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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
All eligible patients must be at least 45 years old, have a BMI of at least 27 kg/m2, and have had past issues with the heart or blood vessels such as: a previous heart attack, a stroke caused by blocked blood vessels, or peripheral arterial disease (PAD) with pain while walking due to circulation problems, which may have required surgery or amputation due to artery blockages. People with and without type 2 diabetes can participate. (BASEC)
Criteri di esclusione
Patients cannot participate in the study if they have had a heart attack in the 60 days prior to the study start, have been hospitalized due to chest pain, have undergone major heart surgery, or have had a stroke or mini-stroke (TIA), plan to undergo surgery during the study to open or clear artery blockages in the heart, neck, or legs, suffer from severe heart failure (Class IV) or have been hospitalized for heart failure in the last 60 days, have type 1 diabetes or another type of diabetes other than type 2, or if diabetes occurred during pregnancy (gestational diabetes), have taken weight loss medications or medications that can lead to significant weight gain within 90 days after the study starts, plan to undergo bariatric surgery (weight reduction surgery) at the time of enrollment in the study or within 180 days prior to enrollment in this study, or plan a pregnancy during the study participation and up to 16 weeks after the last dose of the investigational product. (BASEC)
Luogo dello studio
Basilea, Berna, Ginevra, Losanna, Lugano, Zurigo
(BASEC)
Sponsor
Amgen Switzerland AG, Amgen Inc.
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Otmar Pfister
+41 61 265 25 25
otmar.pfister@clutterusb.chUniversitätsspital Basel, Universitäres Herzzentrum Basel
(BASEC)
Informazioni scientifiche
non disponibile
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
18.09.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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) (BASEC)
Titolo accademico
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Titolo pubblico
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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Link ai risultati nel registro primario
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