Authorised Therapeutic confirmatory (Phase III) Dyslipidemia at High to Very High Cardiovascular Risk

Obicetrapib Versus Bempedoic Acid to Treat Dyslipidemia in Patients at High to Very High Cardiovascular Risk

EU CTIS ID: 2025-524265-24-00

What this study is testing

Evaluate the efficacy of OBI compared to BPA in reducing LDL-C levels at Day 84.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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
10. Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
2. Are male or female and ≥18 years of age at Screening (Visit 1)
3. Female participants of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile (hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
4. Female participants of childbearing potential will be included if they are either sexually inactive (abstinent) for 90 days prior to the first dose of study drug with planned continued abstinence throughout study participation or are using one of the highly effective birth control methods (ie, <1% failure rate when used consistently and correctly)
5. Male participants who are fertile with female partners of childbearing potential must agree to use highly effective methods of birth control from Screening (Visit 1) until 35 days after the last dose of study drug. A man is considered fertile after puberty unless permanently sterile by bilateral vasectomy

You likely can't join if

1. Have current or any previous history of New York Heart Association class III or IV heart failure (HF) or left ventricular ejection fraction <30%;
6. Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1);
7. Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
8. Have thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);
9. Have creatine kinase (CK) >3 × ULN at Screening (Visit 1);
14. Have history of full statin intolerance;

See the full eligibility criteria

Who can join

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
10. Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
2. Are male or female and ≥18 years of age at Screening (Visit 1)
3. Female participants of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile (hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
4. Female participants of childbearing potential will be included if they are either sexually inactive (abstinent) for 90 days prior to the first dose of study drug with planned continued abstinence throughout study participation or are using one of the highly effective birth control methods (ie, <1% failure rate when used consistently and correctly)
5. Male participants who are fertile with female partners of childbearing potential must agree to use highly effective methods of birth control from Screening (Visit 1) until 35 days after the last dose of study drug. A man is considered fertile after puberty unless permanently sterile by bilateral vasectomy
6. Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk
7. 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, with or without ezetimibe and/or a monoclonal PCSK9 targeted therapy for at least 4 stable doses prior to Screening (Visit 1).
8. 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);
9. Have fasting TGs <500 mg/dL (<5.7 mmol/L) at Screening (Visit 1)

What rules you out

1. Have current or any previous history of New York Heart Association class III or IV heart failure (HF) or left ventricular ejection fraction <30%;
6. Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1);
7. Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
8. Have thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);
9. Have creatine kinase (CK) >3 × ULN at Screening (Visit 1);
14. Have history of full statin intolerance;
15. Are treated with simvastatin, pravastatin, pitavastatin, or inclisiran;
16. Have planned use of other investigational products or devices during the course of the study
17. Have participated in any clinical study evaluating OBI and/or have previously been treated with BPA (either in the context of a clinical study or in the routine standard practice)
18. Have a known allergy or hypersensitivity to either OBI or BPA, or any of their excipients, or a specific intolerance to either’s excipients (eg, rare, inherited conditions such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption)
19. Have any participant condition that, according to the Investigator, could interfere with the conduct of the study
10. 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);
20. Are committed to an institution by virtue of an order issued either by the judicial or administrative authorities or who are in a dependent relationship with the Sponsor or Investigator.
11. Have a known history of alcohol and/or drug abuse within 5 years prior to randomization (Visit 2)
12. Have received treatment with other investigational products or devices within 30 days of Screening (Visit 1) 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 (Visit 1);
2. Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
3. Have had any of the following clinical events within 3 months prior to Screening (Visit 1): o MI; o Stroke; o Non-elective coronary revascularization; and/or o Hospitalization for unstable angina and/or chest pain.
4. Have uncontrolled severe hypertension, defined as either systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg taken as the average of triplicate measurements at Screening (Visit 1). One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized;
5. 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

The study team makes the final eligibility decision.

Where it's taking place

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.