Trial Outcomes & Findings for A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy. (NCT NCT05421078)

NCT ID: NCT05421078

Last Updated: 2024-10-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 102 participants
• Primary outcome timeframe: 8 Weeks
• Results posted on: 2024-10-29

Participant Flow

Participant milestones

Measure	Placebo Once-daily placebo Obicetrapib: No active ingredient	Experimental 2.5 mg Obicetrapib once-daily Obicetrapib Obicetrapib: tablet	Experimental 5 mg Obicetrapib once-daily Obicetrapib Obicetrapib: tablet	Experimental 10 mg Obicetrapib once-daily Obicetrapib Obicetrapib: tablet
Overall Study STARTED	26	25	25	26
Overall Study COMPLETED	26	25	25	26
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Baseline characteristics by cohort

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet	Total n=102 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values	110.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 37.13 • n=5 Participants	102.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 26.58 • n=7 Participants	106.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.54 • n=5 Participants	109.1 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 32.47 • n=4 Participants	106.95 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.93 • n=21 Participants
Age, Continuous	63.3 years STANDARD_DEVIATION 9.44 • n=5 Participants	65.8 years STANDARD_DEVIATION 8.09 • n=7 Participants	67.8 years STANDARD_DEVIATION 9.46 • n=5 Participants	62.5 years STANDARD_DEVIATION 9.90 • n=4 Participants	64.8 years STANDARD_DEVIATION 9.36 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	73 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	26 Participants n=4 Participants	102 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	26 Participants n=4 Participants	102 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	-0.78 percent change from baseline Standard Deviation 14.581	-25.90 percent change from baseline Standard Deviation 21.259	-33.78 percent change from baseline Standard Deviation 13.247	-36.80 percent change from baseline Standard Deviation 25.727

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	-0.89 percent change from baseline Interval -38.6 to 27.8	-24.81 percent change from baseline Interval -66.0 to 17.7	-31.94 percent change from baseline Interval -56.8 to -2.9	-45.80 percent change from baseline Interval -73.0 to 45.5

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	-0.48 percent change from baseline Standard Error 3.766	-26.32 percent change from baseline Standard Error 3.844	-33.82 percent change from baseline Standard Error 3.838	-36.60 percent change from baseline Standard Error 3.765

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	0.43 percent change from baseline Standard Deviation 15.456	-26.10 percent change from baseline Standard Deviation 23.477	-30.50 percent change from baseline Standard Deviation 14.959	-36.29 percent change from baseline Standard Deviation 24.513

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	0.67 percent change from baseline Interval -35.3 to 32.5	-25.97 percent change from baseline Interval -67.6 to 41.9	-30.40 percent change from baseline Interval -57.8 to -2.7	-43.72 percent change from baseline Interval -72.0 to 30.9

PRIMARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	0.69 percent change from baseline Standard Error 3.928	-26.51 percent change from baseline Standard Error 4.013	-30.54 percent change from baseline Standard Error 4.002	-36.12 percent change from baseline Standard Error 3.926

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Mean Percent Change in Apolipoprotein B (ApoB)	-1.23 percent change from baseline Standard Deviation 10.614	-19.80 percent change from baseline Standard Deviation 15.363	-24.48 percent change from baseline Standard Deviation 13.909	-26.66 percent change from baseline Standard Deviation 15.0

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Median Percent Change in Apolipoprotein B (ApoB)	-0.36 percent change from baseline Interval -26.1 to 21.7	-22.50 percent change from baseline Interval -45.6 to 12.7	-21.43 percent change from baseline Interval -53.4 to 1.0	-29.67 percent change from baseline Interval -56.4 to 9.5

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
LS Mean Percent Change in Apolipoprotein B (ApoB)	-1.42 percent change from baseline Standard Error 2.407	-20.43 percent change from baseline Standard Error 2.457	-23.87 percent change from baseline Standard Error 2.457	-26.29 percent change from baseline Standard Error 2.408

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	-1.80 percent change from baseline Standard Deviation 12.328	-25.42 percent change from baseline Standard Deviation 19.280	-30.38 percent change from baseline Standard Deviation 13.839	-30.25 percent change from baseline Standard Deviation 23.318

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	-0.37 percent change from baseline Interval -33.3 to 24.2	-23.74 percent change from baseline Interval -62.4 to 15.6	-29.82 percent change from baseline Interval -52.8 to 1.3	-36.96 percent change from baseline Interval -66.3 to 35.8

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	-1.72 percent change from baseline Standard Error 3.395	-25.66 percent change from baseline Standard Error 3.463	-30.11 percent change from baseline Standard Error 3.463	-30.28 percent change from baseline Standard Error 3.395

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	5.57 percent change from baseline Standard Deviation 13.271	134.75 percent change from baseline Standard Deviation 56.543	153.16 percent change from baseline Standard Deviation 46.879	158.75 percent change from baseline Standard Deviation 43.171

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	5.22 percent change from baseline Interval -20.7 to 33.3	114.29 percent change from baseline Interval 57.3 to 307.0	144.44 percent change from baseline Interval 74.1 to 255.2	158.90 percent change from baseline Interval 76.6 to 281.6

SECONDARY outcome

Timeframe: 8 Weeks

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

Outcome measures

Measure	Placebo n=26 Participants Once-daily placebo Obicetrapib: No active ingredient	2.5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	5 mg Obicetrapib n=25 Participants once-daily Obicetrapib Obicetrapib: tablet	10 mg Obicetrapib n=26 Participants once-daily Obicetrapib Obicetrapib: tablet
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	3.90 percent change from baseline Standard Error 7.141	137.00 percent change from baseline Standard Error 7.284	151.30 percent change from baseline Standard Error 7.282	159.87 percent change from baseline Standard Error 7.139

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Experimental 2.5 mg Obicetrapib

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Experimental 5 mg Obicetrapib

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Experimental 10 mg Obicetrapib

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=26 participants at risk Once-daily placebo Obicetrapib: No active ingredient	Experimental 2.5 mg Obicetrapib n=25 participants at risk once-daily Obicetrapib Obicetrapib: tablet	Experimental 5 mg Obicetrapib n=25 participants at risk once-daily Obicetrapib Obicetrapib: tablet	Experimental 10 mg Obicetrapib n=26 participants at risk once-daily Obicetrapib Obicetrapib: tablet
Cardiac disorders Angina pectoris	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.

Other adverse events

Measure	Placebo n=26 participants at risk Once-daily placebo Obicetrapib: No active ingredient	Experimental 2.5 mg Obicetrapib n=25 participants at risk once-daily Obicetrapib Obicetrapib: tablet	Experimental 5 mg Obicetrapib n=25 participants at risk once-daily Obicetrapib Obicetrapib: tablet	Experimental 10 mg Obicetrapib n=26 participants at risk once-daily Obicetrapib Obicetrapib: tablet
Infections and infestations Nasopharyngitis	11.5% 3/26 • Number of events 3 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	7.7% 2/26 • Number of events 2 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pharyngitis	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Infections and infestations Rhinitis	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	8.0% 2/25 • Number of events 2 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	8.0% 2/25 • Number of events 5 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 2/26 • Number of events 2 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Gout	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	11.5% 3/26 • Number of events 3 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	7.7% 2/26 • Number of events 2 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Blood pressure increased	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Blood creatine phosphokinase increased	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Blood glucose increased	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Blood potassium increased	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations Blood pressure decreased	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Investigations C-reactive protein increased	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Humerus fracture	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Injury corneal	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Palpitations	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Chest pain	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Pyrexia	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
General disorders Vaccination site pain	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	7.7% 2/26 • Number of events 2 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	4.0% 1/25 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Eye disorders Conjunctivitis allergic	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholelithiasis	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/26 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	0.00% 0/25 • From first dose of study drug through Week 12 Safety Population included all participants who received at least 1 dose of any study drug.	3.8% 1/26 • Number of events 1 • From first dose of study drug through Week 12 Safety Population included 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