Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Official 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)

Keywords

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Type 2 Diabetes Mellitus, T2DM, Obesity, Overweight, Maridebart Cafraglutide, AMG 133, MariTide, Chronic Weight Management, Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 18-99

  • Age ≥ 18 years.
  • Body mass index ≥ 27 kg/m2.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • Diagnosis of T2DM.

You CAN'T join if...

  • Type 1 diabetes mellitus.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
  • Obesity induced by other endocrinologic disorders.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Core Healthcare Group accepting new patients
    Cerritos California 90703 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06858878
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 999 study participants
Last Updated