DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
279
Locations
30
Results
Not posted
Publications
0
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.
Interventions
DRUG
Maridebart cafraglutide will be administered SC.
DRUG
Placebo will be administered SC.
Timeline
First posted
May 23, 2025
Study start
Jun 13, 2025
Primary completion
Apr 27, 2027
Study completion
Jul 21, 2027
Results posted
Not reported
Registry updated
Dec 17, 2025
Outcomes
Percent Change From Baseline in Body Weight at Week 72
Time frame · Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
Time frame · Baseline and Week 72
Change From Baseline in Waist Circumference at Week 72
Time frame · Baseline and Week 72
Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72
Time frame · Baseline and Week 72
Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72
Time frame · Baseline and Week 72
Change From Baseline in Body Weight at Week 72
Time frame · Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72
Time frame · Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72
Time frame · Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Time frame · Baseline and Week 72
Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72
Time frame · Baseline and Week 72
Change From Baseline in Visceral Fat Area (VFA) at Week 72
Time frame · Baseline and Week 72
Participants Achieving VFA < 100 cm^2 in VFA at Week 72
Time frame · Week 72
Eligibility
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.
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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