Randomized, double-blind, placebo-controlled Phase III study to assess the impact of Maridebart Cafraglutide (AMG 133) on cardiovascular endpoints in participants with atherosclerotic cardiovascular disease and overweight or obesity (MARITIME-CV)

Zusammenfassung der Studie

This is a Phase III study, the later phase in the development process of human medicines. The researchers will investigate the study drug compared to placebo in participants receiving standard treatment for ASCVD. The study is divided into 2 parts, conducted sequentially: Part 1 and Part 2. Part 1 of the study will be conducted in a double-blind manner. This means that neither the participants nor the doctors know which study drug the participants are receiving. This is done to ensure that the study results are not influenced by the expectations of the involved individuals. Participants will be randomly assigned to a treatment group, meaning they will be assigned to a group randomly, similar to flipping a coin. Part 1 of the study includes a screening phase (to confirm that participants meet the criteria for inclusion in the study) of up to 28 days and a treatment phase. If participants leave the study after Part 1, they must attend a final appointment for safety monitoring after the last dose of the study drug. Part 2 of the study will be conducted openly. This means that everyone, including the participants, study doctors, and study staff, knows that the participants are receiving MariTide. Participants who have completed Part 1 will be offered to enter Part 2. Part 2 of the study includes a treatment phase, followed by a final appointment for safety monitoring after the last dose of the study drug. In total, approximately 12,800 patients from about 690 hospitals in the USA, Canada, Europe, South America, Asia, and Australia will be enrolled in the study. In Switzerland, about 90 patients are planned to be included in 6 hospitals.

(BASEC)

Untersuchte Intervention

In Part 1, participants will be randomly assigned to different treatment groups and will 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 manner as in Part 1.

(BASEC)

Untersuchte Krankheit(en)

Cardiovascular (CV) diseases are the leading cause of death worldwide, and obesity significantly contributes to the increase in CV risk, even beyond conventional factors such as blood pressure and cholesterol. Since 1990, obesity rates have doubled. Therefore, new therapies are urgently needed to reduce CV risk in overweight individuals. 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 CV diseases in people with and without type 2 diabetes. AMG 133 is a new medication currently being developed that targets the metabolic pathways associated with 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, AMG 133 may be more effective than current therapies. This study is being conducted to investigate how AMG 133, in addition to routine medical care, affects various cardiovascular health factors or diseases (related to heart and blood vessel health) in participants with ASCVD and overweight or obesity.

(BASEC)

Sponsor

Amgen Switzerland AG, Amgen Inc.

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Datum der Bewilligung durch die Ethikkommission

18.09.2025

(BASEC)

Ergebnisse der Studie