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
Summary description of the study
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)
Intervention under investigation
Participants will receive either Maridebart Cafraglutide (3 different doses) or a placebo as a subcutaneous injection.
(BASEC)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Basel, Geneva, St. Gallen, Zurich
(BASEC)
Sponsor
Amgen Switzerland AG Amgen Inc.
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Katharina Timper
+41 61 207 07 73
katharina.timper@clutterusb.chUniversitätsspital Basel Endokrinologie, Diabetologie und Metabolismus
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
03.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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