Clinical Trials in Japan / NCT06987695
Active, not recruiting Phase 3

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

NCT06987695 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 3
Started
2025-06-13
Last updated
2025-12-17

Condition(s) studied

Obesity Disease

Investigational drug(s) / intervention(s)

Maridebart cafraglutide →Placebo

Maridebart cafraglutide: Maridebart cafraglutide will be administered SC.

Placebo: Placebo will be administered SC.

Study summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 according to the definitions below: 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), or 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.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Meitetsu Hospital Nagoya Aichi-ken
Hosokawa Surgical Clinic Nagoya Aichi-ken
Social Medical Corporation Kojunkai Daido Clinic Nagoya Aichi-ken
Wellness Tenjin Clinic Fukuoka Fukuoka
Medical Corporation Boocs Boocs Clinic Fukuoka Fukuoka Fukuoka
Kyushu University Hospital Fukuoka Fukuoka
Tashiro Endocrinology Clinic Fukuoka Fukuoka
Fukuoka Shinmizumaki Hospital Onga-gun Fukuoka
Matsunami Health Promotion Clinic Hashima-gun Gifu
Manda Memorial Hospital Sapporo Hokkaido
Yamasaki Family Clinic Amagasaki-shi Hyōgo
Kobe University Hospital Kobe Hyōgo
Deguchi Clinic Kobe Hyōgo
Nishiyamado Keiwa Hospital Naka Ibaraki
Aira Diabetes Thyroid Internal Medicine Clinic Aira-shi Kagoshima-ken
Matsuba Clinic Kawasaki-shi Kanagawa
Medical Corporation Keiseikai Kajiyama Clinic Kyoto Kyoto
Kyoto University Hospital Kyoto Kyoto
Midori Clinic Nagasaki Nagasaki
Urasoe General Hospital Urasoe-shi Okinawa
Joh Medical Clinic Osaka Osaka
Adachi Kyosai Hospital Adachi-ku Tokyo
Nihonbashi Sakura Clinic Chuo-ku Tokyo
Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo
Medical Corporation Kenshinkai Minamino Cardiovascular Hospital Hachioji-shi Tokyo
Tokyo Saiseikai Central Hospital Minato-ku Tokyo
Shimamura Memorial Hospital Nerima-ku Tokyo
MIH Clinic Yoyogi Shibuya-ku Tokyo
Shinjuku Southern Clinic Shinjuku-ku Tokyo
Ikebukuro Metropolitan Clinic Toshima-ku Tokyo

More Amgen trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06987695 on ClinicalTrials.gov ↗ ← All trials in Japan