Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease ( MARITIME-3-J )

Not yet recruiting

• Conditions: Obesity Disease

• Registration Number: jRCT2031250134
• Lead Sponsor: Amgen K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-27
• Last Update Posted: 2025-05-27

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

1. Age >= 18 years.
2. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
3. Body mass index (BMI) >= 35 kg/m^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI >= 27 kg/m^2 to < 35 kg/m^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline.
4. For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM. a. hypertension: treated, or with SBP >= 140 mmHg, or DBP >= 90 mmHg at screening. b. dyslipidemia: treated, or with LDL > 140 mg/dL (3.6 mmol/L), or triglycerides >= 150 mg/dL (1.7 mmol/L), non-HDL cholesterol > 170 mg/dL (4.4 mmol/L) or HDL < 40 mg/dL (1.0 mmol/L) at screening. c. T2DM: diagnosed >= 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists [GLP-1RA] and dipeptidyl peptidase-4 [DPP-4] inhibitors), and have a HbA1c >= 7% and <= 10% (53-86 mmol/mol) at screening.
5. In the opinion of the investigator, well-motivated and willing to: a. Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/ diary(ies), and complete required study visits and questionnaires. b. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).

Exclusion Criteria

1. Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
2. Self-reported change in body weight > 5 kg within 90 days before screening.
3. Previous or planned (during the study) surgical, endoscopic, or device based treatment for obesity.
4. For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
5. For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM.
6. History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
7. Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
8. History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
9. Lifetime history of suicide attempt.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight at Week 72	Baseline and Week 72	Percent change from baseline in body weight at Week 72
Participants Achieving >= 5% Reduction in Body Weight From Baseline at Week 72	Baseline and Week 72	Participants achieving >= 5% reduction in body weight from baseline at Week 72