Related Experiment Video
Updated: Jul 4, 2026
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Obicetrapib safety analysis: Pooled phase 3 clinical trial experience
Adam J Nelson1, John Jp Kastelein2, Marc Ditmarsch2
1Victorian Heart Institute, Monash University, Clayton, Australia.
American Journal of Preventive Cardiology
|July 3, 2026
Summary
Obicetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, showed a comparable safety profile to placebo in phase III trials. This study confirms the favorable tolerability of obicetrapib for cardiovascular disease patients.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Obicetrapib is a selective cholesteryl ester transfer protein (CETP) inhibitor known to lower LDL-C and raise HDL-C.
- Previous studies indicated obicetrapib's efficacy and general tolerability.
- A comprehensive safety evaluation in later-stage clinical trials was necessary.
Purpose of the Study:
- To assess the safety profile of obicetrapib compared to placebo in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD).
- To evaluate treatment-emergent adverse events (TEAEs) and specific safety endpoints over a 365-day treatment period.
Main Methods:
- Pooled analysis of two phase III clinical trials.
- Comparison of obicetrapib 10 mg daily versus placebo.
- Inclusion of 2,880 participants with HeFH or ASCVD.
- Monitoring of hepatic, muscular, glycemic, renal, and ocular parameters, along with discontinuation rates.
Main Results:
- Overall TEAE rates were similar between obicetrapib (60.2%) and placebo (62.0%).
- Adverse events leading to discontinuation were comparable (4.1% vs 5.3%).
- No significant differences were observed in blood pressure, liver, or muscle-related endpoints. Reduction in eGFR was less frequent with obicetrapib (6.7% vs 8.7%).
Conclusions:
- Obicetrapib demonstrated a favorable safety profile over 12 months, with adverse event rates comparable to placebo.
- The study extends the understanding of obicetrapib's safety and tolerability in patients with cardiovascular risk factors.
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:26Drug Administration and Therapy Phases: Overview
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
01:13Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...