A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Last updated: March 2, 2026
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Treatment

Rosuvastatin

Atorvastatin

Bempedoic acid

Clinical Study ID

NCT06686615
DSE-BMP-01-24-EU
  • Ages > 18
  • All Genders

Study Summary

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Written informed consent to participate

  2. At least 18 years of age

  3. High and very high risk patients as assessed by the physician suffering fromdocumented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoicacid treatment

  4. Patients treated with:

  • bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,

  • bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,

  • bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe

  • initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatinsimultaneously

  1. Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.

  2. No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy > 1 -year

Exclusion

Key Exclusion Criteria:

  1. Patients who have received PCSK9i monoclonal antibody treatment in the last 3 monthsbefore the start of the triple therapy exposure

  2. Patients who have ever received PCSK9i-siRNA treatment

Study Design

Total Participants: 2000
Treatment Group(s): 4
Primary Treatment: Rosuvastatin
Phase:
Study Start date:
February 12, 2025
Estimated Completion Date:
January 31, 2028

Study Description

The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a real-world clinical setting. No drug will be administered during this observational study.

The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks.

The secondary objectives will include the following:

  • Goal attainment at 8 weeks and 1 year after start of triple therapy

  • Effectiveness of triple therapy in terms of LDL-C reduction at 1 year

  • Effectiveness of adding bempedoic acid to statin and ezetimbe at 8 weeks and 1 year

  • Effectiveness of adding bempedoic acid/ezetimibe FDC to statin in terms of LDL-C reduction at 8 weeks and 1 year

  • Changes in laboratory values at 8 weeks and 1 year after start of triple therapy

  • Adherence to triple therapy treatment

  • Collection and recording of all adverse events occurred since initiation of triple therapy

  • MACE-3 and MACE-4 (consisting of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only)) during the year of follow-up

  • Treatment changes at LMT initiation and at triple therapy initiation

  • Treatment pathway from triple therapy initiation to 1-year after start of triple therapy

Connect with a study center

  • Innere Medizin

    Braunau am Inn, 5280
    Austria

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    Braunau am Inn 2781520, 5280
    Austria

    Site Not Available

  • Innere Medizin 1

    Feldkirch, 6800
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    Site Not Available

  • Innere Medizin 1

    Feldkirch 2779674, 6800
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    Site Not Available

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    Graz, 8036
    Austria

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    Graz, 8036
    Austria

    Site Not Available

  • Uniklinik Graz, Endokrinologie und Diabetes

    Graz 2778067, 8036
    Austria

    Site Not Available

  • Uniklinik Graz, Kardiologie

    Graz 2778067, 8036
    Austria

    Site Not Available

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    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Innere Medizin 3 - Kardiologie

    Innsbruck 2775220, 6020
    Austria

    Site Not Available

  • Klinikum Wels-Grieskirchen GmbH+B18

    Kepler Universitätsklinikum Gmb+, 4600
    Austria

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  • Innere Medizin

    Klagenfurt, 9020
    Austria

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  • Innere Medizin

    Klagenfurt 2774326, 9020
    Austria

    Site Not Available

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    Linz, 4020
    Austria

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    Linz, 4040
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    Linz, 4021
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    Linz 2772400, 4020
    Austria

    Site Not Available

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    Linz 2772400, 4040
    Austria

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    Dresden, 01159
    Germany

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    Dresden 2935022, 01796
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    Goslar, 38640
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    Goslar 2918840, 38640
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    Greiz, 07973
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  • Praxis

    Greiz, 07973
    Germany

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  • IHRE Klinik

    Greiz 2917737, 07973
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    Greiz 2917737, 07973
    Germany

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    Gräfenhainichen, 06773
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    Germany

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    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
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    Heidelberg, 69115
    Germany

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  • Uni-Klinik Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

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    Heidelberg 2907911, 69115
    Germany

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  • Uni-Klinik Heidelberg

    Heidelberg 2907911, 69120
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    Kaiserslautern, 67655
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  • Kardiopraxis

    Kaiserslautern 2894003, 67655
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    Koblenz, 56073
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    Site Not Available

  • GK Mittelrhein

    Koblenz 2886946, 56073
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    Site Not Available

  • Klinikum Konstanz

    Konstanz, 78464
    Germany

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  • Klinikum Konstanz

    Konstanz 2885679, 78464
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    Leipzig, 04103
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  • Universitätsklinikum Leipzig

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    Site Not Available

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    Lichtenstein, 09350
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    Lichtenstein 2878037, 09350
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    Site Not Available

  • Policlinico Federico II

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Policlinico P. Giaccone

    Palermo, 90127
    Italy

    Active - Recruiting

  • Policlinico P. Giaccone

    Palermo 2523920, 90127
    Italy

    Site Not Available

  • ICS Maugeri

    Pavi, 27100
    Italy

    Active - Recruiting

  • S. Maria della Misericordia

    Perugia, 06129
    Italy

    Active - Recruiting

  • S. Maria della Misericordia

    Perugia 3171180, 06129
    Italy

    Site Not Available

  • Presidio Ospedaliero

    Pescara, 65124
    Italy

    Active - Recruiting

  • Ospedale PederzoliItlit

    Peschiera, 37019
    Italy

    Active - Recruiting

  • Ospedale PederzoliItlit

    Peschiera 8959637, 37019
    Italy

    Site Not Available

  • Cisanello

    Pisa, 56124
    Italy

    Active - Recruiting

  • Cisanello

    Pisa 3170647, 56124
    Italy

    Site Not Available

  • Osp. Santa Maria delle Croci

    Ravenna, 48121
    Italy

    Site Not Available

  • Osp. Santa Maria delle Croci

    Ravenna 3169561, 48121
    Italy

    Site Not Available

  • Osp infermi di rivoli

    Rivoli, 10098
    Italy

    Active - Recruiting

  • Osp infermi di rivoli

    Rivoli 3169231, 10098
    Italy

    Site Not Available

  • Ospedale Pertini

    Roma, 00157
    Italy

    Active - Recruiting

  • Ospedale Sant'Andrea

    Roma, 00189
    Italy

    Active - Recruiting

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Active - Recruiting

  • Ospedale Pertini

    Roma 8957247, 00157
    Italy

    Site Not Available

  • Ospedale Sant'Andrea

    Roma 8957247, 00189
    Italy

    Active - Recruiting

  • Policlinico Tor Vergata

    Roma 8957247, 00133
    Italy

    Site Not Available

  • Policlinico Umberto I

    Rome, 00161
    Italy

    Active - Recruiting

  • Policlinico Umberto I

    Rome 3169070, 00161
    Italy

    Site Not Available

  • Molinette Università to

    Torino, 10126
    Italy

    Active - Recruiting

  • Ospedale Mauriziano

    Torino, 10128
    Italy

    Active - Recruiting

  • Molinette Università to

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Ospedale Mauriziano

    Torino 8980539, 10128
    Italy

    Active - Recruiting

  • Osp. di Cattinara

    Trieste, 34149
    Italy

    Active - Recruiting

  • Osp. di Cattinara

    Trieste 3165185, 34149
    Italy

    Site Not Available

  • Ospedale di Portogruaro

    Venezia, 30026
    Italy

    Active - Recruiting

  • Ospedale di Portogruaro

    Venezia 3175005, 30026
    Italy

    Site Not Available

  • AOUI Verona

    Verona, 37126
    Italy

    Active - Recruiting

  • AOUI Verona

    Verona 3164527, 37126
    Italy

    Site Not Available

  • H. Univers. De Albacete

    Albacete, 02006
    Spain

    Active - Recruiting

  • H. Univers. De Albacete

    Albacete 2522258, 02006
    Spain

    Site Not Available

  • H. General de Elche

    Alicante, 03203
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitario de San Juan

    Alicante, 03550
    Spain

    Active - Recruiting

  • H. General de Elche

    Alicante 2521978, 03203
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante 2521978, 03010
    Spain

    Site Not Available

  • Hospital Universitario de San Juan

    Alicante 2521978, 03550
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo 3109453, 48903
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos 3127461, 09006
    Spain

    Site Not Available

  • H. Punta de Europa

    Cadiz, 11207
    Spain

    Active - Recruiting

  • H. Univ. Puerta del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital Universitario Puerto Real

    Cadiz, 11510
    Spain

    Active - Recruiting

  • H. Punta de Europa

    Cadiz 2520600, 11207
    Spain

    Site Not Available

  • H. Univ. Puerta del Mar

    Cadiz 2520600, 11009
    Spain

    Active - Recruiting

  • Hospital Universitario Puerto Real

    Cadiz 2520600, 11510
    Spain

    Active - Recruiting

  • Sierrallana Hospital

    Cantabria, 39300
    Spain

    Active - Recruiting

  • H. Univ. Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • H. Univ. Reina Sofía

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia / San Sebastian 3110044, 20014
    Spain

    Site Not Available

  • H. Univ. De Cabueñes

    Gijón, 33394
    Spain

    Active - Recruiting

  • H. Univ. De Cabueñes

    Gijón 3121424, 33394
    Spain

    Site Not Available

  • H. Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • H. Virgen de las Nieves

    Granada 2517117, 18014
    Spain

    Site Not Available

  • H. Juan Ramón Jiménez

    Huelva, 21005
    Spain

    Active - Recruiting

  • H. Juan Ramón Jiménez

    Huelva 2516548, 21005
    Spain

    Site Not Available

  • Hospital Universitario Médico-Quirúrgico de Jaén

    Jaén, 23007
    Spain

    Active - Recruiting

  • Hospital Universitario Médico-Quirúrgico de Jaén

    Jaén 2516395, 23007
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canarias Dr. Negrín

    Las Palmas de GC, 35010
    Spain

    Active - Recruiting

  • Hospital de León

    León, 24008
    Spain

    Active - Recruiting

  • Hospital de León

    León 3118532, 24008
    Spain

    Site Not Available

  • Hospital San Pedro

    Logroño, 26006
    Spain

    Active - Recruiting

  • Hospital San Pedro

    Logroño 3118150, 26006
    Spain

    Site Not Available

  • H. Costa del Sol

    Marbella (Málaga), 29603
    Spain

    Active - Recruiting

  • H. Costa del Sol

    Marbella (Málaga) 2514169, 29603
    Spain

    Site Not Available

  • H. Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital General Universitario Reina Sofía

    Murcia, 30003
    Spain

    Site Not Available

  • H. Virgen de la Arrixaca

    Murcia 2513416, 30120
    Spain

    Active - Recruiting

  • Hospital General Universitario Reina Sofía

    Murcia 2513416, 30003
    Spain

    Site Not Available

  • H. Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Serranía de Ronda

    Málaga, 29400
    Spain

    Active - Recruiting

  • H. Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Active - Recruiting

  • Hospital Serranía de Ronda

    Málaga 2514256, 29400
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo 3114711, 33011
    Spain

    Site Not Available

  • Hospital Universitario Son LLatzer

    Palma de Mallorca, 07198
    Spain

    Active - Recruiting

  • Hospital Universitario Son LLatzer

    Palma de Mallorca 2512989, 07198
    Spain

    Site Not Available

  • Clínica Universidad de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona 3114472, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife 2511174, 38320
    Spain

    Site Not Available

  • Hospital de Segovia

    Segovia, 40002
    Spain

    Active - Recruiting

  • Hospital de Segovia

    Segovia 3109256, 40002
    Spain

    Site Not Available

  • Hospital General Universitario de Toledo

    Toledo, 45007
    Spain

    Site Not Available

  • Hospital General Universitario de Toledo

    Toledo 2510409, 45007
    Spain

    Site Not Available

  • Consorcio Hospital General Univ de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • H. Clínico Univ. De Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Consorcio Hospital General Univ de Valencia

    Valencia 2509954, 46014
    Spain

    Site Not Available

  • H. Clínico Univ. De Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Hospital La Fe

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Hospital Universitario de Álava

    Vitoria-Gasteiz, 01009
    Spain

    Active - Recruiting

  • Hospital Universitario de Álava

    Vitoria-Gasteiz 3104499, 01009
    Spain

    Site Not Available

  • Hospital Clinico Universitaro Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Clinico Universitaro Lozano Blesa

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

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