Trial Outcomes & Findings for Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy (NCT NCT05266586)

NCT ID: NCT05266586

Last Updated: 2024-07-03

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 119 participants
• Primary outcome timeframe: 12-weeks
• Results posted on: 2024-07-03

Participant Flow

231 participants were screened; out of 231, 119 participants were randomized.

Participant milestones

Measure	Placebo once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Monotherapy once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	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.
Overall Study STARTED	40	39	40
Overall Study COMPLETED	36	36	38
Overall Study NOT COMPLETED	4	3	2

Reasons for withdrawal

Measure	Placebo once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Monotherapy once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	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.
Overall Study Adverse Event	2	2	1
Overall Study Withdrawal by Subject	1	0	1
Overall Study Non-compliance with study drug	0	1	0
Overall Study Subject unable to adhere to all protocol requirements	1	0	0

Baseline Characteristics

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Baseline characteristics by cohort

Measure	Placebo n=40 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Monotherapy n=26 Participants once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.	Total n=97 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 8.46 • n=93 Participants	64.8 years STANDARD_DEVIATION 7.24 • n=4 Participants	63.5 years STANDARD_DEVIATION 9.08 • n=27 Participants	62.6 years STANDARD_DEVIATION 8.48 • n=483 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants	35 Participants n=483 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	17 Participants n=4 Participants	19 Participants n=27 Participants	62 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=93 Participants	24 Participants n=4 Participants	28 Participants n=27 Participants	87 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 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
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 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
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	14 Participants n=483 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	23 Participants n=4 Participants	29 Participants n=27 Participants	82 Participants n=483 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
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
Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values	99.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.06 • n=93 Participants	100.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 33.65 • n=4 Participants	96.0 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 25.62 • n=27 Participants	98.57 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 28.78 • n=483 Participants

PRIMARY outcome

Timeframe: 12-weeks

Population: 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

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-0.83 percent change from baseline Standard Deviation 24.514	-59.07 percent change from baseline Standard Deviation 14.814

PRIMARY outcome

Timeframe: 12-Weeks

Population: 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

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-6.35 percent change from baseline Interval -36.4 to 96.7	-63.40 percent change from baseline Interval -83.7 to -29.7

PRIMARY outcome

Timeframe: 12-Weeks

Population: 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

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).

Outcome measures

Measure	Placebo n=40 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]	-0.85 percent change from baseline Standard Error 3.472	-59.23 percent change from baseline Standard Error 3.786

PRIMARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-1.49 percent change from baseline Standard Deviation 23.762	-59.51 percent change from baseline Standard Deviation 15.192

PRIMARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-3.95 percent change from baseline Interval -34.3 to 91.8	-62.80 percent change from baseline Interval -82.3 to -31.0

PRIMARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]	-1.54 percent change from baseline Standard Error 3.533	-59.69 percent change from baseline Standard Error 3.811

SECONDARY outcome

Timeframe: 12-weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-0.83 percent change from baseline Standard Deviation 24.514	-39.35 percent change from baseline Standard Deviation 22.602

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-6.35 percent change from baseline Interval -36.4 to 96.7	-43.50 percent change from baseline Interval -78.4 to 22.6

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=40 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]	-0.85 percent change from baseline Standard Error 3.472	-39.20 percent change from baseline Standard Error 4.133

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-1.49 percent change from baseline Standard Deviation 23.762	-39.04 percent change from baseline Standard Deviation 23.456

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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 level was measured by preparative ultracentrifugation (PUC).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-3.95 percent change from baseline Interval -34.3 to 91.8	-43.55 percent change from baseline Interval -78.4 to 20.4

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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).

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]	-1.54 percent change from baseline Standard Error 3.533	-38.75 percent change from baseline Standard Error 4.166

SECONDARY outcome

Timeframe: 12-weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	0.51 percent change from baseline Standard Deviation 19.784	-34.66 percent change from baseline Standard Deviation 11.796

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	-2.05 percent change from baseline Interval -30.9 to 76.9	-34.40 percent change from baseline Interval -54.3 to -14.7

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=40 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=31 Participants 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.
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo	0.72 percent change from baseline Standard Error 2.572	-34.95 percent change from baseline Standard Error 2.796

SECONDARY outcome

Timeframe: 12-weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	0.51 percent change from baseline Standard Deviation 19.784	-21.73 percent change from baseline Standard Deviation 16.057

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=36 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	-2.05 percent change from baseline Interval -30.9 to 76.9	-24.20 percent change from baseline Interval -44.8 to 27.1

SECONDARY outcome

Timeframe: 12-Weeks

Population: 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.

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

Outcome measures

Measure	Placebo n=40 Participants once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=26 Participants 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.
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo	0.72 percent change from baseline Standard Error 2.572	-21.56 percent change from baseline Standard Error 3.052

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Monotherapy

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Combination Therapy

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=40 participants at risk once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Monotherapy n=39 participants at risk once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=40 participants at risk 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.
Cardiac disorders Acute myocardial infarction	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular accident	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.

Other adverse events

Measure	Placebo n=40 participants at risk once-daily placebo tablet and placebo capsule Obicetrapib placebo: tablets; no active ingredient Ezetimibe placebo: capsules; no active ingredient	Monotherapy n=39 participants at risk once-daily obicetrapib 10 mg tablet and placebo capsule Obicetrapib: tablets Ezetimibe placebo: capsules; no active ingredient	Combination Therapy n=40 participants at risk 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.
Infections and infestations Urinary tract infection	5.0% 2/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations Acute sinusitis	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations Bronchitis	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations Nasopharyngitis	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations Pharyngitis	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Infections and infestations Tooth infection	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	5.0% 2/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	5.0% 2/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Muscle strain	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 3 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	5.0% 2/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Burning sensation	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular accident	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness postural	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Migraine	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Nervous system disorders Tremor	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Investigations Blood creatine phosphokinase increased	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Investigations Haemoglobin decreased	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Investigations Hepatic enzyme increased	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Investigations Weight increased	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.0% 2/40 • Number of events 2 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Cardiac disorders Coronary artery disease	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Cardiac disorders Tachycardia	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	2.6% 1/39 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Pollakiuria	2.5% 1/40 • Number of events 1 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/39 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.	0.00% 0/40 • From first dose of study drug through Week 16 The Safety Population was defined as all participants who received at least 1 dose of any study drug.

Additional Information

Study Director

NewAmsterdam Pharma

Phone: +1(305) 627-3081

Email: study.director@newamsterdampharma.com

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