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

NCT ID: NCT06987695

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2027-07-21

Brief 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.

Conditions

Obesity Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Maridebart Cafraglutide High Dose

Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Group Type: EXPERIMENTAL

Maridebart cafraglutide

Intervention Type: DRUG

Maridebart cafraglutide will be administered SC.

Maridebart Cafraglutide Medium Dose

Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Group Type: EXPERIMENTAL

Maridebart cafraglutide

Intervention Type: DRUG

Maridebart cafraglutide will be administered SC.

Maridebart Cafraglutide Low Dose

Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

Group Type: EXPERIMENTAL

Maridebart cafraglutide

Intervention Type: DRUG

Maridebart cafraglutide will be administered SC.

Placebo

Participants will receive placebo SC for 72 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered SC.

Interventions

Maridebart cafraglutide

Maridebart cafraglutide will be administered SC.

Intervention Type: DRUG

Placebo

Placebo will be administered SC.

Intervention Type: DRUG

Other Intervention Names

AMG 133; MariTide

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Meitetsu Hospital

Nagoya, Aichi-ken, Japan

Hosokawa Surgical Clinic

Nagoya, Aichi-ken, Japan

Social Medical Corporation Kojunkai Daido Clinic

Nagoya, Aichi-ken, Japan

Wellness Tenjin Clinic

Fukuoka, Fukuoka, Japan

Medical Corporation Boocs Boocs Clinic Fukuoka

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Tashiro Endocrinology Clinic

Fukuoka, Fukuoka, Japan

Fukuoka Shinmizumaki Hospital

Onga-gun, Fukuoka, Japan

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, Japan

Manda Memorial Hospital

Sapporo, Hokkaido, Japan

Yamasaki Family Clinic

Amagasaki-shi, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Deguchi Clinic

Kobe, Hyōgo, Japan

Nishiyamado Keiwa Hospital

Naka, Ibaraki, Japan

Aira Diabetes Thyroid Internal Medicine Clinic

Aira-shi, Kagoshima-ken, Japan

Matsuba Clinic

Kawasaki-shi, Kanagawa, Japan

Medical Corporation Keiseikai Kajiyama Clinic

Kyoto, Kyoto, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Midori Clinic

Nagasaki, Nagasaki, Japan

Urasoe General Hospital

Urasoe-shi, Okinawa, Japan

Joh Medical Clinic

Osaka, Osaka, Japan

Adachi Kyosai Hospital

Adachi-ku, Tokyo, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Kenshinkai Minamino Cardiovascular Hospital

Hachioji-shi, Tokyo, Japan

Tokyo Saiseikai Central Hospital

Minato-ku, Tokyo, Japan

Shimamura Memorial Hospital

Nerima-ku, Tokyo, Japan

MIH Clinic Yoyogi

Shibuya-ku, Tokyo, Japan

Shinjuku Southern Clinic

Shinjuku-ku, Tokyo, Japan

Ikebukuro Metropolitan Clinic

Toshima-ku, Tokyo, Japan

Countries

Japan

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20230144

Identifier Type: -

Identifier Source: org_study_id