Trial Outcomes & Findings for Randomized Study of Obicetrapib in Combination With Ezetimibe (NCT NCT04770389)

Results Overview

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-04-24

Participant Flow

234 participants were screened; out of 234, 112 participants were randomized. One participant in the ezetimibe 10 mg group was randomized in error and did not participate in the study or receive study drug

Participant milestones

Participant milestones
Measure	Placebo placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Combination Therapy 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet	Obicetrapib Monotherapy 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet	Ezetimibe Monotherapy placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet
Overall Study STARTED	28	27	28	29
Overall Study COMPLETED	26	22	26	24
Overall Study NOT COMPLETED	2	5	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Combination Therapy 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet	Obicetrapib Monotherapy 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet	Ezetimibe Monotherapy placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet
Overall Study Adverse Event	1	2	0	1
Overall Study Withdrawal by Subject	0	2	1	0
Overall Study Failed attempt to draw blood	1	0	0	0
Overall Study Left the country	0	0	1	2
Overall Study Randomized in error and did not receive study drug	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Moved away from study site	0	1	0	0

Baseline Characteristics

Randomized Study of Obicetrapib in Combination With Ezetimibe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Combination Therapy n=27 Participants 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet	Obicetrapib Monotherapy n=28 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet	Ezetimibe Monotherapy n=28 Participants placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet	Total n=111 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 9.81 • n=93 Participants	53.5 years STANDARD_DEVIATION 11.43 • n=4 Participants	59.1 years STANDARD_DEVIATION 7.50 • n=27 Participants	54.4 years STANDARD_DEVIATION 9.55 • n=483 Participants	55.4 years STANDARD_DEVIATION 9.78 • n=36 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	16 Participants n=4 Participants	14 Participants n=27 Participants	14 Participants n=483 Participants	60 Participants n=36 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	11 Participants n=4 Participants	14 Participants n=27 Participants	14 Participants n=483 Participants	51 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants	26 Participants n=4 Participants	27 Participants n=27 Participants	25 Participants n=483 Participants	104 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	6 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	4 Participants n=483 Participants	16 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants	22 Participants n=4 Participants	23 Participants n=27 Participants	24 Participants n=483 Participants	93 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values	136.8 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 19.86 • n=93 Participants	132.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.48 • n=4 Participants	127.5 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 20.87 • n=27 Participants	128.0 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 22.33 • n=483 Participants	131.13 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 22.64 • n=36 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]	-0.17 percent change from baseline Standard Deviation 12.682	-45.63 percent change from baseline Standard Deviation 21.677

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]	-1.40 percent change from baseline Interval -20.9 to 33.6	-51.95 percent change from baseline Interval -77.9 to 3.1

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=27 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]	1.37 percent change from baseline Standard Error 3.604	-43.55 percent change from baseline Standard Error 3.746

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]	-1.53 percent change from baseline Standard Deviation 15.105	-44.38 percent change from baseline Standard Deviation 20.731

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]	-2.00 percent change from baseline Interval -24.5 to 35.9	-51.40 percent change from baseline Interval -69.6 to 8.1

PRIMARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]	-0.78 percent change from baseline Standard Error 4.012	-44.10 percent change from baseline Standard Error 3.813

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]	-0.17 percent change from baseline Standard Deviation 12.682	-31.88 percent change from baseline Standard Deviation 18.860

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]	-1.40 percent change from baseline Interval -20.9 to 33.6	-34.40 percent change from baseline Interval -57.0 to 23.8

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=28 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]	1.37 percent change from baseline Standard Error 3.604	-31.99 percent change from baseline Standard Error 3.686

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]	-1.53 percent change from baseline Standard Deviation 15.105	-27.94 percent change from baseline Standard Deviation 18.914

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]	-2.00 percent change from baseline Interval -24.5 to 35.9	-30.10 percent change from baseline Interval -56.7 to 19.1

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]	-0.78 percent change from baseline Standard Error 4.012	-28.98 percent change from baseline Standard Error 3.802

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo	-1.17 percent change from baseline Standard Deviation 11.692	-31.62 percent change from baseline Standard Deviation 15.521

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo	-0.90 percent change from baseline Interval -19.8 to 25.4	-34.75 percent change from baseline Interval -53.0 to 8.9

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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

LS Mean percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=27 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo	-0.11 percent change from baseline Standard Error 2.626	-29.73 percent change from baseline Standard Error 2.730

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in Apo-B from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=26 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo	-1.17 percent change from baseline Standard Deviation 11.692	-22.15 percent change from baseline Standard Deviation 13.356

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baselinevalue for LDL-C assessment.

Median percent change in Apo-B from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=26 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo	-0.90 percent change from baseline Interval -19.8 to 25.4	-23.50 percent change from baseline Interval -39.3 to 21.2

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in Apo-B from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=28 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo	-0.11 percent change from baseline Standard Error 2.626	-22.46 percent change from baseline Standard Error 2.675

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]	-12.69 percent change from baseline Standard Deviation 21.316	-45.63 percent change from baseline Standard Deviation 21.677

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]	-14.80 percent change from baseline Interval -51.9 to 59.1	-51.95 percent change from baseline Interval -77.9 to 3.1

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=27 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]	-13.42 percent change from baseline Standard Error 3.675	-43.55 percent change from baseline Standard Error 3.746

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]	-12.69 percent change from baseline Standard Deviation 21.316	-31.88 percent change from baseline Standard Deviation 18.860

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]	-14.80 percent change from baseline Interval -51.9 to 59.1	-34.40 percent change from baseline Interval -57.0 to 23.8

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=28 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]	-13.42 percent change from baseline Standard Error 3.675	-31.99 percent change from baseline Standard Error 3.686

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]	-0.17 percent change from baseline Standard Deviation 12.682	-12.69 percent change from baseline Standard Deviation 21.316

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=25 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]	-1.40 percent change from baseline Interval -20.9 to 33.6	-14.80 percent change from baseline Interval -51.9 to 59.1

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=28 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]	1.37 percent change from baseline Standard Error 3.604	-13.42 percent change from baseline Standard Error 3.675

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=23 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]	-1.53 percent change from baseline Standard Deviation 15.105	-13.68 percent change from baseline Standard Deviation 19.573

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=23 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]	-2.00 percent change from baseline Interval -24.5 to 35.9	-14.90 percent change from baseline Interval -46.8 to 46.9

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=23 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]	-0.78 percent change from baseline Standard Error 4.012	-13.55 percent change from baseline Standard Error 3.891

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Mean percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy	-8.78 percent change from baseline Standard Deviation 14.445	-31.62 percent change from baseline Standard Deviation 15.521

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

Median percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=24 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy	-8.90 percent change from baseline Interval -45.4 to 32.3	-34.75 percent change from baseline Interval -53.0 to 8.9

SECONDARY outcome

Timeframe: 8 weeks

Population: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. 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.

LS Mean Percent change in ApoB from baseline to Day 57

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Obicetrapib Monotherapy n=27 Participants 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy	-8.92 percent change from baseline Standard Error 2.675	-29.73 percent change from baseline Standard Error 2.730

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Combination Therapy

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Obicetrapib Monotherapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ezetimibe Monotherapy

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=28 participants at risk placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Combination Therapy n=27 participants at risk 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet	Obicetrapib Monotherapy n=28 participants at risk 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet	Ezetimibe Monotherapy n=28 participants at risk placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.

Other adverse events

Additional Information

Study Director

NewAmsterdam Pharma

Phone: +1(305) 627-3081

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=28 participants at risk placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet	Combination Therapy n=27 participants at risk 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet	Obicetrapib Monotherapy n=28 participants at risk 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet	Ezetimibe Monotherapy n=28 participants at risk placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet
Gastrointestinal disorders Diarrhoea	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	7.4% 2/27 • Number of events 3 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	7.1% 2/28 • Number of events 2 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain upper	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Flatulence	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Gastroenteritis	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Influenza	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Onychomycosis	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	3.6% 1/28 • Number of events 2 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	7.1% 2/28 • Number of events 2 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 2 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Sciatica	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Palpitations	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Non-cardiac chest pain	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations SARS-CoV-2 test positive	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Nail fold inflammation	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/27 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.6% 1/28 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	3.7% 1/27 • Number of events 1 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/28 • From first dose of study drug through Week 16 Safety Population included all participants who received at least 1 dose of any study drug.