mild dyslipidemia MedDRA version: 20.1 Level: LLT Classification code 10020049 Term: High cholesterol System Organ Class: 100000004848
Conditions
Sponsors
NewAmsterdam Pharma BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Understanding of the study procedures, willingness to adhere to the study schedules and diet, and agreement to participate in the study by giving written informed consent prior to Screening procedures; 2. Men or women 18 to 70 years of age, inclusive; o Women may be enrolled if all 3 of the following criteria are met: ? -They are not pregnant; ? -They are not breastfeeding; and ? -They do not plan on becoming pregnant during the study; o Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit. Note: Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the Investigator: ? -They have had a hysterectomy or tubal ligation at a minimum of 1 cycle prior to signing the ICF; or ? -They are post-menopausal, defined as 1 year since their last menstrual period for women 55 years of age or 1 year since their last menstrual period and have a follicle stimulating hormone (FSH) level in the menopausal range for women 2.5 mmol/L and =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Body mass index ?40 kg/m2; 2. Participation in another clinical study involving an investigational or marketed drug within 30 days prior to the Screening Visit; 3. Currently taking any lipid-altering therapy; 4. Any clinical manifestation of atherosclerotic CVD or any evidence of ischemic coronary disease present on the 12-lead ECG at the Screening Visit; 5. Diagnosis of type 1 or type 2 diabetes mellitus; or glycosylated hemoglobin (HbA1c) ?6.5% at the Screening Visit if no prior diagnosis of diabetes mellitus; 6. Uncontrolled hypertension, ie, sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >90 mmHg. One retest will be allowed, at which point if the retest result is no longer exclusionary, the participant may be randomized; 7. Active muscle disease or persistent creatine kinase concentration >3 ? the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result, at which point if the retest result is no longer exclusionary, the participant may be randomized; 8. History of torsades de pointes; 9. Estimated glomerular filtration rate 2 ? ULN, or total bilirubin >1.5 ? ULN; 11. Anemia, defined as hemoglobin concentration <11 g/dL for males and hemoglobin concentration <9 g/dL for females; 12. History of malignancy within the past 5 years, with the exception of non-melanoma skin cancers; 13. Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study; or 14. Known ezetimibe or CETP inhibitor allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of obicetrapib in combination with ezetimibe compared to placebo on low-density lipoprotein cholesterol (LDL-C) at Day 85.;Secondary Objective: •To evaluate the effect of obicetrapib monotherapy compared to placebo on LDL-C at Day 85; •To evaluate the effect of obicetrapib in combination with ezetimibe compared to placebo on apolipoprotein B (ApoB) at Day 85; •To evaluate the effect of obicetrapib monotherapy compared to placebo on ApoB at Day 85; •To evaluate the effect of ezetimibe monotherapy compared to placebo on LDL-C at Day 85; •To evaluate the effect of ezetimibe monotherapy compared to placebo on ApoB at Day 85; •To evaluate the effect of obicetrapib in combination with ezetimibe compared to obicetrapib monotherapy on LDL-C at Day 85; and •To evaluate the effect of obicetrapib in combination with ezetimibe compared to obicetrapib monotherapy on ApoB at Day 85. ;Primary end point(s): The primary efficacy endpoint is percent change from Day 1 to Day 85 in LDL-C, as measured by preparative ultracentrifugation, also referred to as beta quantification, for the combination therapy group compared to the placebo group.;Timepoint(s) of evaluation of this end point: Screening, Day 1, Day 29, day 57 and Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints include the following, in hierarchical order: • Percent change from Day 1 to Day 85 in LDL-C, as measured by preparative ultracentrifugation, also referred to as beta quantification, for the obicetrapib monotherapy group compared to the placebo group; • Percent change from Day 1 to Day 85 in ApoB for the combination therapy group compared to the placebo group; • Percent change from Day 1 to Day 85 in ApoB for the obicetrapib monotherapy group compared to the placebo group; • Percent change from Day 1 to Day 85 in LDL-C, as measured by preparative ultracentrifugation, also referred to as beta quantification, for the ezetimibe monotherapy group compared to the placebo group; • Percent change from Day 1 to Day 85 in ApoB for the ezetimibe monotherapy group compared to the placebo group; • Percent change from Day 1 to Day 85 in LDL-C, as measured by preparative ultracentrifugation, also referred to as beta quantification, for the combination therapy group compared to the obicetrapib monotherapy group; and • Percent change from Day 1 to Day 85 in ApoB for the combination therapy group compared to the obicetrapib monotherapy group.;Timepoint(s) of evaluation of this end point: Screening, Day 1, Day 29, day 57 and Day 85 | — |
Countries
Netherlands
Contacts
Public ContactClinical Operations
NewAmsterdam Pharma BV
Outcome results
None listed