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Efficacy and Safety of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-1)
EU CTIS ID: 2024-515524-36-00
What this study is testing
To demonstrate that maridebart cafraglutide is superior to placebo for percentage change in body weight
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has provided informed consent before initiation of any study-specific ctivities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- BMI ≥ 30 kg/m2 at screening, OR BMI ≥ 27 to < 30 kg/m2 at screening, with at least 1 of the following weight-related comorbidities: * hypertension: treated, or with SBP ≥ 130 mmHg or DBP ≥ 80 mmHg * dyslipidemia: treated, or with: LDL ≥ 160 mg/dL (4.1 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or HDL < 40 mg/dL (1.0 mmol/L) for males or HDL < 50 mg/dL (1.3 mmol/L) for females * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Class I, II, or III heart failure) * metabolic dysfunction-associated steatotic liver disease
- History of at least 1 unsuccessful attempt at weight loss by diet and exercise
- In the opinion of the investigator, well-motivated and willing to follow study procedures for the duration of the study, including, but not limited to: following lifestyle advice, maintaining lifestyle log(s), and completing required study visits and questionnaires
You likely can't join if
- Obesity induced by other endocrinologic disorders, monogenetic or syndromic forms of obesity
- New York Heart Association Class IV heart failure
- History of unstable major depressive disorder or other severe psychiatric disorder 2 years before screening
- History of organ transplant or on transplant list
- History of other conditions that the investigator, may preclude the participant from following the protocol and completing the study
- Clinically significant gastric-emptying abnormality
See the full eligibility criteria
Who can join
- Participant has provided informed consent before initiation of any study-specific ctivities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- BMI ≥ 30 kg/m2 at screening, OR BMI ≥ 27 to < 30 kg/m2 at screening, with at least 1 of the following weight-related comorbidities: * hypertension: treated, or with SBP ≥ 130 mmHg or DBP ≥ 80 mmHg * dyslipidemia: treated, or with: LDL ≥ 160 mg/dL (4.1 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or HDL < 40 mg/dL (1.0 mmol/L) for males or HDL < 50 mg/dL (1.3 mmol/L) for females * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Class I, II, or III heart failure) * metabolic dysfunction-associated steatotic liver disease
- History of at least 1 unsuccessful attempt at weight loss by diet and exercise
- In the opinion of the investigator, well-motivated and willing to follow study procedures for the duration of the study, including, but not limited to: following lifestyle advice, maintaining lifestyle log(s), and completing required study visits and questionnaires
What rules you out
- Obesity induced by other endocrinologic disorders, monogenetic or syndromic forms of obesity
- New York Heart Association Class IV heart failure
- History of unstable major depressive disorder or other severe psychiatric disorder 2 years before screening
- History of organ transplant or on transplant list
- History of other conditions that the investigator, may preclude the participant from following the protocol and completing the study
- Clinically significant gastric-emptying abnormality
- Use 90 days before randomization of medications, supplements, or alternative remedies for weight loss
- Use 90 days before randomization of glucose-lowering drugs for the treatment of diabetes
- Use 90 days before randomization or require use during the trial of medications that may cause significant weight gain including, but not limited to chronic systemic glucocorticoid therapy, tricyclic antidepressants, atypical tetracyclic antidepressants, atypical antipsychotics, lithium, and all formulations of valproic acid
- Is receiving treatment in another investigational device or drug study, or within 90 days since ending treatment on another investigational device or drug study. This does not apply to other investigational procedures or participation in observational research studies
- Participation in a study that includes maridebart cafraglutide or AMG 598
- Self-reported change in body weight > 5kg 90 days before screening
- Hemoglobin A1c ≥ 6.5% & fasting plasma glucose ≥ 126 mg/dL at screening. If only 1 of the above labs meets the threshold at screening, then the participant should be retested for both & excluded if any repeated test result meets the threshold
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 according to 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation or receiving dialysis at screening
- Calcitonin ≥ 50 ng/L at screening
- Thyroid-stimulating hormone < 0.4 mIU/L or TSH > 6.0 mIU/L with free thyroxine below the lower limit of normal at screening
- Acute or chronic hepatitis, signs & symptoms of any liver disease other than MASLD, ALT > 3.0 x the upper limit of normal, or total bilirubin > 1.2 x ULN
- Systolic blood pressure ≥ 180 mmHg and/or DBP ≥ 120 mmHg at screening
- Patient Health Questionnaire-9 score of ≥ 15 on day 1 before randomization
- Suicidal ideation of category 4 or 5 on the Columbia-Suicide Severity Rating Scale Baseline version at screening, or on the C-SSRS Since Last Visit version on day 1 before randomization
- History of suicide attempt evaluated through C-SSRS Baseline version at screening or any suicidal behavior on the C-SSRS Since Last Visit version on day 1 before randomization
- Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment & the 16 weeks after last dose of investigational product
- Previous or planned surgical, endoscopic, or device-based treatment for obesity
- Participants who are breastfeeding or plan to breastfeed while on study through 16 weeks after last dose of investigational product
- Participants planning to become pregnant while on study and 16 weeks after the last dose of investigational product
- Participants of childbearing age with a positive pregnancy test assessed at screening and/or day 1 before randomization
- Any disorder, unwillingness, or inability, not covered by the other exclusion criteria, that in the investigator’s opinion, might jeopardize the participant’s safety or compliance with the protocol
- Major surgery planned during the study
- Investigative site personnel directly affiliated with the study and/or their immediate family
- Participant has known sensitivity to any of the products or components to be administered during dosing
- History of malignancy 5 years before screening
- Type 1 or 2 diabetes mellitus or any other types of diabetes mellitus
- History of chronic pancreatitis
- History of acute pancreatitis 180 days before screening
- Family or personal history of MTC or multiple endocrine neoplasia syndrome type 2
- History of the following 60 days before screening: myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Korea, Republic of
- Australia
- Argentina
- Switzerland
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Korea, Republic of; Australia; Argentina; Switzerland and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.