180

Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (nmol/L) at Days 60, 180 is reported.

Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

As specified in the protocol and SAP, for the primary analysis up to Day 180, two LY3819469 treatment groups assigned to 400 mg (400 mg LY3819469,400 mg LY3819469 + placebo) were pooled into one treatment group (400 mg LY3819469 pooled) because participants are receiving same study intervention in the first 180 days.

Posted

Number

percentage of participants

Days 60, 180

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled)	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.

Secondary

Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540

Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540 is reported.

Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

Posted

Number

percentage of participants

Days 240, 360, and 540

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG003	400 mg LY3819469 + Placebo	Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.

Secondary

Percent Change From Baseline in Lp(a)

LS mean was determined using MMRM model with log(Actual Measurement/Baseline) = log (Baseline) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment*Time (Type III sum of squares) as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Days 60, 180, 240, 360, and 540

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.

Secondary

Percent Change From Baseline in Apolipoprotein B (ApoB)

LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (<275 nmol/L vs. >=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Days 60, 180, 240, 360, and 540

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.

Secondary

Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)

hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation. LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (<275 nmol/L vs. >=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

Efficacy Analysis Set. Overall Number of Participants Analyzed = number of participants in each group. Number Analyzed = participants with available data at specified time points.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Days 60, 180, 240, 360, and 540

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469

Secondary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3819469

AUC was computed using the population PK model. Therefore, the concentrations are simulated from time 0 to infinity to estimate AUC for each participant. The timeframe reflects the PK timepoints that were collected to develop the population PK. Although this is a multiple dose study, the plasma PK is very short, so AUC0-180days is equivalent to AUC0-infinity.

All randomized participants who received at least one dose of study drug and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram*hour per milliliter (ng*hr/mL)

Day 1: 0.5 hours, 4-9 hours post-dose; Day 180: 24-36 hours post-dose

ID	Title	Description
OG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
OG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG0031 events1 affected72 at risk EG0040 events0 affected69 at risk
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Glaucoma	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Cardiac death	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0021 events1 affected69 at risk EG003
Complicated appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Pilonidal disease	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected35 at risk EG0020 events0 affected35 at risk EG003
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0021 events1 affected69 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected69 at risk EG003
Pelvic floor dysfunction	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003
Coronary angioplasty	Surgical and medical procedures	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0025 events4 affected69 at risk EG0032 events2 affected72 at risk EG0043 events3 affected69 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected69 at risk EG003
Injection site reaction	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0018 events6 affected74 at risk EG0029 events8 affected69 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected74 at risk EG0025 events5 affected69 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0021 events1 affected69 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected36 at risk EG0019 events7 affected74 at risk EG0023 events2 affected69 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected36 at risk EG0016 events6 affected74 at risk EG0025 events5 affected69 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0018 events5 affected74 at risk EG0023 events3 affected69 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected36 at risk EG0012 events2 affected74 at risk EG0027 events4 affected69 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0024 events4 affected69 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0024 events4 affected69 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected36 at risk EG0012 events2 affected74 at risk EG0020 events0 affected69 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected36 at risk EG0012 events2 affected74 at risk EG0023 events3 affected69 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0022 events2 affected69 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0013 events2 affected74 at risk EG0023 events3 affected69 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected35 at risk EG0020 events0 affected35 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected36 at risk EG0014 events4 affected74 at risk EG0022 events2 affected69 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected69 at risk EG003

ID	Title	Description
BG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
BG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
BG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
BG003	400 mg LY3819469 + Placebo	Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
BG004	Placebo	Participants received placebo on day 1 and day 180, administered as a SC injection.
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	16 mg LY3819469	Participants received 16 mg of LY3819469 on day 1 and day 180, administered as a SC injection	1	36	1	36	14	36
EG001	96 mg LY3819469	Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.	0	74	9	74	25	74
EG002	400 mg LY3819469	Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.	0	69	11	69	34	69
EG003	400 mg LY3819469 + Placebo	Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.	0	72	8	72	35	72
EG004	Placebo	Participants received placebo on day 1 and day 180, administered as a SC injection.	0	69	6	69	26	69