Maridebart cafraglutide: Maridebart cafraglutide will be administered SC.
Placebo: Placebo will be administered SC.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (30)
Facility
City
Region
Status
Meitetsu Hospital
Nagoya
Aichi-ken
Hosokawa Surgical Clinic
Nagoya
Aichi-ken
Social Medical Corporation Kojunkai Daido Clinic
Nagoya
Aichi-ken
Wellness Tenjin Clinic
Fukuoka
Fukuoka
Medical Corporation Boocs Boocs Clinic Fukuoka
Fukuoka
Fukuoka
Kyushu University Hospital
Fukuoka
Fukuoka
Tashiro Endocrinology Clinic
Fukuoka
Fukuoka
Fukuoka Shinmizumaki Hospital
Onga-gun
Fukuoka
Matsunami Health Promotion Clinic
Hashima-gun
Gifu
Manda Memorial Hospital
Sapporo
Hokkaido
Yamasaki Family Clinic
Amagasaki-shi
Hyōgo
Kobe University Hospital
Kobe
Hyōgo
Deguchi Clinic
Kobe
Hyōgo
Nishiyamado Keiwa Hospital
Naka
Ibaraki
Aira Diabetes Thyroid Internal Medicine Clinic
Aira-shi
Kagoshima-ken
Matsuba Clinic
Kawasaki-shi
Kanagawa
Medical Corporation Keiseikai Kajiyama Clinic
Kyoto
Kyoto
Kyoto University Hospital
Kyoto
Kyoto
Midori Clinic
Nagasaki
Nagasaki
Urasoe General Hospital
Urasoe-shi
Okinawa
Joh Medical Clinic
Osaka
Osaka
Adachi Kyosai Hospital
Adachi-ku
Tokyo
Nihonbashi Sakura Clinic
Chuo-ku
Tokyo
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku
Tokyo
Medical Corporation Kenshinkai Minamino Cardiovascular Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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