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Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
EU CTIS ID: 2024-515523-11-00
What this study is testing
To demonstrate that maridebart cafraglutide mg is superior to placebo for percent 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 activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- BMI ≥ 27 kg/m2 at screening
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise,History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise,
- Diagnosis of T2DM at least 180 days before screening, based on the World Health Organization (WHO) classification.
- Hemogloblin A1c ≥ 7.0% (53 mmol/mol) and ≤ 10.0% (86 mmol/mol) at screening.
You likely can't join if
- Obesity induced by other endocrinologic disorders (including, but not limited to Cushing’s syndrome), or monogenetic or syndromic forms of obesity (including, but not limited to Prader Willi syndrome and melanocortin-4 receptor deficiency).
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 according to the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation or receiving dialysis at screening.
- Calcitonin ≥ 50 ng/L (pg/mL) at screening.
- History of organ transplant (except for corneal transplant) or on transplant list.
- Thyroid-stimulating hormone (TSH) < 0.4 mIU/L or TSH > 6.0 mIU/L with free thyroxine below the lower limit of normal at screening. Participants who receive treatment for hypothyroidism are permitted in the study, if their thyroid hormone replacement dose has been stable for at least 90 days before randomization and their TSH at screening is not exclusionary.
- Acute or chronic hepatitis, signs, and symptoms of any liver disease other than MASLD, alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN), or total bilirubin (TBL) > 1.2 x ULN (except for known diagnosis of Gilbert syndrome, which is not exclusionary).
See the full eligibility criteria
Who can join
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- BMI ≥ 27 kg/m2 at screening
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise,History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise,
- Diagnosis of T2DM at least 180 days before screening, based on the World Health Organization (WHO) classification.
- Hemogloblin A1c ≥ 7.0% (53 mmol/mol) and ≤ 10.0% (86 mmol/mol) at screening.
- Treatment of T2DM with diet and exercise alone and/or with a stable treatment of up to 3 oral glucose-lowering medications (as per local labeling), for at least 90 days before screening, except dipeptidyl peptidase 4 (DPP-4) inhibitors, and GLP-1RAs.
- 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 a study log(s)/diary(ies), and completing required study visits and, questionnaires. Perform self-monitoring of blood glucose (SMBG) per protocol
What rules you out
- Obesity induced by other endocrinologic disorders (including, but not limited to Cushing’s syndrome), or monogenetic or syndromic forms of obesity (including, but not limited to Prader Willi syndrome and melanocortin-4 receptor deficiency).
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 according to the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation or receiving dialysis at screening.
- Calcitonin ≥ 50 ng/L (pg/mL) at screening.
- History of organ transplant (except for corneal transplant) or on transplant list.
- Thyroid-stimulating hormone (TSH) < 0.4 mIU/L or TSH > 6.0 mIU/L with free thyroxine below the lower limit of normal at screening. Participants who receive treatment for hypothyroidism are permitted in the study, if their thyroid hormone replacement dose has been stable for at least 90 days before randomization and their TSH at screening is not exclusionary.
- Acute or chronic hepatitis, signs, and symptoms of any liver disease other than MASLD, alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN), or total bilirubin (TBL) > 1.2 x ULN (except for known diagnosis of Gilbert syndrome, which is not exclusionary).
- Systolic blood pressure > 180 mmHg and/or DBP >120 mmHg at screening.
- History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or prostate cancer in situ).
- Patient Health Questionnaire-9 (PHQ-9) score of > 15 on day 1 before randomization
- Any suicidal ideation of category 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version at screening, or on the C-SSRS Since Last Visit version on day 1 before randomization
- Lifetime 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.
- One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery. Refer to Section 11.9 (Appendix 9) for additional information.
- History of chronic pancreatitis.
- History of acute pancreatitis within 180 days before screening.
- Family (first-degree relative(s) or personal history of MTC or multiple endocrine neoplasia syndrome type 2.
- History of any other condition (including, but not limited to known drug or alcohol abuse and eating disorders) that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.
- History of any of the following within 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.
- New York Heart Association Class IV heart failure.
- History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. Participants with MDD or other psychiatric disorder whose disease state is considered stable for the past 2 years before screening and is expected to remain stable throughout the study, in the opinion of the investigator, may be eligible.
- Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 16 weeks after the last dose of investigational product. Refer to Section 11.5 (Appendix 5) for additional contraceptive information
- Participants who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of investigational product.
- Participants planning to become pregnant while on study through 16 weeks after the last dose of investigational product.
- History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 before randomization
- Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardize the participant’s safety or compliance with the protocol.
- Major surgical procedure planned during the study. Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the study may be eligible at the discretion of the investigator
- Investigative site personnel directly affiliated with the study and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Clinically significant gastric-emptying abnormality (including, but not limited to gastroparesis and gastric outlet obstruction).
- Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity. The following are allowed: liposuction and/or abdominoplasty that was performed > 1 year before screening; laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or sleeves if removed > 1 year before screening.
- Type 1 diabetes mellitus, or any other types of diabetes mellitus (except T2DM or history of gestational diabetes).
- Current or prior treatment (within 90 days before screening) with DPP-4 inhibitors, oral GLP-1RAs, or any injectable therapy for T2DM.
- History of a hematological condition (such as hemolytic anemia, sickle cell disease) that may interfere with HbA1c measurement.
- Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment. Note: A dilated fundoscopic examination or digital fundus photography with specified camera for non-dilated examination, performed by an ophthalmologist or another suitably qualified healthcare provider (eg, optometrist) within the past 90 days before screening or in the period between screening and randomization is required to verify eligibility criteria.
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor [VEGF] inhibitors). History of proliferative diabetic retinopathy, diabetic maculopathy OR severe non-proliferative diabetic retinopathy. Note: A dilated fundoscopic examination or digital fundus photography with specified camera for non-dilated examination, performed by an ophthalmologist or another suitably qualified healthcare provider (eg, optometrist) within the past 90 days before screening or in the period between screening and randomization is required to verify eligibility criteria.
- Use within 90 days before randomization or likely in the opinion of the investigator to require use during the trial of medications that may cause significant weight gain (including, but not limited to chronic (>14 days) systemic glucocorticoid therapy (topical, intraocular, intranasal, intraarticular, or inhaled preparations are allowed), atypical tricyclic antidepressants, atypical antipsychotics, llithium and all formulations of valproic acid). Note: Selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs) are permitted.
- Fasting plasma glucose > 270 mg/dL (15.0 mmol/L) at screening.
- Use within 90 days before randomization of medications, supplements, or alternative remedies for weight loss (eg, GLP-1RA, GIP agonists, phentermine/topiramate, naltrexone/bupropion, orlistat, and sympathomimetic drugs).
- Use within 90 days before randomization or likely in the opinion of the investigator to require use during the study of medications that may cause significant weight gain (including, but not limited to chronic systemic glucocorticoid therapy, tricyclic antidepressants, atypical antipsychotics, valproic acid, and lithium). Note: Selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs) are permitted.
- Currently receiving treatment in another investigational device or drug study, or less than 90 days (or 5 half-lives, whichever is longer) since ending treatment on another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies.
- Previous participation in a study that includes maridebart cafraglutide (AMG 133) or AMG 598.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- United Kingdom
- Canada
- Korea, Republic of
- Argentina
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; United Kingdom; Canada; Korea, Republic of; Argentina. Enter your location above to see the nearest site and check your eligibility.
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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.