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

NCT06987695 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20230144
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 30

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

Keywords

Overweight; BMI; Body weight; Maridebart cafraglutide; Chronic weight management; MariTide; Type 2 Diabetes Mellitus; T2DM

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Body Weight at Week 72

  Baseline and Week 72

• Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72

  Baseline and Week 72

Secondary Outcomes (30)

• Change From Baseline in Waist Circumference at Week 72

  Baseline and Week 72

• Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72

  Baseline and Week 72

• Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72

  Baseline and Week 72

• Change From Baseline in Body Weight at Week 72

  Baseline and Week 72

• Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72

  Baseline and Week 72

Study Arms (4)

Maridebart Cafraglutide High Dose

EXPERIMENTAL

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

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose

EXPERIMENTAL

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

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose

EXPERIMENTAL

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

Drug: Maridebart cafraglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC for 72 weeks.

Drug: Placebo

Interventions

Maridebart cafraglutide DRUG

Maridebart cafraglutide will be administered SC.

Also known as: AMG 133, MariTide

Maridebart Cafraglutide High Dose; Maridebart Cafraglutide Low Dose; Maridebart Cafraglutide Medium Dose

Placebo DRUG

Placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening.
• 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.
• 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:
• 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.
• Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (30)

Meitetsu Hospital

Nagoya, Aichi-ken, 451-8511, Japan

Location

Hosokawa Surgical Clinic

Nagoya, Aichi-ken, 453-0812, Japan

Location

Social Medical Corporation Kojunkai Daido Clinic

Nagoya, Aichi-ken, 457-8511, Japan

Location

Wellness Tenjin Clinic

Fukuoka, Fukuoka, 810-0001, Japan

Location

Medical Corporation Boocs Boocs Clinic Fukuoka

Fukuoka, Fukuoka, 812-0025, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Tashiro Endocrinology Clinic

Fukuoka, Fukuoka, 814-0153, Japan

Location

Fukuoka Shinmizumaki Hospital

Onga-gun, Fukuoka, 807-0051, Japan

Location

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, 501-6061, Japan

Location

Manda Memorial Hospital

Sapporo, Hokkaido, 060-0062, Japan

Location

Yamasaki Family Clinic

Amagasaki-shi, Hyōgo, 660-0861, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Deguchi Clinic

Kobe, Hyōgo, 652-0803, Japan

Location

Nishiyamado Keiwa Hospital

Naka, Ibaraki, 311-0133, Japan

Location

Aira Diabetes Thyroid Internal Medicine Clinic

Aira-shi, Kagoshima-ken, 899-5421, Japan

Location

Matsuba Clinic

Kawasaki-shi, Kanagawa, 212-0024, Japan

Location

Medical Corporation Keiseikai Kajiyama Clinic

Kyoto, Kyoto, 600-8898, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Midori Clinic

Nagasaki, Nagasaki, 852-8034, Japan

Location

Urasoe General Hospital

Urasoe-shi, Okinawa, 901-2102, Japan

Location

Joh Medical Clinic

Osaka, Osaka, 530-0002, Japan

Location

Adachi Kyosai Hospital

Adachi-ku, Tokyo, 120-0022, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Medical Corporation Kenshinkai Minamino Cardiovascular Hospital

Hachioji-shi, Tokyo, 192-0918, Japan

Location

Tokyo Saiseikai Central Hospital

Minato-ku, Tokyo, 108-0073, Japan

Location

Shimamura Memorial Hospital

Nerima-ku, Tokyo, 177-0051, Japan

Location

MIH Clinic Yoyogi

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Shinjuku Southern Clinic

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Ikebukuro Metropolitan Clinic

Toshima-ku, Tokyo, 171-0021, Japan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Body Weight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 23, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): July 21, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

JP (30)