ClinicalTrials.gg
Sign In
RecruitingNCT07614958MEDICIUpdated Jun 9, 2026

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 interventional study of Obicetrapib 10 mg/Bempedoic Acid Placebo and Bempedoic Acid 180mg/Placebo Obicetrapib in Mixed Dyslipidemia and Hypercholesterolaemia, sponsored by A. Menarini International Licensing S.A.. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by A. Menarini International Licensing S.A. (part of Menarini Group) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Mixed Dyslipidemia
  • Hypercholesterolaemia

Keywords

  • Bempedoic Acid
  • Obicetrapib
  • Hypercholesterolaemia
  • Mixed Dyslipidemia
03

In context

Hypercholesterolemia

1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.

This study's planned enrollment of 426 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

This is the only study on the registry with A. Menarini International Licensing S.A. as lead sponsor.

Browse A. Menarini International Licensing S.A. studies →All Menarini Group studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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:

    1. Are not pregnant;
    2. Are not breastfeeding; and
    3. 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;
  • 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 ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).

Exclusion criteria

Exclusion Criteria:

  • Have current or any previous history of class III or IV HF or \<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;
  • Have ≥8.0% (≥0.080 fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
  • Have a history of a 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;
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
426 participants (estimated)

Study arms

  • Experimental
    Obicetrapib

    Drug: Obicetrapib 10 mg/Bempedoic Acid Placebo

  • Active comparator
    Bempedoic Acid

    Drug: Bempedoic Acid 180mg/Placebo Obicetrapib

Interventions

  • DrugObicetrapib 10 mg/Bempedoic Acid Placebo

    Orally, Once Daily

  • DrugBempedoic Acid 180mg/Placebo Obicetrapib

    Orally, Once Daily

06

What researchers measure

Primary outcomes

  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.

    Time frame: 84 days

Secondary outcomes

  1. Percentage change from baseline to Day 84 in non-HDL-C in the OBI group compared to the BPA group

    Time frame: 84 days

  2. Percentage change from baseline to Day 84 in HDL-C in the OBI group compared to the BPA group;

    Time frame: 84 days

  3. Percentage change from baseline to Day 84 in ApoA1 in the OBI group compared to the BPA group;

    Time frame: 84 days

  4. Percentage change from baseline to Day 84 in Lp(a) in the OBI group compared to the BPA group;

    Time frame: 84 days

  5. Percentage change from baseline to Day 84 in ApoB in the OBI group compared to the BPA group;

    Time frame: 84 days

  6. Percentage change from baseline to Day 84 in TGs in the OBI group compared to the BPA group.

    Time frame: 84 days

07

Study locations

1 of 1 sites recruiting
  • FutureMeds North Tees
    Stockton-on-Tees, TS19, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jan 2027, 8 months after the start.

Of 122 industry-sponsored phase 3 interventional studies under Hypercholesterolemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 8 months is below that.

Counting every sponsor, half of 125 studies reached it within 18 months; a quarter within 10 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2026
First posted
May 29, 2026
StartActual
May 6, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07614958
Lead sponsor
A. Menarini International Licensing S.A.
Collaborators
Medpace, Inc.
Responsible party
Sponsor
First posted
May 29, 2026
Start date
May 6, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jun 9, 2026

Study contacts

Andrea Conte, Medical Doctor
Contact
aconte@menarini.lu
+352 26497650

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercholesterolemia →

Start the discussion