Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- Summary
- The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
- Acronym
- MARITIME-2
- Short title
- Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- Official title
- A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-04-16
- First posted
- 2025-03-05
- Registry last updated
- 2025-12-31
- Primary completion date
- 2027-01-21
- Start date
- 2025-03-17
- Actual participants
- 1,105
- Participants
- 1,105
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06858878
- ClinicalTrials.gov ID
- NCT06858878
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change from Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
Change from Baseline in Waist Circumference at Week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
Timeframe: Baseline and Week 72
Percent Change from Baseline in Fasting Triglycerides at Week 72
Timeframe: Baseline and Week 72
Change from Baseline in Fasting Plasma Glucose at Week 72
Timeframe: Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Timeframe: Baseline and Week 72
Participant achieving HbA1c < 7% at week 72
Timeframe: Week 72
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
Change from Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72
Timeframe: Baseline and Week 72
Participant achieving HbA1c ≤ 6.5% at week 72
Timeframe: Week 72
Participant achieving HbA1c < 5.7%, at week 72
Timeframe: Week 72
Percent Change from Baseline in Fasting Insulin at Week 72
Timeframe: Baseline and Week 72
Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72
Timeframe: Baseline and Week 72
Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)
Timeframe: Baseline and Week 72
Change from Baseline in Diastolic Blood Pressure DBP at Week 72
Timeframe: Baseline and Week 72
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
And 3 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Healthy volunteers
- No
- Age ≥ 18 years.
- Body mass index ≥ 27 kg/m^2.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Diagnosis of T2DM.
- Type 1 diabetes mellitus.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
- Obesity induced by other endocrinologic disorders.
- Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
- History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- Lifetime history of suicide attempt.
- Alliance for Multispecialty Research MobileMobile, United States
- Gilbert Center for Family MedicineGilbert, United States
- Desert Clinical ResearchMesa, United States
- Avacare Foothills Research CenterPhoenix, United States
- San Fernando Valley Health InstituteCanoga Park, United States
- Core Healthcare GroupCerritos, United States
- Velocity Clinical Research Chula VistaChula Vista, United States
- Headlands Research CaliforniaEscondido, United States
- Paradigm Clinical ResearchModesto, United States
- Flourish ResearchNorthridge, United States
- University of California IrvineOrange, United States
- Empire Clinical ResearchPomona, United States
- Infinity Clinical TrialsSan Diego, United States
- Greenwich Clinical TrialsRiverside, United States
- Indago Research and Health CenterHialeah, United States
- Optimus U CorporationMiami, United States
- New Horizon Research CenterMiami, United States
- San Marcus Research Clinic IncMiami Lakes, United States
- Florida Institute for Clinical ResearchOrlando, United States
- Encore Medical Research of Weston LLCWeston, United States
- Conquest Research - Winter ParkWinter Park, United States
- Alliance For Multispecialty Research - Oak BrookOak Brook, United States
- Alliance for Multispecialty Research, LLC - Park RidgePark Ridge, United States
- Endeavor Health Medical Group - Endocrinology and Diabetes- SkokieSkokie, United States
- Indiana Medical Research InstituteMerrillville, United States
And 162 more, listed on the interactive page.
- Related resource (www.amgentrials.com)
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder
- Type 2 diabetes mellitus Primary condition