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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 (MARITIME-1)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515524-36-00
Acronym
20210181
Enrollment
1050
Registered
2025-05-26
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Weight Management

Brief summary

Percent change from baseline in body weight at week 72

Detailed description

Change from baseline in waist circumference (cm) at week 72, Achieving ≥5% reduction in body weight from baseline at week 72, Achieving ≥10% reduction in body weight from baseline at week 72, Achieving ≥15% reduction in body weight from baseline at week 72, Achieving ≥20% reduction in body weight from baseline at week 72, Change from baseline in SBP (mmHg) at week 72, Percent change from baseline in fasting triglycerides at 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, Change from baseline in fasting glucose at week 72

Interventions

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline in body weight at week 72

Secondary

MeasureTime frame
Change from baseline in waist circumference (cm) at week 72, Achieving ≥5% reduction in body weight from baseline at week 72, Achieving ≥10% reduction in body weight from baseline at week 72, Achieving ≥15% reduction in body weight from baseline at week 72, Achieving ≥20% reduction in body weight from baseline at week 72, Change from baseline in SBP (mmHg) at week 72, Percent change from baseline in fasting triglycerides at 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, Change from baseline in fasting glucose at week 72

Countries

Belgium, Czechia, Denmark, Finland, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026