MariTide in Adults With Type 2 Diabetes Who Are Obese or Overweight

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

• IRAS ID

  1011193

• Contact name

  Matthew Rodaway

• Contact email

  UKRegClinical@amgen,com

• Sponsor organisation

  Amgen Inc

• Eudract number

  2024-515523-11

• Research summary

  In the UK obesity and overweight in adults is a serious health concern that increases the risk of many other health conditions. This phase 3 study is being done to see if maridebart cafraglutide [MariTide (formerly AMG 133)] is effective, safe, can lower body weight, and can improve weight-related conditions for people who have obesity or are overweight, and have type 2 diabetes (T2DM). MariTide is still being tested and is not approved by any regulatory agency. The study will see if MariTide is more effective than a placebo (a substance that has no medical effect but looks like MariTide) in reducing body weight and whether it causes any side effects. This study will also look at what doses of MariTide are safe for people to take and how well it is tolerated.

  Participants will be in this study for a total of 88 weeks (about 2 years) including:
  - an up to 28 day (4 weeks/1 month) screening period
  - a 72 week (about 1.5 years) treatment period
  - and a 12 week (3 months) safety follow-up period

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  25/EM/0051

• Date of REC Opinion

  23 Apr 2025

• REC opinion

  Further Information Favourable Opinion