Study to Evaluate the Effect of Obicetrapib in Combinatio... | NCT05266586

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	once-daily placebo tablet and placebo capsule	Other: Obicetrapib placebo Other: Ezetimibe placebo
monotherapy	Experimental	once-daily obicetrapib 10 mg tablet and placebo capsule	Drug: Obicetrapib Other: Ezetimibe placebo
combination therapy	Experimental	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule	Drug: Obicetrapib Drug: Ezetimibe 10mg

Name	Type	Description	Arm Group Labels	Other Names
Obicetrapib	Drug	tablets	combination therapy monotherapy

Measure	Description	Time Frame
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).	12-weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).	12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).	12-Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Measure	Description	Time Frame
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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).

Name	Affiliation	Role
Marc Ditmarsch	NewAmsterdam Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Velocity Clinical Research - Westlake d.b.a National Research Institute		Los Angeles	California	90057	United States

ID	Title	Description
FG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
FG001	Monotherapy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 16, 2021	Jun 6, 2024

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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).

On-treatment defined as all randomized participants who received at least 1 dose of any study drug and had a baseline value for low-density lipoprotein cholesterol (LDL-C), excluding those with PK evidence suggesting participant misconduct, i.e., plasma obicetrapib < 100 ng/mL

Posted

Mean

Standard Deviation

percent change from baseline

12-weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts
Participants	OG00036 OG00131

Title

Denominators

Categories

Title	Measurements
	OG000-0.83± 24.514 OG001-59.07± 14.814

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		Least Squares (LS) Means	-58.38	Standard Error of the Mean	5.138	2-Sided	95	-68.59	-48.18					Superiority

Primary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Primary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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).

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Primary

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Posted

Mean

Standard Deviation

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts

Primary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts

Primary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts

Secondary

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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).

Posted

Mean

Standard Deviation

percent change from baseline

12-weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Secondary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

Median percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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).

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Secondary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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).

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Secondary

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

Posted

Mean

Standard Deviation

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Secondary

Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Secondary

LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Secondary

Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

Posted

Mean

Standard Deviation

percent change from baseline

12-weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts
Participants

Secondary

Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts
Participants

Secondary

LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Units	Counts
Participants

Secondary

Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group

Posted

Mean

Standard Deviation

percent change from baseline

12-weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Secondary

Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group

Posted

Median

Full Range

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Secondary

LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group

Posted

Least Squares Mean

Standard Error

percent change from baseline

12-Weeks

ID	Title	Description
OG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
OG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
COVID-19	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0022 events1 affected40 at risk
Acute sinusitis	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Bronchitis	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Pharyngitis	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Tooth infection	Infections and infestations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected39 at risk EG0022 events2 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0021 events1 affected40 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0013 events1 affected39 at risk EG0020 events0 affected40 at risk
Headache	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0002 events2 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Dizziness	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Burning sensation	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Dizziness postural	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Migraine	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Tremor	Nervous system disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Haemoglobin decreased	Investigations	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Hepatic enzyme increased	Investigations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Weight increased	Investigations	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected40 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Coronary artery disease	Cardiac disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Tachycardia	Cardiac disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA v24.1	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected40 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v24.1	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected40 at risk

ID	Term
D050171	Dyslipidemias
D006937	Hypercholesterolemia
D050197	Atherosclerosis

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Placebo	once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient
BG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient
BG002	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
BG003	Total	Total of all reporting groups

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 tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	40	1	40	16	40
EG001	Monotherapy	once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	39	1	39	8	39
EG002	Combination Therapy	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Obicetrapib: tablets Ezetimibe 10mg: capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.	40	0	40	11	40