Clinical trial NCT06987695: Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obesity Disease
Keywords: Overweight
BMI
Body weight
Maridebart cafraglutide
Chronic weight management
MariTide
Type 2 Diabetes Mellitus
T2DM
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 weight.


Eligibility 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.

  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.

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 72
timeFrame: Baseline and Week 72
measure: Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
timeFrame: Baseline and Week 72
Secondary outcomes:
measure: Change From Baseline in Waist Circumference at Week 72
timeFrame: Baseline and Week 72
measure: Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72
timeFrame: Baseline and Week 72
measure: Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Body Weight at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Body Mass Index (BMI) at Week 72
timeFrame: Baseline and Week 72
measure: Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Visceral Fat Area (VFA) at Week 72
timeFrame: Baseline and Week 72
measure: Participants Achieving VFA < 100 cm^2 in VFA at Week 72
timeFrame: Week 72
measure: Percent Change From Baseline in Fasting Total Cholesterol at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Triglycerides at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
timeFrame: Baseline and Week 72
measure: Change From Baseline in Fasting Plasma Glucose at Week 72
timeFrame: Baseline and Week 72
measure: Percent Change From Baseline in Fasting Insulin at Week 72
timeFrame: Baseline and Week 72
measure: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
timeFrame: Baseline and Week 72
measure: 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
measure: Participants With T2DM Achieving HbA1c < 7% at Week 72
timeFrame: Week 72
measure: Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72
timeFrame: Week 72
measure: Participants With T2DM Achieving HbA1c < 5.7% at Week 72
timeFrame: Week 72
measure: 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
measure: 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
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 84
measure: Number of Participants Experiencing Serious Adverse Events
timeFrame: Up to Week 84
measure: Plasma Concentration of Maridebart Cafraglutide at Week 72
timeFrame: Week 72
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: