A randomized, double-blind, placebo-controlled Phase III clinical trial to assess the efficacy, safety, and tolerability of Maridebart Cafraglutide in adult patients without type 2 diabetes who are obese or overweight
Descrizione riassuntiva dello studio
This is a Phase III study, the early development phase of drugs for humans. The researchers will evaluate and provide information on how well Maridebart Cafraglutide works and how well it is tolerated compared to placebo in a person for the treatment of obesity or overweight, and whether it causes side effects. The study lasts for each participant 84 weeks and includes a pre-screening period of up to 4 weeks, a 72-week treatment period, and a safety follow-up visit 12 weeks after the last dose of Maridebart Cafraglutide. The study will include men and women who are at least 18 years old and suffer from obesity or overweight, having a BMI of ≥ 30 kg/m2 or a BMI of ≥ 27 to < 30 kg/m2, and who have had at least one unsuccessful attempt to lose weight through diet and exercise in the opinion of the investigator. Participants who have type 1 or type 2 diabetes mellitus or who have had (or plan to have during the study) a surgical or endoscopic procedure for the treatment of overweight are not allowed to participate in the study. Participants who have taken or are taking unauthorized medications as part of the study are not allowed to participate.
(BASEC)
Intervento studiato
Participants will receive either Maridebart Cafraglutide (3 different doses) or a placebo as a subcutaneous injection.
(BASEC)
Malattie studiate
Obesity or overweight
(BASEC)
- Age: at least 18 years - Body Mass Index ≥ 30 kg/m2 or Body Mass Index ≥ 27 to < 30 kg/m2 with at least one of the following weight-related conditions: Hypertension Dyslipidemia Sleep apnea Cardiovascular diseases - At least one unsuccessful attempt to lose weight through diet and exercise (BASEC)
Criteri di esclusione
- Overweight induced by other endocrinological disorders - Weight change of > 5 kg within 90 days prior to the pre-screening period of the study - Type 1 or type 2 diabetes mellitus or other types of diabetes (except for gestational diabetes in the past) (BASEC)
Luogo dello studio
Basilea, Ginevra, San Gallo, Zurigo
(BASEC)
Sponsor
Amgen Switzerland AG Amgen Inc.
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Katharina Timper
+41 61 207 07 73
katharina.timper@clutterusb.chUniversitätsspital Basel Endokrinologie, Diabetologie und Metabolismus
(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
03.04.2025
(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 Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1) (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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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
Riepilogo dei risultati
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Link ai risultati nel registro primario
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