Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity
Maridebart cafraglutide
Investigationalaka AMG 133, MariTide
Maridebart cafraglutide is an investigational once-monthly injectable being developed by Amgen for obesity and type 2 diabetes. In a Phase 2 dose-ranging trial of 592 adults, participants with obesity and without diabetes lost up to about 20 percent of body weight over 52 weeks versus about 2.6 percent with placebo, although nausea and vomiting were common. It has not been approved by any regulator and remains restricted to clinical trials, with Phase 3 studies planned.
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Mechanism
In plain terms, maridebart cafraglutide is a lab-built molecule that turns on the GLP-1 receptor to reduce appetite while blocking a second gut-hormone receptor called GIP, attached to an antibody scaffold that keeps it in the body long enough for once-monthly dosing. Technically it is a peptide-antibody conjugate in which GLP-1 receptor agonist peptides are joined to a monoclonal antibody that antagonizes the GIP receptor.
Regulatory Status by Region
- United States (FDA)Not approved. Investigational only; in clinical development for obesity and type 2 diabetes and not authorized for any indication.
- Australia (TGA)Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
- European Union (EMA)Not authorized. Investigational; no EU marketing authorisation.
- WADANot listed on the WADA Prohibited List and not in the 2026 Monitoring Program (which names only markers of semaglutide and tirzepatide).
Key Studies
- Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity, Phase 2 Trial (Jastreboff et al.) (opens in a new tab) (N Engl J Med 2025;393(9):843-857; DOI 10.1056/NEJMoa2504214; PMID 40549887; NCT05669599)
- Phase 2 dose-ranging study of AMG 133 (maridebart cafraglutide) in overweight or obesity (ClinicalTrials.gov record) (opens in a new tab) (Amgen; Phase 2 randomized placebo-controlled dose-ranging; 592 participants; NCT05669599)
Related Clinical Trials
- Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)Phase 3 · Recruiting
- Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or ObesityPhase 1 · Recruiting
- A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or OverweightPhase 2 · Recruiting
- Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure TherapyPhase 3 · Recruiting
- A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous PresentationsPhase 1 · Active Not Recruiting
- Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) TherapyPhase 3 · Recruiting
- Effect of Maridebart Cafraglutide on the Heart's Electrical ActivityPhase 1 · Active Not Recruiting
- Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) PresentationsPhase 1 · Completed
Common Questions
- What is Maridebart cafraglutide?
- Maridebart cafraglutide (MariTide, AMG 133) is an investigational once-monthly injectable from Amgen that combines GLP-1 receptor agonism with GIP receptor antagonism in a single peptide-antibody conjugate for obesity and type 2 diabetes. It is not approved by any regulator; a published Phase 2 trial reported up to about 20 percent mean weight loss, and Phase 3 trials are planned.
- Is Maridebart cafraglutide approved for medical use?
- Maridebart cafraglutide is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved. Investigational only; in clinical development for obesity and type 2 diabetes and not authorized for any indication. European Union (EMA): Not authorized. Investigational; no EU marketing authorisation. Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
- How does Maridebart cafraglutide work?
- In plain terms, maridebart cafraglutide is a lab-built molecule that turns on the GLP-1 receptor to reduce appetite while blocking a second gut-hormone receptor called GIP, attached to an antibody scaffold that keeps it in the body long enough for once-monthly dosing. Technically it is a peptide-antibody conjugate in which GLP-1 receptor agonist peptides are joined to a monoclonal antibody that antagonizes the GIP receptor.
- Is Maridebart cafraglutide legal in Australia?
- Maridebart cafraglutide in Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.
- Is Maridebart cafraglutide banned in sport?
- Maridebart cafraglutide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List and not in the 2026 Monitoring Program (which names only markers of semaglutide and tirzepatide).