A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of Maridebart Cafraglutide regarding mortality and morbidity in participants with heart failure with preserved or mildly reduced ejection fraction and obesity (MARITIME-HF)

Descrizione riassuntiva dello studio

This is a Phase III study, the late development phase of drugs for humans. The researchers will compare the study drug with a placebo used for heart failure and obesity. The study is divided into 2 parts, which will be conducted sequentially: Part 1 and Part 2. Part 1 of the study is a double-blind study. This means that neither the participants nor the doctors know which study drug – whether MariTide or placebo – each participant receives until all participants have completed Part 1 of the study. This is to ensure that the study results are not influenced by the expectations of others. Participants will be randomly assigned to a treatment group. This means they will be randomly placed into a group, similar to flipping a coin or drawing numbers from a hat. Part 2 of the study is an open-label study, meaning that everyone, including participants, study doctors, and study staff, knows that all participants are receiving MariTide. Participants who have completed Part 1 will be offered to continue with Part 2. A total of approximately 4,970 patients from about 640 hospitals in the USA, Canada, Europe, South America, Asia, and Australia will be enrolled in the study. In Switzerland, about 90 patients are planned for the study across 6 hospitals.

(BASEC)

Intervento studiato

In Part 1, participants are randomly assigned to different treatment groups and receive either MariTide or placebo as an injection under the skin (subcutaneously). Participants who have completed Part 1 and received MariTide or placebo may participate in Part 2. In Part 2, all participants will receive injections of MariTide in the same way as in Part 1.

(BASEC)

Malattie studiate

Heart failure (HF) is a condition in which the heart is unable to pump enough blood to meet the body's needs. Heart failure can worsen over time. This can lead to an increased risk of early death, an increase in hospitalizations, and a decreased quality of life. Obesity is excess body fat that increases the risk of various health problems, including heart failure. A specific class of gut hormones, known as incretins (GIP and GLP-1), is important for maintaining heart health. These hormones are released after eating and help regulate insulin, blood sugar, weight, and other important processes that affect heart and metabolic health. It has already been shown that medications that mimic or enhance the effects of GLP-1 positively impact heart health and reduce the risk of cardiovascular diseases in people with and without type 2 diabetes. MariTide is a new drug currently being developed that targets metabolic pathways related to obesity. It combines two different types of treatments that can aid in weight loss (up to 15-20% of body weight) and positively influence factors such as appetite control, blood sugar management, and heart health. Due to its combined effects, MariTide may be more effective than current therapies. This study is being conducted to learn more about Maridebart-Cafraglutide (also known as MariTide) in participants with heart failure and obesity, in addition to routine medical care.

(BASEC)

Sponsor

Amgen Inc. USA Amgen Switzerland AG

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

30.07.2025

(BASEC)

Risultati dello studio