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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

A. Menarini International Licensing S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

21 May 2026 → ongoing

Decision date (initial)

2026-05-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

A. Menarini International Licensing S.A (AMIL)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others

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

Secondary objectives 8

1. 1. To evaluate the effect of OBI compared to BPA on non-HDL-C at Day 84;
2. 2. To evaluate the effect of OBI compared to BPA on HDL-C at Day 84
3. 3. To evaluate the effect of OBI compared to BPA on ApoA1 at Day 84
4. 4. To evaluate the effect of OBI compared to BPA on Lp(a) at Day 84;
5. 5. To evaluate the effect of OBI compared to BPA on ApoB at Day 84
6. 6. To evaluate the effect of OBI compared to BPA on TGs at Day 84
7. 7. To evaluate the overall proportion of participants achieving CV risk-based LDL-C goals at Day 84; and
8. 8. To evaluate the safety and tolerability profile of OBI and BPA in a representative population of adult males and females with primary non-familial hypercholesterolemia at high to very high CV risk of all ages, assessed by AEs, ESIs, and clinical laboratory values.

Conditions and MedDRA coding

Dyslipidemia at High to Very High Cardiovascular Risk

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 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. 2. Are male or female and ≥18 years of age at Screening (Visit 1)
3. 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. 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. 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. 6. Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk
7. 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. 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. 9. Have fasting TGs <500 mg/dL (<5.7 mmol/L) at Screening (Visit 1)
10. 10. Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).

Exclusion criteria 20

1. 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%;
2. 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);
3. 11. Have a known history of alcohol and/or drug abuse within 5 years prior to randomization (Visit 2)
4. 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
5. 13. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1);
6. 2. Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
7. 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.
8. 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;
9. 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
10. 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);
11. 7. Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
12. 8. Have thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);
13. 9. Have creatine kinase (CK) >3 × ULN at Screening (Visit 1);
14. 14. Have history of full statin intolerance;
15. 15. Are treated with simvastatin, pravastatin, pitavastatin, or inclisiran;
16. 16. Have planned use of other investigational products or devices during the course of the study
17. 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. 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. 19. Have any participant condition that, according to the Investigator, could interfere with the conduct of the study
20. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. The primary efficacy endpoint is the percentage change from baseline to Day 84 in LDL-C in the OBI group compared to the BPA group.

Secondary endpoints 8

1. 1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group
2. 2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group
3. 3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group
4. 4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;
5. 5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and
6. 6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group
7. 7. Overall proportion of participants in the OBI group compared to the BPA group achieving their CV risk-based LDL-C goals, defined as: o High CV risk participants at Day 84 who achieved LDL-C <70 mg/dL (<1.8 mmol/L); and o Very high CV risk participants at Day 84 who achieved LDL-C <55 mg/dL (<1.4 mmol/L).
8. 8. Safety and tolerability profile of OBI and BPA assessed by AEs, ESIs, physical examinations, vital signs, and clinical laboratory values.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

A. Menarini International Licensing S.A.

Sponsor organisation

A. Menarini International Licensing S.A.

Address

12c Impasse Drosbach

City

Luxemburg

Postcode

1882

Country

Luxembourg

Scientific contact point

Organisation

A. Menarini International Licensing S.A.

Contact name

Paolo Fabrizzi

Public contact point

Organisation

A. Menarini International Licensing S.A.

Contact name

Paolo Fabrizzi

Third parties 4

Locations

7 EU/EEA countries · 46 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications