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Compares treatment options for Mixed Dyslipidemia
Official title Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
ClinicalTrials.gov ID: NCT07614958
What this study is testing
- What it's testing
- This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are male or female and ≥18 years of age at Screening (Visit 1);
- Females may be enrolled if all 3 of the following criteria are met:
- Are not pregnant;
- Are not breastfeeding; and
- Do not plan to become pregnant during the study.
You likely can't join if
- Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction \<30%;
- Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
- Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization...
- Have uncontrolled severe hypertension;
- Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid...
- Have active liver disease;
See the full eligibility criteria
- Are male or female and ≥18 years of age at Screening (Visit 1);
- Females may be enrolled if all 3 of the following criteria are met:
- Are not pregnant;
- Are not breastfeeding; and
- Do not plan to become pregnant during the study.
- Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
- Are on stable maximally tolerated lipid-modifying therapy for at least 8 weeks prior to Screening (Visit 1) as an adjunct to a lipid-lowering diet and lifestyle modifications, defined as a maximum tolerated statin dose...
- Have a fasting serum LDL-C at Screening (Visit 1) of ≥70 mg/dL (1.81 mmol/L) and \<130 mg/dL (3.37 mmol/L);
- Have fasting TGs \<500 mg/dL (\<5.7 mmol/L) at Screening (Visit 1); and
- Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
- Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction \<30%;
- Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
- Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
- Have uncontrolled severe hypertension;
- Have a formal diagnosis of definite familial hypercholesterolemia (either homozygous or heterozygous) either through genetic testing on Dutch Lipid Network criteria, Simon Broome, or MedPed;
- Have active liver disease;
- Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
- Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Screening (Visit 1);
- Have history of full statin intolerance;
The study team makes the final eligibility decision.
Where it's taking place
- Stockton-on-Tees, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockton-on-Tees, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.