A Study to Evaluate the Effect of Obicetrapib in Combination with Ezetimibe in Mild Dyslipidemia

Phase 1

• Conditions: mild dyslipidemia; MedDRA version: 20.1Level: LLTClassification code 10020049Term: High cholesterolSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-004935-22-NL
• Lead Sponsor: ewAmsterdam Pharma BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-08
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 152

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;
oWomen 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;
oWomen 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 <55 years of age;
oWomen of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. Men whose partners are of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of <1 used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap) or a sterile sexual partner;

3.Fasting LDL-C levels >2.5 mmol/L and <4.5 mmol/L and TG levels <4.5 mmol/L (Visit 1); and

4.Willingness to maintain a stable diet and physical activity level throughout the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 <60 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
10.Hepatic dysfunction as evidenced by any laboratory abnormality as follows: gamma-glutamyl transferase, alanine aminotransferase, or aspartate aminotransferase >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified