GLP-1 + amylinInvestigational, not FDA-approvedEvidence tier: Human RCT (phase 3)

CagriSema: FDA Decision Expected Q4 2026 — Where It Stands Today

Last reviewed November 1, 2026. Status line re-check: weekly, and the same day a decision posts.

Quick answer

CagriSema: a combination of cagrilintide and semaglutide, made by Novo Nordisk, studied as a once-weekly injection in trials.

FDA status: Investigational, not FDA-approved. Submitted December 18, 2025; decision expected Q4 2026, per Novo (sponsor-reported). Source: Novo Nordisk .

In REDEFINE 1, a 68-week phase 3 trial in adults with obesity or overweight without diabetes, average weight change was -20.4% on CagriSema vs -3.0% on placebo, per the trial's main (treatment-policy, all-randomized) 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.

As of Nov 1, 2026: FDA decision expected Q4 2026 (sponsor-reported). CagriSema (cagrilintide plus semaglutide, Novo Nordisk) is investigational and not FDA-approved. Novo submitted it to the FDA on December 18, 2025. No FDA decision has posted as of November 1, 2026, and the FDA has not published a decision date [S2].

Quick facts

  • What it is: a combination of cagrilintide and semaglutide, made by Novo Nordisk, studied as a once-weekly injection in trials [S1][S2].
  • FDA status: investigational, not FDA-approved. Submitted December 18, 2025; decision expected Q4 2026, per Novo (sponsor-reported) [S2].
  • Main trial result: in REDEFINE 1, a 68-week phase 3 trial in adults with obesity or overweight without diabetes, average weight change was -20.4% on CagriSema vs -3.0% on placebo, per the trial's main (treatment-policy, all-randomized) analysis [S1][S3].
  • Cagrilintide alone: also investigational and not FDA-approved. REDEFINE 1 studied it as a separate arm [S1].

What the main trial found (REDEFINE 1)

  • Phase 3, 68 weeks, compared with placebo [S1][S3].
  • Average weight change: -20.4% on CagriSema vs -3.0% on placebo (treatment-policy analysis, counting everyone randomized whether or not they stayed on treatment) [S1].

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

What's next for CagriSema

The FDA is reviewing Novo's submission. Timing is the sponsor's expectation, not an FDA commitment, and can change. We will update this page the same day a decision posts [S2].

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

Questions

What were CagriSema's results?

Last checked Nov 2, 2026

CagriSema, a combination of cagrilintide and semaglutide from Novo Nordisk, is investigational and not FDA approved. In the 68-week REDEFINE 1 trial, people on CagriSema lost an average of 20.4% of body weight, compared with 3.0% on placebo, counting everyone assigned to treatment whether or not they kept taking it. Novo Nordisk submitted CagriSema to the FDA on December 18, 2025. As of November 2, 2026, the FDA hasn't made a decision; Novo Nordisk says it expects one in late 2026.

Is CagriSema FDA-approved?

No. As of November 1, 2026 it is investigational and not FDA-approved. Novo submitted it on December 18, 2025 and says it expects an FDA decision in Q4 2026 [S2].

How much weight did people lose in trials?

In the 68-week phase 3 REDEFINE 1 trial, average weight change was -20.4% on CagriSema vs -3.0% on placebo (treatment-policy analysis) [S1].

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)