Evaluation of Maridebart Cafraglutide in Adult Participants Without 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-1
- Short title
- Evaluation of Maridebart Cafraglutide in Adult Participants Without 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 Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- 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
- 2025-10-20
- Primary completion date
- 2027-01-21
- Start date
- 2025-03-12
- Actual participants
- 3,853
- Participants
- 3,853
- 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
- NCT06858839
- ClinicalTrials.gov ID
- NCT06858839
- 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: Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Timeframe: Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Timeframe: Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Timeframe: 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 Glucose at Week 72
Timeframe: Baseline and 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
The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Change From Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Hemoglobin A1c at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Glycemic Status at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in Fasting Lipid Parameters at Week 72
Timeframe: Baseline and Week 72
Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).
Change From Baseline in Diastolic Blood Pressure (DBP) 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 Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Timeframe: Baseline and Week 72
The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 88 weeks
Plasma Concentration of Maridebart Cafraglutide at Week 72
Timeframe: Week 72
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Healthy volunteers
- No
- Age ≥ 18 years.
- Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Type 1 or Typ2 diabetes mellitus.
- Obesity induced by other endocrinologic disorders.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- 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.
- Pinnacle Research Group LLCAnniston, United States
- Alliance For Multispecialty Research - DaphneDaphne, United States
- Alliance for Multispecialty Research MobileMobile, United States
- Avacare Foothills Research CenterPhoenix, United States
- Ark Clinical Research- TustinFountain Valley, United States
- Long Beach Clinical Trials Services IncLong Beach, United States
- Ark Clinical Research- Long BeachLong Beach, United States
- Catalina Research InstituteMontclair, United States
- Artemis Institute for Clinical ResearchRiverside, United States
- Artemis Institute for Clinical ResearchSan Diego, United States
- Apex Clinical ResearchSan Diego, United States
- Southern California Clinical ResearchSanta Ana, United States
- Diablo Clinical ResearchWalnut Creek, United States
- Yale School of MedicineNew Haven, United States
- Chase Medical Research LLCWaterbury, United States
- Indago Research and Health CenterHialeah, United States
- Jacksonville Center for Clinical ResearchJacksonville, United States
- Clinical Neuroscience Solutions - JacksonvilleJacksonville, United States
- South Florida Wellness and Clinical Research InstituteMargate, United States
- Optimus U CorporationMiami, United States
- Research Institute of South FloridaMiami, United States
- Renstar Medical ResearchOcala, United States
- Clinical Neuroscience Solutions - OrlandoOrlando, United States
- Combined Research Orlando Phase I IVOrlando, United States
- Florida Institute for Clinical ResearchOrlando, United States
And 218 more, listed on the interactive page.
- Related resource (www.amgentrials.com)
Other registry identifiers
- 2024-515524-36
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition