MariTide and CV Outcomes in ASCVD Patients with Overweight or Obesity

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)

• IRAS ID

  1006252

• Contact name

  Matthew Rodaway

• Contact email

  gbinfoline@amgen.com

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2024-516652-18

• Clinicaltrials.gov Identifier

  NCT07037433

• Research summary

  Cardiovascular (CV) disease remains the leading cause of death worldwide and obesity contributes to other conditions that increase the risk of CV problems .
  This study is being done to see how maridebart cafraglutide (also known as MariTide) affects various cardiovascular health factors or conditions (related to heart and blood vessel health) in participants with Atherosclerotic Cardiovascular Disease (ASCVD) and Overweight or Obesity in addition to routine medical care.
  ASCVD is a condition in which blood vessels become narrowed or blocked due to the buildup of substances, and obesity is excessive body fat that increases the risk of various health problems.

  The Study consists of two parts. During part 1, participants will be given either MariTide or a placebo (a placebo looks the same as the investigational medicine but contains no actual medicine) over a period of approximately 35 months. Part 1 is expected to end around 15 months after the last participant is enrolled. This means that participants could be in the study for up to 3.5 years, but it could be shorter or longer, depending on when they are enrolled.

  Part 2 will continue to check if MariTide is safe and effective in reducing cardiovascular events like heart attack, stroke and heart failure, and if it helps people live longer or has any side effects. All participants in the MariTide and placebo groups who are still active in Part 1 when it ends will be given the opportunity to take part in Part 2 and will continue to receive MariTide for approximately 2 years.

  About 12800 people will take part in this study, out of which about 376 will be from the UK. This study will enrol participants until approximately March 2027.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  25/NS/0071

• Date of REC Opinion

  24 Jul 2025

• REC opinion

  Further Information Favourable Opinion