Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

Launched by AMGEN · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called maridebart cafraglutide to see if it can help adults in Japan with obesity. The main goal is to find out if this medication can lead to greater weight loss compared to a placebo, which is a treatment that doesn't contain any active medicine. Participants in the study will need to be at least 18 years old and have a body mass index (BMI) of 27 or higher, along with specific weight-related health issues like high blood pressure or type 2 diabetes.

If you qualify and decide to join, you will need to commit to following the study rules, which include keeping track of your weight and lifestyle changes. You’ll also attend regular visits and complete questionnaires about your experience. The trial is not currently recruiting participants, but if you meet the eligibility criteria, it could be a chance to help in the search for effective treatments for obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years.
• • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
• • 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.
• • For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM.
• • 1. hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening.
• • 2. 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.
• • 3. 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.
• * In the opinion of the investigator, well-motivated and willing to:
• • 1. 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.
• • 2. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).
• Exclusion Criteria:
• • Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
• • Self-reported change in body weight \> 5 kg within 90 days before screening.
• • Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
• • For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
• • For participants with T2DM at screening, any other type(s) of diabetes, mellitus except T2DM.
• • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
• • Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
• • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
• • Lifetime history of suicide attempt.