Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD)

JRCT ID: jRCT2031220230

Registered date:30/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dyslipidemia
• Date of first enrollment: 23/08/2022
• Target sample size: 175
• Countries of recruitment: US,Japan,Poland,Japan,Netherlands,Japan,Denmark,Japan,Czech Republic,Japan,China,Japan
• Study type: Interventional
• Intervention(s): One 10 mg tablet of Obicetrapib or Placebo is orally administered QID

Outcome(s)

• Primary Outcome: LDL-C [ Time Frame: Percent change from baseline to Day 84 in LDL-C ] obicetrapib compared to placebo on LDL-C

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Are willing and able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures
2. Are male or female 18 years and more of age at Screening
Females 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
3. Have underlying heterozygous familial hypercholesterolemia (HeFH) and or a history of established ASCVD
4. Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows
- maximally tolerated statin, at a stable dose for at least 8 weeks prior to Screening
- Atorvastatin 10 or 20 mg for non-familial hypercholesterolemia (Japan only)
- Atorvastatin 20 or 40 mg for heterozygous familial hypercholesterolemia (Japan only) or
Rosuvastatin 10 or 20 mg (Japan only)
- Ezetimibe for at least 8 weeks prior to Screening
- Bempedoic acid for at least 8 weeks prior to Screening
- A PCSK-9 targeted therapy for at least 4 stable doses prior to Screening
5. Have a fasting serum LDL-C as follows:
- Fasting serum LDL-C 55 and more and under 100 mg/dL (1.4 and more and under 2.6 mmol/L) OR non-HDL-C 85 mg/dL (2.2 mmol/L) and more to under 130 mg/dL (3.4 mmol/L) with at least 1 of the following risk enhancers at Screening;
- Recent MI (more than 3 and under 12 months prior to Randomization);
- Type 2 diabetes mellitus;
- Current daily cigarette smoking;
- Age of more than 60 years;
- High sensitivity C-reactive protein 2.0 mg/L (19.05 nmol/L) and more at Screening or within 6 months prior to Screening;
- Fasting triglycerides (TG) mor than 150 mg/dL (1.7 mmol/L);
- Fasting lipoprotein (a) more than 30 mg/dL (70 nmol/L); and/or
- Fasting HDL-C under 40 mg/dL (1.0 mmol/L);
OR
- Fasting serum LDL-C 100 mg/dL (2.6 mmol/L) and more OR non-HDL-C 130 mg/dL (3.4 mmol/L) and more
6. Fasting triglyceride (TG) under 500 mg/dL (5.7 mmol/L) at Screening; and
7. Have an estimated glomerular filtration rate (eGFR) 30 mL/min/1.73m2 and more at Screening

Exclude criteria

1. New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction under 30%
2. Hospitalized for heart failure within 5 years prior to Screening
3. Major adverse cardiac event (MACE) within 3 months prior to Screening
4. Uncontrolled severe hypertension, defined as either systolic blood pressure 160 mmHg and more or diastolic blood pressure 100 mmHg and more prior to Randomization
5. Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
6. Active liver disease
7. HbA1c 10% and more or a fasting glucose 270 mg/dL and more at Screening
8. Thyroid-stimulating hormone over 1.5 X upper limit of normal (ULN) at Screening
9. Creatine kinase 3 X upper limit of normal (ULN) at Screening
10. History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization
11. Known history of alcohol and/or drug abuse within 5 years prior to Screening
12. Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer
13. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
14. Planned use of other investigational products or devices during the course of the study;
15. Participated in any clinical trial evaluating obicetrapib; or
16. Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
17. Any condition that, according to the Investigator, could interfere with the conduct of the study
18. Patients who meet the lipid management targets as specified in the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (only for Japan); or
19. Have an existing diagnosis of CETP deficiency (only for Japan)

Related Information

• Primary Sponsor: Toshihiro Hokonohara
• Secondary ID(s): NCT05142722