A Study of LY3561774 in Participants With Mixed Dyslipidemia | NCT05256654

ID	Type	Description	Link
J3F-MC-EZCB	Other Identifier	Eli Lilly and Company
2021-005407-13	EudraCT Number

A Study of LY3561774 in Participants With Mixed Dyslipidemia | NCT05256654 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3561774 100 mg	Experimental	Participants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	Drug: LY3561774
LY3561774 400 mg	Experimental	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	Drug: LY3561774
LY3561774 800 mg	Experimental	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	Drug: LY3561774
Placebo	Placebo Comparator	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3561774	Drug	Administered SC	LY3561774 100 mg LY3561774 400 mg LY3561774 800 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180	Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.	Baseline, Day 180

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180	Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.	Baseline, Day 180
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180

Eligibility Module

Contacts/Locations Module

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
Chase Medical Research, LLC		Waterbury	Connecticut	06708	United States
MD Medical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40179932	Derived	Ray KK, Oru E, Rosenson RS, Jones J, Ma X, Walgren J, Haupt A, Verma S, Gaudet D, Nicholls SJ, Ruotolo G. Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 May 3;405(10489):1594-1607. doi: 10.1016/S0140-6736(25)00507-0. Epub 2025 Mar 31.

Label	URL
A Study of LY3561774 in Participants With Mixed Dyslipidemia (PROLONG-ANG3)	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
FG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 14, 2023	Feb 28, 2025

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects
Withdrawal by Subject		FG0001 subjects FG0012 subjects FG0021 subjects FG0033 subjects
Earthquake at the Turkey site prevented participation in the study		FG0000 subjects FG0011 subjects FG0021 subjects FG0030 subjects
Other		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
BG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
BG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
BG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00058 ParticipantsBG00130 ParticipantsBG00258 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00058 ParticipantsBG00130 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00058 ParticipantsBG00130 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00058 ParticipantsBG00130 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
Argentina	ParticipantsBG00058 ParticipantsBG00130 ParticipantsBG002

Baseline Apolipoprotein B (ApoB)

Number of participants with non-missing data, used as denominator

Median

Full Range

milligram per deciliter (mg/dL)

Title	Denominators	Categories
	ParticipantsBG00056 ParticipantsBG00130 ParticipantsBG002

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 for Apolipoprotein B (ApoB) at Day 180

Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.

All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Units	Counts
Participants	OG00057 OG00130 OG00258 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-11.6± 3.65 OG001-14.1± 4.98 OG002-24.3± 3.10 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 OG001		Mixed Models Analysis		0.691		Mean Difference (Net)	-2.8	Standard Error of the Mean	6.92	2-Sided	95	-15.5	11.9			Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) <250 milligram per deciliter (mg/dL) or >=250 mg/dL at screening), and the interaction between treatment and time.		Superiority

Secondary

Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180

Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg

Secondary

Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180

Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg

Secondary

Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180

Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg

Secondary

Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180

Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 200 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg

Secondary

Percent Change From Baseline for Triglycerides at Day 180

Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 180

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)

Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable non HDL-C values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg

Secondary

Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)

Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)

Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Percent Change From Baseline for Apolipoprotein B (ApoB)

Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.

All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Percent Change From Baseline for Triglycerides

Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, Day 270

ID	Title	Description
OG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Secondary

Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774

PK: Seady State AUC (0-∞) of LY3561774

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*h/mL)

On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose

ID	Title	Description
OG000	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG001	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
OG002	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Units

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	57	5	57	16	57
EG001	LY3561774 100 mg	Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	30	1	30	14	30
EG002	LY3561774 400 mg	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	58	3	58	14	58
EG003	LY3561774 800 mg	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.	59	2	59	9	59

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG0030 events0 affected59 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG003
Brain abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected30 at risk EG0021 events1 affected58 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected30 at risk EG0020 events0 affected58 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected30 at risk EG0020 events0 affected58 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected30 at risk EG0021 events1 affected58 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0010 events0 affected30 at risk EG0021 events1 affected58 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected30 at risk EG0025 events3 affected58 at risk EG0031 events1 affected59 at risk
Covid-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected57 at risk EG0014 events4 affected30 at risk EG0023 events3 affected58 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected57 at risk EG0013 events3 affected30 at risk EG0022 events2 affected58 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0012 events2 affected30 at risk EG0022 events2 affected58 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected57 at risk EG0011 events1 affected30 at risk EG0025 events3 affected58 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected57 at risk EG0011 events1 affected30 at risk EG0021 events1 affected58 at risk EG003
Lipase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected57 at risk EG0010 events0 affected30 at risk EG0021 events1 affected58 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected57 at risk EG0013 events2 affected30 at risk EG0021 events1 affected58 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected57 at risk EG0012 events2 affected30 at risk EG0021 events1 affected58 at risk EG003

Title	Measurements
American Indian or Alaska Native	BG00021 BG00111 BG00214 BG00322 BG00468
Asian	BG00011 BG0016 BG00210 BG0039 BG004
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030 BG004
Black or African American	BG0001 BG0010 BG0020 BG0030 BG004
White	BG00025 BG00113 BG00234 BG00328 BG004
More than one race	BG0000 BG0010 BG0020 BG0030 BG004
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030 BG004

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	<.001	Mean Difference (Net)	-54.3	Standard Error of the Mean	5.08	2-Sided	95	-63.3	-43.1	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-69.8	Standard Error of the Mean	2.73	2-Sided	95	-74.8	-63.9	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-76.6	Standard Error of the Mean	2.13	2-Sided	95	-80.4	-72.0	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.854	Mean Difference (Net)	-1.3	Standard Error of the Mean	7.24	2-Sided	95	-14.6	14.0	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	0.002	Mean Difference (Net)	-16.8	Standard Error of the Mean	4.98	2-Sided	95	-26.0	-6.4	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	0.033	Mean Difference (Net)	-12.1	Standard Error of the Mean	5.28	2-Sided	95	-21.9	-1.1	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.143	Mean Difference (Net)	-6.1	Standard Error of the Mean	4.03	2-Sided	95	-13.8	2.2	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-16.4	Standard Error of the Mean	2.93	2-Sided	95	-22.0	-10.5	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-22.7	Standard Error of the Mean	2.71	2-Sided	95	-27.9	-17.2	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.068	Mean Difference (Net)	-10.8	Standard Error of the Mean	5.55	2-Sided	95	-21.1	0.9	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-25.5	Standard Error of the Mean	3.79	2-Sided	95	-32.6	-17.6	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-23.8	Standard Error of the Mean	3.88	2-Sided	95	-31.1	-15.7	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	<.001	Mean Difference (Net)	-36.3	Standard Error of the Mean	5.21	2-Sided	95	-45.8	-25.1	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-50.3	Standard Error of the Mean	3.31	2-Sided	95	-56.4	-43.3	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-52.5	Standard Error of the Mean	3.17	2-Sided	95	-58.4	-45.9	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	<.001	Mean Difference (Net)	-38.6	Standard Error of the Mean	7.76	2-Sided	95	-52.2	-21.2	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-54.0	Standard Error of the Mean	4.69	2-Sided	95	-62.4	-43.8	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-63.6	Standard Error of the Mean	3.72	2-Sided	95	-70.3	55.5	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.506	Mean Difference (Net)	-4.1	Standard Error of the Mean	5.99	2-Sided	95	-15.2	8.5	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-19.7	Standard Error of the Mean	4.04	2-Sided	95	-27.2	-11.3	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-19.4	Standard Error of the Mean	4.06	2-Sided	95	-27.0	-11.0	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.428	Mean Difference (Net)	-3.4	Standard Error of the Mean	4.16	2-Sided	95	-11.2	5.2	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	0.009	Mean Difference (Net)	-8.7	Standard Error of the Mean	3.14	2-Sided	95	-14.7	-2.3	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-12.2	Standard Error of the Mean	3.04	2-Sided	95	-18.0	-6.0	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.412	Mean Difference (Net)	6.5	Standard Error of the Mean	8.10	2-Sided	95	-8.4	23.7	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	0.104	Mean Difference (Net)	-9.5	Standard Error of the Mean	5.52	2-Sided	95	-19.7	2.1	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	0.363	Mean Difference (Net)	-5.4	Standard Error of the Mean	5.79	2-Sided	95	-16.2	6.7	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	0.101	Mean Difference (Net)	-10.8	Standard Error of the Mean	6.19	2-Sided	95	-22.2	2.3	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	0.033	Mean Difference (Net)	-11.3	Standard Error of the Mean	4.96	2-Sided	95	-20.6	-1.0	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	0.040	Mean Difference (Net)	-10.9	Standard Error of the Mean	4.98	2-Sided	95	-20.3	-0.6	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type
OG000 OG001	Mixed Models Analysis	<.001	Mean Difference (Net)	-28.3	Standard Error of the Mean	6.79	2-Sided	95	-40.5	-13.6	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG002	Mixed Models Analysis	<.001	Mean Difference (Net)	-42.5	Standard Error of the Mean	4.35	2-Sided	95	-50.5	-33.2	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority
OG000 OG003	Mixed Models Analysis	<.001	Mean Difference (Net)	-44.8	Standard Error of the Mean	4.20	2-Sided	95	-52.5	-35.9	Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG <250 mg/dL or >=250 mg/dL at screening), and the interaction between treatment and time.	Superiority

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D006951	Hyperlipoproteinemias

ID	Term
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias