Back to search results

Study of Obicetrapib for High Cholesterol in Type 2 Diabetes and Metabolic Syndrome

This study is looking at two ways to lower "bad" cholesterol (LDL-C) in people with Type 2 Diabetes (T2DM) and/or Metabolic Syndrome (a group of risk factors for heart disease). You might be eligible if you have high LDL-C, high triglycerides (another type of fat in the blood), and are already taking cholesterol-lowering medication. Researchers are testing obicetrapib 10 mg, either alone or combined with ezetimibe 10 mg, against a placebo (an inactive substance). The main goal is to see how much these treatments lower LDL-C after 84 days compared to placebo. The study aims to enroll 300 participants, but its current recruitment status is unclear.

Study design
This is a Phase 3, placebo-controlled, double-blind, randomized study, meaning participants will be randomly assigned to receive one of the treatments or a placebo without knowing which one. It plans to include 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 84 days, which suggests a follow-up period of at least 84 days for this measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219602

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome

Recruiting
PHASE3Ages 18+InterventionalPrevention
NewAmsterdam Pharma
~300 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:obicetrapib 10 mg + ezetimibe 10 mg FDC dailyObicetrapib 10 mgPlacebo

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group
Measured over 84 days

Conditions

Lipidemia
Type 2 Diabetes (T2DM)
Metabolic Syndrome (MetS)

Explore related trials

HyperlipidemiaMetabolic SyndromeType 2 Diabetes Mellitus

Where it's being run

20 sites across 13 states
Florida4
North Carolina3
Texas2
Virginia2
Arizona1
California1
Kentucky1
Maryland1

Who to contact

Gagandeep Dhillon
[email protected]
519-209-2341
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L)
Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors
Are on stable guideline-recommended lipid-lowering therapy
Estimated glomerular filtration rate ≥15 mL/min/1.73 m2

Exclusion

Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
Have been hospitalized for heart failure within 5 years prior to Screening
Have uncontrolled severe hypertension
Have a formal diagnosis of homozygous familial hypercholesterolemia
HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
active liver disease

What this trial measures

  • The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group84 days