A Dose-Finding Study in Japanese Patients to Evaluate the... | NCT05421078

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Once-daily placebo	Drug: Placebo
2.5 mg Obicetrapib	Experimental	once-daily Obicetrapib	Drug: Obicetrapib
5 mg Obicetrapib	Experimental	once-daily Obicetrapib	Drug: Obicetrapib
10 mg Obicetrapib	Experimental	once-daily Obicetrapib	Drug: Obicetrapib

Name	Type	Description	Arm Group Labels	Other Names
Obicetrapib	Drug	tablet	10 mg Obicetrapib 2.5 mg Obicetrapib 5 mg Obicetrapib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).	8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)

Secondary Outcomes

Measure	Description	Time Frame
Mean Percent Change in Apolipoprotein B (ApoB)	Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8 Weeks
Median Percent Change in Apolipoprotein B (ApoB)

Name	Affiliation	Role
Marc Ditmarsch, MD	NewAmsterdam Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nippon Kokan Fukuyama Hospital		Fukuyama			Japan
Nakamura Cardiology and Cardiovascular Surgery Clinic

ID	Title	Description
FG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
FG001	Experimental 2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 20, 2022	Jul 9, 2024

ID	Title	Description
BG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
BG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
BG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
BG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00125 BG00225 BG00326 BG004102

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

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Mean

Standard Deviation

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Units	Counts
Participants	OG00026 OG00125 OG00225 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.78± 14.581 OG001-25.90± 21.259 OG002-33.78± 13.247 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	mixed model for repeated measures (MMRM) with missing at random assumption	<.0001	p value is calculated	Least Squares (LS) Means	-25.84	Standard Error of the Mean	5.387	2-Sided	95	-36.53	-15.14					Superiority
OG000 OG002

Primary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Median

Full Range

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Primary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Least Squares Mean

Standard Error

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Primary

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Mean

Standard Deviation

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Primary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Median

Full Range

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Primary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Least Squares Mean

Standard Error

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Mean Percent Change in Apolipoprotein B (ApoB)

Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Mean

Standard Deviation

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Median Percent Change in Apolipoprotein B (ApoB)

Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Median

Full Range

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

LS Mean Percent Change in Apolipoprotein B (ApoB)

Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Least Squares Mean

Standard Error

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Mean

Standard Deviation

percent change from baseline

8 weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Median

Full Range

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Least Squares Mean

Standard Error

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Mean

Standard Deviation

percent change from baseline

8 weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Median

Full Range

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Secondary

LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.

Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Posted

Least Squares Mean

Standard Error

percent change from baseline

8 Weeks

ID	Title	Description
OG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient
OG001	2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG002	5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet
OG003	10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0003 events3 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG0032 events2 affected26 at risk
COVID-19	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Pharyngitis	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Rhinitis	Infections and infestations	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0012 events2 affected25 at risk EG0020 events0 affected25 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0015 events2 affected25 at risk EG0020 events0 affected25 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0002 events2 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0003 events3 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Blood pressure increased	Investigations	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Blood glucose increased	Investigations	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Blood potassium increased	Investigations	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Blood pressure decreased	Investigations	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
C-reactive protein increased	Investigations	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Injury corneal	Injury, poisoning and procedural complications	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Palpitations	Cardiac disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Chest pain	General disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk EG003
Pyrexia	General disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Vaccination site pain	General disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Dizziness	Nervous system disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Hypertension	Vascular disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA v25.0	Systematic Assessment	EG0001 events1 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA v25.0	Systematic Assessment	EG0000 events0 affected26 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk EG003

ID	Term
D050171	Dyslipidemias
D006937	Hypercholesterolemia

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Once-daily placebo Obicetrapib: No active ingredient	26	0	26	15	26
EG001	Experimental 2.5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet	25	0	25	9	25
EG002	Experimental 5 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet	25	1	25	7	25
EG003	Experimental 10 mg Obicetrapib	once-daily Obicetrapib Obicetrapib: tablet	26	0	26	15	26