Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
Lead Sponsor:
Amgen
Conditions:
Obesity Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2027
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT06987695
Start Date
June 13 2025
End Date
July 21 2027
Last Update
December 17 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Meitetsu Hospital
Nagoya, Aichi-ken, Japan, 451-8511
2
Hosokawa Surgical Clinic
Nagoya, Aichi-ken, Japan, 453-0812
3
Social Medical Corporation Kojunkai Daido Clinic
Nagoya, Aichi-ken, Japan, 457-8511
4
Wellness Tenjin Clinic
Fukuoka, Fukuoka, Japan, 810-0001