Clinical trial

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

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT06987695

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity Disease

Full registry 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 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.

Treatments and study arms

Maridebart cafraglutide

Drug

Maridebart cafraglutide will be administered SC.

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 72Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72Baseline and Week 72

Study locations

30 locations were listed when this page was built. The first 40 are shown.

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