Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (MARITIME-3-J)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Obesity Disease

Treatments: Drug: Maridebart cafraglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06987695

20230144

Details and patient eligibility

About

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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

  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), 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 4 patient groups, including a placebo group

Maridebart Cafraglutide High Dose

Experimental group

Description:

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

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose

Experimental group

Description:

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

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose

Experimental group

Description:

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

Treatment:

Drug: Maridebart cafraglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC for 72 weeks.

Treatment:

Drug: Placebo