Recruiting

Sponsor ID

20230144

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan who Have Obesity DiseaseMARITIME-3-J

Sponsor ID

20230144

Clinicaltrials.gov ID

NCT06987695

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

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.

Additional Study Details

Phase

Phase 3

Product

N/A

Type

Interventional

Masking

Double (Participant, Investigator)

Enrollment

272

Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change From Baseline in Body Weight at Week 72

Timeframe: Baseline and Week 72

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

Timeframe: Baseline and Week 72

Secondary Outcome Measures

Change From Baseline in Waist Circumference at Week 72

Timeframe: Baseline and Week 72

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

Timeframe: Baseline and Week 72

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

Timeframe: Baseline and Week 72

Change From Baseline in Body Weight at Week 72

Timeframe: Baseline and Week 72

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

Timeframe: Baseline and Week 72

Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72

Timeframe: Baseline and Week 72

Change From Baseline in Body Mass Index (BMI) at Week 72

Timeframe: Baseline and Week 72

Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72

Timeframe: Baseline and Week 72

Change From Baseline in Visceral Fat Area (VFA) at Week 72

Timeframe: Baseline and Week 72

Participants Achieving VFA < 100 cm^2 in VFA at Week 72

Timeframe: Week 72

Percent Change From Baseline in Fasting Total Cholesterol at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting Triglycerides at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72

Timeframe: Baseline and Week 72

Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

Timeframe: Baseline and Week 72

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72

Timeframe: Baseline and Week 72

Change From Baseline in Fasting Plasma Glucose at Week 72

Timeframe: Baseline and Week 72

Percent Change From Baseline in Fasting Insulin at Week 72

Timeframe: Baseline and Week 72

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

Timeframe: Baseline and Week 72

Percentage of Participants with a Change from Baseline in Glycemic Status at Week 72 for Participants Without T2DM at Baseline

Timeframe: Baseline and Week 72

Participants With T2DM Achieving HbA1c < 7% at Week 72

Timeframe: Week 72

Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72

Timeframe: Week 72

Participants With T2DM Achieving HbA1c < 5.7% at Week 72

Timeframe: Week 72

Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72

Timeframe: Baseline and Week 72

Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72

Timeframe: Baseline and Week 72

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Week 84

Number of Participants Experiencing Serious Adverse Events

Timeframe: Up to Week 84

Plasma Concentration of Maridebart Cafraglutide at Week 72

Timeframe: Week 72

Locations

Location

Status

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan, 103-0025

Status

Recruiting

Location

MIH Clinic Yoyogi

Shibuya-ku, Tokyo, Japan, 151-0051

Status

Recruiting

Location

Adachi Kyosai Hospital

Adachi-ku, Tokyo, Japan, 120-0022

Status

Recruiting

Location

Nishiyamado Keiwa Hospital

Naka-shi, Ibaraki, Japan, 311-0133

Status

Recruiting

Location

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, Japan, 501-6061

Status

Recruiting

Location

Joh Medical Clinic

Osaka-shi, Osaka, Japan, 530-0002

Status

Recruiting

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Study Info

Age

18 - 99 Years

Condition

Weight Loss & Obesity

Sex

All

Trial Dates

Jun 2025 - Jul 2027

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Inclusion and Exclusion 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: a. hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening. b. 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. c. 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: a. 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. b. 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.