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Research Report
Maridebart Cafraglutide (MariTide): A Comprehensive Clinical and Pharmacological Profile of a Novel GIPR Antagonist/GLP-1R Agonist for Obesity and Metabolic Disease
Executive Summary
Maridebart cafraglutide, brand-named MariTide and formerly known by its developmental code AMG 133, is an investigational therapeutic agent developed by Amgen poised to enter the highly competitive and rapidly expanding global market for obesity treatment.[1] It represents a significant scientific and strategic endeavor, engineered as a novel antibody-peptide conjugate, a class of molecules designed to combine the targeted action of peptides with the extended half-life of a monoclonal antibody.[2][ This report provides a comprehensive analysis of its molecular design, mechanism of action, clinical development program, competitive positioning, and future outlook.]
The therapeutic rationale for maridebart cafraglutide is rooted in a pioneering dual-action mechanism that simultaneously activates the glucagon-like peptide-1 receptor (GLP-1R) and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR).[1][ This GIPR antagonist strategy is a deliberate and contrarian scientific approach, distinguishing it from the current market leader, tirzepatide, which functions as a dual GIPR/GLP-1R]
agonist. Amgen's strategy is founded on compelling human genetic and preclinical data suggesting that inhibiting GIPR signaling may be protective against obesity and synergistic with the established weight-loss effects of GLP-1R activation.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/09/08 | Not Applicable | Recruiting | |||
2025/06/25 | Phase 3 | Recruiting | |||
2025/06/25 | Phase 3 | Recruiting | |||
2025/05/23 | Phase 3 | Recruiting | |||
2025/05/16 | Phase 1 | Completed | |||
2025/03/05 | Phase 3 | Recruiting | |||
2025/03/05 | Phase 3 | Recruiting | |||
2024/10/28 | Phase 2 | Active, not recruiting | |||
2024/04/08 | Phase 1 | Active, not recruiting | |||
2023/01/03 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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