ObesityInvestigational, not FDA-approvedEvidence tier: Human RCT (phase 2)

MariTide: Where Amgen's Investigational Drug Stands in Phase 3

Last reviewed November 1, 2026.

Quick answer

MariTide: maridebart cafraglutide, made by Amgen, studied as a once-monthly injection in trials.

FDA status: Investigational, not FDA-approved. Source: NEJM .

In a 52-week phase 2 trial in adults with obesity without diabetes, average weight change ranged from -12.3% to -16.2% across dose groups vs -2.5% on placebo, per the main (treatment-policy, intention-to-treat) analysis.

Last reviewed November 1, 2026 by the PeptideX team. Educational info, not medical advice. PeptideX doesn't give dosing advice. Talk to a licensed clinician.

FDA status: investigational, not FDA-approved. MariTide (maridebart cafraglutide, Amgen) has been studied as a once-monthly injection in trials. Phase 3 trials, called MARITIME, are under way [S1][S3].

Quick facts

  • What it is: maridebart cafraglutide, made by Amgen, studied as a once-monthly injection in trials [S1].
  • FDA status: investigational, not FDA-approved [S1].
  • Main trial result: in a 52-week phase 2 trial in adults with obesity without diabetes, average weight change ranged from -12.3% to -16.2% across dose groups vs -2.5% on placebo, per the main (treatment-policy, intention-to-treat) analysis [S1][S2].
  • Next step: phase 3 MARITIME trials are under way [S3].

What the phase 2 trial found

  • Phase 2, 52 weeks, adults with obesity without diabetes, compared with placebo [S1][S2].
  • Main analysis (treatment-policy, everyone randomized): -12.3% to -16.2% across dose groups vs -2.5% on placebo [S1][S4].
  • Amgen-reported, among people who stayed on treatment (efficacy estimand), at week 52 in phase 2: -16.3% to -19.9% across dose groups vs -2.6% on placebo. This analysis estimates results as if no one stopped treatment, so it is higher than the main analysis [S4].
  • A separate group with obesity and type 2 diabetes: -8.4% to -12.3% vs -1.7% on placebo (treatment-policy) [S1][S4].

Results come from separate trials with different people and designs, so they can't be compared directly.

What's next for MariTide

Amgen is running phase 3 MARITIME trials [S3].

Related: CagriSema (investigational), Amycretin (investigational), Orforglipron (Foundayo, FDA-approved).

Questions

Is MariTide FDA-approved?

No. It is investigational and not FDA-approved. Phase 3 trials are under way [S3].

How much weight did people lose in trials?

In a 52-week phase 2 trial in adults with obesity without diabetes, average weight change ranged from -12.3% to -16.2% across dose groups vs -2.5% on placebo (treatment-policy analysis). Amgen also reported -16.3% to -19.9% among people who stayed on treatment [S1][S4].

Can I get it?

It is not FDA-approved. Talk with a licensed clinician about your situation, including whether a clinical trial fits you. You can search open studies on ClinicalTrials.gov.

Does PeptideX tell me how to use it?

No. We do not give doses or sourcing.

Educational only. This is not medical advice. Talk with a licensed clinician before starting, stopping or changing any medicine. PeptideX doesn't give dosing advice. This page does not give doses or sourcing. peptidex.ai does not sell drugs or link to sellers. This page was drafted with AI assistance and reviewed against the sources below.

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The PeptideX team

Sources (last reviewed November 1, 2026)