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

Last updated: May 8, 2025
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) Anuntreated LDL-C value must be available within 5 years prior to the start of thetriple therapy. Untreated means that the LDL-C value is not influenced by any lipidlowering therapy at the time of blood collection. Time window for not being treatedas specified in the protocol.

  2. No contraindications exist according to the SmPC of bempedoic acid, the respectivestatin and ezetimibe as per physicians' assessment 9) No concurrent participation inan interventional study (simultaneous participation in other non-interventionalstudies 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

  • Kardiologische Gemeinschaftspraxis am Park Sanssouci

    Potsdam, 14469
    Germany

    Active - Recruiting

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