Related Experiment Video

Updated: Mar 12, 2026

A Chronic High-Intensity Interval Training and Diet-Induced Obesity Model to Maximize Exercise Effort and Induce Physiologic Changes in Rats
06:28

A Chronic High-Intensity Interval Training and Diet-Induced Obesity Model to Maximize Exercise Effort and Induce Physiologic Changes in Rats

Published on: April 28, 2023

1.5K

Designing Next-Generation Cardiometabolic Outcome Trials for Obesity Medicines

Elke Platz1, Alexander Peikert2, Biykem Bozkurt3

  • 1Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA.

Journal of the American College of Cardiology
|March 11, 2026
PubMed

Insights

Obesity medications, particularly GLP-1 receptor agonists, show cardiovascular benefits. Future cardiovascular outcome trials (CVOTs) for obesity drugs need optimized designs to assess these benefits effectively.

Area of Science:

  • Cardiology
  • Endocrinology
  • Public Health

Background:

  • Obesity is a global pandemic linked to severe health issues like type 2 diabetes, hypertension, and cardiovascular disease.
  • Previous weight-loss interventions showed limited cardiovascular benefits, but recent trials with GLP-1 receptor agonists demonstrate positive CV outcomes in obese individuals.

Purpose of the Study:

  • To discuss regulatory and design considerations for cardiovascular outcome trials (CVOTs) evaluating novel obesity medications.
  • To propose principles for the next generation of cardio-kidney-metabolic outcome trials.

Main Methods:

  • Review of previous and ongoing clinical trials of obesity medications and their cardiovascular effects.
  • Analysis of regulatory aspects and study design features relevant to CVOTs for obesity.

Main Results:

  • Recent trials with glucagon-like peptide-1 (GLP-1) receptor agonists have shown significant cardiovascular benefits in individuals with obesity.
  • Multiple new CVOTs for obesity medications are planned or in progress, highlighting the need for evolving trial designs.

Conclusions:

  • The design of CVOTs for obesity medications requires careful consideration to accurately assess cardiovascular benefits.
  • Five guiding principles are proposed to inform the development of next-generation cardio-kidney-metabolic outcome trials for obesity.
Keywords:
GLP-1 receptor agonistantiobesity medicationscardiovascular outcomes trialheart failureobesitysafety

More Related Videos

Author Spotlight: Exercise Test for Evaluation of the Functional Efficacy of the Pig Cardiovascular System02:47

Author Spotlight: Exercise Test for Evaluation of the Functional Efficacy of the Pig Cardiovascular System

Published on: May 12, 2023

2.1K
Multidisciplinary Approach to Obesity Management: A Case Report05:10

Multidisciplinary Approach to Obesity Management: A Case Report

Published on: May 30, 2025

1.4K

Related Concept Videos

Pharmacokinetics in Obese Patients: Drug Absorption and Distribution01:25

Pharmacokinetics in Obese Patients: Drug Absorption and Distribution

Obesity significantly alters the pharmacokinetic processes of drug absorption and distribution, presenting unique challenges in medical treatment. The increased fat tissue and decreased lean muscle in obese individuals can significantly affect how drugs are absorbed into the body and distributed across different tissues. This alteration can lead to variances in the effectiveness and safety of medications, necessitating adjustments in dosing or drug selection for obese patients.One notable...
342
Pharmacogenomics: Identification of New Drug Targets01:29

Pharmacogenomics: Identification of New Drug Targets

Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...
59
Clinical Trials: Overview01:11

Clinical 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...
5.3K
Clinical Trials01:16

Clinical 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...
11.0K
Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion01:20

Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion

Drug metabolism, a critical process in the liver, involves two primary phases: Phase I reactions and Phase II conjugation. Obesity introduces significant alterations in this metabolic process, primarily due to fatty infiltration of the liver, leading to conditions such as nonalcoholic fatty liver disease (NAFLD). This condition can modify the activities of both Phase I and II enzymes, impacting how drugs are metabolized in obese patients.Phase I metabolism sees variable effects across...
260
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
359