Clinical trial • Phase III • Cardiology

OBICETRAPIB for Dyslipidemia | Primary non-familial hypercholesterolemia | Mixed dyslipidemia

Phase III trial of OBICETRAPIB for Dyslipidemia | Primary non-familial hypercholesterolemia | Mixed dyslipidemia.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Dyslipidemia | Primary non-familial hypercholesterolemia | Mixed dyslipidemia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-01-2026
First CTIS Authorization Date
11-05-2026

Trial design

Randomised, comparator arm: nilemdo 180 mg film-coated tablets (active substance: bempedoic acid) — marketing authorisation eu/1/20/1425/002 is listed; obicetrapib is the test product (10 mg tablet listed as max daily dose). matching placebos for both obi and bpa are used. routes: oral. (doses: obicetrapib max daily dose 10 mg; bempedoic acid product listed as 180 mg film-coated tablets.)-controlled Phase III trial in Czechia, Germany, Italy and others.

Randomised
Yes
Comparator
Comparator arm: Nilemdo 180 mg film-coated tablets (active substance: bempedoic acid) — marketing authorisation EU/1/20/1425/002 is listed; Obicetrapib is the test product (10 mg tablet listed as max daily dose). Matching placebos for both OBI and BPA are used. Routes: oral. (Doses: Obicetrapib max daily dose 10 mg; Bempedoic acid product listed as 180 mg film-coated tablets.)
Target Sample Size
88
Trial Duration For Participant
84

Eligibility

Recruits 88 Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be able and willing to provide written informed consent prior to any study procedures (participants must be ≥18 years). Multiple country-specific subject information and informed consent forms are provided; no children/minors are included and no assent procedures are specified..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be able and willing to provide written informed consent prior to any study procedures (participants must be ≥18 years). Multiple country-specific subject information and informed consent forms are provided; no children/minors are included and no assent procedures are specified.

Inclusion criteria

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

Exclusion criteria

  • {"criterion_text":"- 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%;\n- 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);\n- 7. Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);\n- 8. Have thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);\n- 9. Have creatine kinase (CK) >3 × ULN at Screening (Visit 1);\n- 14. Have history of full statin intolerance;\n- 15. Are treated with simvastatin, pravastatin, pitavastatin, or inclisiran;\n- 16. Have planned use of other investigational products or devices during the course of the study\n- 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)\n- 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)\n- 19. Have any participant condition that, according to the Investigator, could interfere with the conduct of the study\n- 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);\n- 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.\n- 11. Have a known history of alcohol and/or drug abuse within 5 years prior to randomization (Visit 2)\n- 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\n- 13. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1);\n- 2. Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);\n- 3. Have had any of the following clinical events within 3 months prior to Screening (Visit 1): o\tMI; o Stroke; o Non-elective coronary revascularization; and/or o Hospitalization for unstable angina and/or chest pain.\n- 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;\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Percentage change from baseline to Day 84 in LDL-C (comparing OBI vs BPA); measured as change in LDL-C concentration from baseline to Day 84 and expressed as percentage change."}

Secondary endpoints

  • {"endpoint_text":"- 1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group\n- 2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group\n- 3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group\n- 4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;\n- 5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group; and\n- 6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group\n- 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\tHigh CV risk participants at Day 84 who achieved LDL-C <70 mg/dL (<1.8 mmol/L); and o\tVery high CV risk participants at Day 84 who achieved LDL-C <55 mg/dL (<1.4 mmol/L).\n- 8. Safety and tolerability profile of OBI and BPA assessed by AEs, ESIs, physical examinations, vital signs, and clinical laboratory values.","definition_or_measurement_approach":"Most secondary endpoints are percentage changes from baseline to Day 84 in specified lipid parameters (non-HDL-C, HDL-C, ApoA1, Lp(a), ApoB, TGs). Proportion achieving LDL-C thresholds defined by CV risk at Day 84. Safety/tolerability assessed by adverse events (AEs), events of special interest (ESIs), physical exams, vital signs and laboratory values."}

Recruitment

Planned Sample Size
88
Recruitment Window Months
8
Consent Approach
Written informed consent is required from each participant prior to any study-related procedures. Participants must be ≥18 years and provide consent themselves. Country-specific subject information and informed consent forms are provided (documents available in English, Czech, German, Italian, Spanish, Slovak, Dutch, Polish as per submitted ICF/synopsis documents). No assent procedures for minors are provided because minors are excluded.

Geography

Total Number Of Sites
48
Total Number Of Participants
338

Czechia

Earliest CTIS Part Ii Submission Date
22-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
20
Number Of Sites
7
Number Of Participants
38

Sites

Site Name
MUDr. Nina Zemkova s.r.o.
Department Name
Interní ambulance
Contact Person Name
Stanislav Zemek
Contact Person Email
info@ambulanceuh.cz
Site Name
Kardiologicka ambulance Brno s.r.o.
Contact Person Name
Jiří Pařenica
Contact Person Email
jiri.parenica@atlas.cz
Site Name
Unilabs Diagnostics k.s.
Department Name
Lipidová poradna Teplice
Contact Person Name
Petr Reichert
Contact Person Email
klienti@unilabs.com
Site Name
CTC Hodonin s.r.o.
Contact Person Name
Jiří Matuška
Contact Person Email
jiri.matuska@matmed.cz
Site Name
Medicus Services s.r.o.
Department Name
Kardiologická a interní ambulance
Contact Person Name
Jiří Krupička
Contact Person Email
kardiologie.brandys@seznam.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Kardiologické oddělení
Contact Person Name
Kateřina Řehoušková
Contact Person Email
rehouskova.katerina@nemcb.cz
Site Name
Kollarova 4338/9 (address entry)

Germany

Earliest CTIS Part Ii Submission Date
28-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
15
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
Medizentrum Essen Borbeck
Department Name
Medizentrum Essen Borbeck
Contact Person Name
Axel Schäfer
Contact Person Email
axel.schaefer@mzeb.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Cardiology
Contact Person Name
Irina Müller-Kozarez
Site Name
ZKS Dr. Jörg Lüdemann
Department Name
ZKS Dr. Jörg Lüdemann
Contact Person Name
Jörg Lüdemann
Contact Person Email
jl@diabetes-falkensee.de
Site Name
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Department Name
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Contact Person Name
Klaus Busch
Contact Person Email
kontakt@diabeteszentrum-doc.de
Site Name
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf
Department Name
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf
Contact Person Name
Josef Großkopf

Italy

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
101
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medicina interna cardiovascolare
Contact Person Name
Arrigo Francesco Giuseppe Cicero
Contact Person Email
arrigo.cicero@unibo.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Cardiothoracovascular
Contact Person Name
Antonia Alberti
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Diabetes and Cardiometabolic Prevention Unit
Contact Person Name
Manfredi Rizzo
Contact Person Email
manfredi.rizzo@unipa.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Internal Medicine
Contact Person Name
Fabio Nascimbeni
Contact Person Email
ricercainnovazione@aou.mo.it
Site Name
Azienda Ospedaliera Di Perugia
Department Name
Internal Medicine
Contact Person Name
Matteo Pirro
Contact Person Email
dipartimento.med@unipg.it
Site Name
Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta
Department Name
Cardiovascular
Contact Person Name
Paolo Calabrò
Contact Person Email
paolo.calabro@unicampania.it
Site Name
IRCCS Azienda Ospedaliera Metropolitana
Department Name
Internal Medicine
Contact Person Name
Livia Pisciotta
Contact Person Email
livia.pisicotta@unige.it
Site Name
Ente Ecclesiastico Ospedale Generale Regionale Miulli
Department Name
Cardiology
Contact Person Name
Federica Troisi
Contact Person Email
Federica.troisi@libero.it

Spain

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
101
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
Futuremeds Spain S.L. (Sevilla)
Department Name
Cardiologia
Contact Person Name
Javier Quintana Figueroa
Contact Person Email
javier.quintana@futuremeds.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiologia
Contact Person Name
Clara Bonanad Lozano
Contact Person Email
clarabonanad@gmail.com
Site Name
Futuremeds Spain S.L. (Madrid)
Department Name
Medicina de familia
Contact Person Name
Maria Antonia Billon Laa
Contact Person Email
maria.billon@futuremeds.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiologia
Contact Person Name
Domingo Andrés Pascual Figal
Contact Person Email
dpascual@um.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medicina Interna
Contact Person Name
Olivia Sanchez Sanchez

Netherlands

Earliest CTIS Part Ii Submission Date
23-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
20
Number Of Sites
4
Number Of Participants
54

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Cardiology
Contact Person Name
Saloua El Messaoudi
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Internal Medicine
Contact Person Name
Simone Hartong
Contact Person Email
s.c.c.hartong@asz.nl
Site Name
Laurentius Ziekenhuis Roermond
Department Name
Cardiology
Contact Person Name
Peter Luyten
Contact Person Email
p.luyten@lzr.nl
Site Name
Bravis Ziekenhuis
Department Name
Internal Medicine
Contact Person Name
Mustafa Ezzahti
Contact Person Email
poli.endocrinologie@bravis.nl

Poland

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
32
Number Of Sites
11
Number Of Participants
93

Sites

Site Name
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
Contact Person Name
Włodzimierz Kuś
Contact Person Email
wlodzimierz.kus@wp.pl
Site Name
Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j.
Contact Person Name
Jarosław Trębacz
Contact Person Email
jartrebacz@gmail.com
Site Name
Velocity Nova Sp. z o.o.
Contact Person Name
Grzegorz Mizerski
Contact Person Email
gmizerski@velocityclinical.com
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Contact Person Name
Łukasz Siudak
Contact Person Email
lukasz.tr.s@gmail.com
Site Name
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
Contact Person Name
Michał Miszczak
Contact Person Email
michal.miszczak.bk@1wszk.pl
Site Name
Centrum Medyczne Intercor Sp. z o.o.
Contact Person Name
Grzegorz Grześk
Contact Person Email
grzegorz.grzesk@interia.pl
Site Name
Indywidualna Specjalistyczna Praktyka Lekarska W Dziedzinie Kardiologii Lek Med. Krzysztof Cymerman
Contact Person Name
Krzysztof Cymerman
Contact Person Email
cym@interia.eu
Site Name
Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska
Contact Person Name
Ewa Mirek-Bryniarska
Contact Person Email
ebryniarska@poczta.fm
Site Name
Clinical Best Solutions Sp. z o.o. S.K. (Warsaw)
Contact Person Name
Joanna Niegowska
Contact Person Email
jniegowska@onet.pl
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Contact Person Name
Jacek Kiełtucki
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Maciej Żechowicz

Slovakia

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
11
Number Of Sites
8
Number Of Participants
70

Sites

Site Name
Kardio 1 s.r.o.
Department Name
Kardiologická a interná ambulancia
Contact Person Name
Ján Nociar
Contact Person Email
nociar@avexis.sk
Site Name
IN DIA s.r.o.
Department Name
Ambulancia diabetológie a porúch látkovej premeny a výživy
Contact Person Name
Lívia Tomášová
Contact Person Email
liviatomasova66@gmail.com
Site Name
Cardio D&R s.r.o. Kosice
Department Name
Kardiologická ambulancia
Contact Person Name
Ján Fedačko
Contact Person Email
janfedacko@hotmail.com
Site Name
Medivasa s.r.o.
Department Name
Angiologická ambulancia
Contact Person Name
Viliam Bugáň
Contact Person Email
bugan@medivasa.sk
Site Name
Medical group Kosice s.r.o.
Department Name
Kardiologická a Interná ambulancia
Contact Person Name
Ivan Majerčák
Contact Person Email
majercak@medicalgroup.sk
Site Name
Stredoslovensky ustav srdcovych a cievnych chorob a.s.
Department Name
Oddelenie akútnej kardiológie
Contact Person Name
Martin Hudec
Contact Person Email
hudecmt@hotmail.com
Site Name
Areteus s.r.o.
Department Name
Ambulancia diabetológie a porúch látkovej premeny a výživy
Contact Person Name
Daša Skripová
Contact Person Email
dasa.skripova@gmail.com
Site Name
Mudronova 29 (address entry)

Sponsor

Primary sponsor

Full Name
A. Menarini International Licensing S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Luxembourg

Contract research organisations

Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties codes: 14
Name
Medpace Finland Oy
Responsibilities
sponsorDuties codes: 1,10,11,12,13,3,4,5,6,7,8

Third parties

  • {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Novasco","duties_or_roles":"Patient reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"codes:1,10,11,12,13,3,4,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Obicetrapib
Active Substance
OBICETRAPIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Starting Dose
10 mg
Dose Levels
10 mg
Maximum Dose
10 mg
Investigational Product Name
Nilemdo 180 mg film-coated tablets
Active Substance
BEMPEDOIC ACID
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Marketing authorisation EU/1/20/1425/002
Starting Dose
180 mg
Dose Levels
180 mg
Maximum Dose
180 mg
Investigational Product Name
Bempedoic acid matching placebo
Modality
Other
Investigational Product Name
Obicetrapib matching placebo
Modality
Other

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