Mixed DyslipidemiaPhase 3MEDICINCT07614958
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
A Phase 3 study of Mixed Dyslipidemia and Hypercholesterolaemia, run by A. Menarini International Licensing S.A. at 1 site in United Kingdom.
Trial summary
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Dyslipidemia, Hypercholesterolaemia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2026to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are male or female and ≥18 years of age at Screening (Visit 1);
- Females may be enrolled if all 3 of the following criteria are met:
- Are not pregnant;
- Are not breastfeeding; and
- Do not plan to become pregnant during the study.
- Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
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- 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);
- 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);
- Have fasting TGs <500 mg/dL (<5.7 mmol/L) at Screening (Visit 1); and
- Have an eGFR ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
Who cannot join
- Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
- Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
- Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
- Have uncontrolled severe hypertension;
- 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;
- Have active liver disease;
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- Have HbA1c ≥8.0% (≥0.080 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
- 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);
- Have history of full statin intolerance;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
FutureMeds North Tees
Stockton-on-Tees, TS19
About this study
Official title: A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.
The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks
- Conditions
- Mixed Dyslipidemia, Hypercholesterolaemia
- Being tested
- Obicetrapib 10 mg/Bempedoic Acid Placebo, Bempedoic Acid 180mg/Placebo Obicetrapib
- Keywords
- Bempedoic Acid, Obicetrapib, Hypercholesterolaemia, Mixed Dyslipidemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obicetrapib 10 mg/Bempedoic Acid PlaceboDrug
Orally, Once Daily
Bempedoic Acid 180mg/Placebo ObicetrapibDrug
Orally, Once Daily
| Study group | Role | What they receive |
|---|---|---|
| Obicetrapib | Experimental | Not described Receives: Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo |
| Bempedoic Acid | Active comparator | Not described Receives: Drug: Bempedoic Acid 180mg/Placebo Obicetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (6)
Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group
Measured: 84 days
Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;
Measured: 84 days
Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;
Measured: 84 days
Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;
Measured: 84 days
Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group;
Measured: 84 days
Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start6 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization: Participants are randomized 1:1 to receive either: Group 1: Obicetrapib + Placebo (matching BPA) Group 2: Bempedoic Acid + Placebo (matching OBI)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A. Menarini International Licensing S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614958
- Sponsor's protocol ID
- AMIL/25/Obi-Dys/001
- Other IDs
- 2025-524265-24-00, 2025
- Acronym
- MEDICI
- Status last verified
- Apr 2026
- First submitted
- 22 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Comparative Study of Obicetrapib and Bempedoic Acid on Top of Maximally Tolerated Lipid-Lowering Therapy in Patients With Dyslipidemia at High to Very High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT07614958
- Acronym / sponsor ID
- MEDICI / AMIL/25/Obi-Dys/001
- Conditions
- Mixed Dyslipidemia, Hypercholesterolaemia
- Keywords
- Bempedoic Acid, Obicetrapib, Hypercholesterolaemia, Mixed Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- A. Menarini International Licensing S.A.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk. Participants must have elevated low density lipoprotein cholesterol (LDL-C) levels despite receiving maximally tolerated lipid lowering therapy.
The primary objective is to compare the LDL-C lowering effect of OBI (a CETP inhibitor) against BPA at 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization: Participants are randomized 1:1 to receive either: Group 1: Obicetrapib + Placebo (matching BPA) Group 2: Bempedoic Acid + Placebo (matching OBI)
| Arm | Type | Receives |
|---|---|---|
| Obicetrapib | Experimental | Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo |
| Bempedoic Acid | Active comparator | Drug: Bempedoic Acid 180mg/Placebo Obicetrapib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Are male or female and ≥18 years of age at Screening (Visit 1);
- Females may be enrolled if all 3 of the following criteria are met:
- Have primary non-familial hypercholesterolemia or mixed dyslipidemia and are at high to very high CV risk;
- 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);
- 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);
Key exclusion criteria (9 listed)
- Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
- Have been hospitalized for HF, with HF as the primary cause of the hospitalization, within 5 years prior to Screening (Visit 1);
- Have had any of the following clinical events within 3 months prior to Screening (Visit 1): MI; Stroke; Non-elective coronary revascularization; and/or Hospitalization for unstable angina and/or chest pain.
- Have uncontrolled severe hypertension;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obicetrapib 10 mg/Bempedoic Acid PlaceboOrally, Once Daily | Drug | Obicetrapib |
| Bempedoic Acid 180mg/Placebo ObicetrapibOrally, Once Daily | Drug | Bempedoic Acid |
Primary outcome
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.
Time frame: 84 days
6 secondary outcomes
Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group
Time frame: 84 days
Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;
Time frame: 84 days
Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;
Time frame: 84 days
Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;
Time frame: 84 days
Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group;
Time frame: 84 days
Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group.
Time frame: 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mixed Dyslipidemia
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
RecruitingPhase 1/2
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Hyperlipidemia; Mixed
Active, not recruitingObservational study
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemiia, Mixed Dyslipidemia
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruiting
Randomized Controlled Trial of Alert-Based Computerized Decision Support for Optimizing Low-Density Lipoprotein Management
Hyperlipemia, Mixed, ASCVD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Mixed Dyslipidemia and Hypercholesterolaemia, run by A. Menarini International Licensing S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Conte, Medical Doctor (+352 26497650, aconte@menarini.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.