RetaMaps

Retatrutide vs CagriSema

RetaMaps Editorial· Updated October 3, 2026· Editorial review · Medical review pending
Retatrutide status
Phase 3 complete · Not FDA-approvedUpdated October 2, 2026

Retatrutide is Eli Lilly's investigational once-weekly triple agonist (GIP, GLP-1 and glucagon receptors). Five Phase 3 trials have reported positive results, and Lilly plans to submit it to the FDA in Q1 2027. It is not FDA-approved, has no brand name or price, and cannot be prescribed outside clinical trials or Lilly's physician-requested expanded access program. Products sold online as "research" or compounded retatrutide are not legitimate retatrutide.

Development
Phase 3 complete
FDA status
Submission planned — Q1 2027 (Lilly guidance)
Availability
Not commercially available
Access routes
Clinical trials, or Lilly's expanded access program (physician must apply)

Next milestone: TRIUMPH-5 head-to-head vs tirzepatide results (Expected ~Dec 2026)

Sources: Lilly — What to know about retatrutide · Lilly — TRIUMPH-2/TRIUMPH-3 results · BioPharma Dive — FDA submission plans · STAT — Lilly expanded access (Aug 3, 2026) · FDA — Concerns with unapproved GLP-1 drugs

These are the next big shots from the two companies that dominate obesity medicine — and neither is approved yet. CagriSema (Novo Nordisk) combines two drugs in one weekly injection: semaglutide, the GLP-1 drug in Ozempic and Wegovy, plus cagrilintide, which mimics amylin, a fullness hormone. Retatrutide (Eli Lilly) is a single molecule that activates three receptors: GLP-1, GIP and glucagon. [2]

Video: CagriSema vs Retatrutide (2026): Novo vs Lilly's Next Weight-Loss Shots · Watch on YouTube

The numbers, side by side

Different trials, populations, durations and methods — not a head-to-head. Both "everyone who started" figures (treatment-policy / treatment-regimen estimands) and "if everyone stayed on treatment" figures are shown so you can compare like with like. REDEFINE 1 also used flexible dosing: only 57.3% of CagriSema participants were on the top 2.4/2.4 mg dose at week 68.

[3]
CagriSema 2.4/2.4 mg — REDEFINE 1 [1]Retatrutide 12 mg — TRIUMPH-1
StatusInvestigational — FDA decision expected Q4 2026 [5]Investigational — submission planned Q1 2027
ApproachTwo drugs combined (GLP-1 + amylin)One molecule, three receptors
Duration68 weeks80 weeks
Mean weight loss (everyone who started)20.4% (vs 3.0% placebo)~25.0% [8]
If everyone stayed on treatment22.7% (vs 2.3% placebo) [2]28.3% [7]

The one head-to-head that does exist for CagriSema is against Lilly's tirzepatide, not retatrutide: in REDEFINE 4 (84 weeks), CagriSema did not meet its goal of being non-inferior to tirzepatide 15 mg — 20.2% vs 23.6% on the treatment-regimen estimand. [4] For how tirzepatide compares with retatrutide, see retatrutide vs tirzepatide.

Side effects

Both drugs show the incretin-class stomach effects, and both are dose-escalated slowly to manage them.

% of participantsCagriSema — REDEFINE 1 [2]Retatrutide 12 mg — TRIUMPH-1 [8]
Nausea55.0% (vs 12.6% placebo)42.4%
Vomiting26.1% (vs 4.1%)25.3%
Constipation30.7% (vs 11.6%)26.1%
Stopped because of side effects5.9% (vs 3.7%)11.3% (vs 4.9%)

Retatrutide also carries a dysesthesia (skin sensation) signal — see retatrutide side effects.

Where each stands with the FDA

ConfirmedNovo Nordisk submitted CagriSema to the FDA on December 18, 2025. [6] ProjectedNovo says it expects a decision in Q4 2026; Lilly plans to submit retatrutide in Q1 2027 — company guidance, not commitments. [5] Track every confirmed retatrutide milestone on the FDA approval tracker.

Until either is approved, the GLP-1 medications you can actually be prescribed are semaglutide, tirzepatide and the two new pills — see retatrutide vs weight-loss pills, the RetaMaps provider directory, and every matchup on one page: retatrutide vs other weight-loss drugs. Or get an email when retatrutide's status changes.

Sources

  1. Garvey et al., NEJM — REDEFINE 1 (CagriSema), abstract via Europe PMC (2025)
  2. Novo Nordisk Canada — REDEFINE 1 results (2025)
  3. Novo Nordisk (SEC filing) — REDEFINE 1 flexible dosing detail (Dec 2024)
  4. Clinical Trials Arena — REDEFINE 4: CagriSema vs tirzepatide (Feb 2026)
  5. Novo Nordisk — CagriSema EASD 2026 data and regulatory status (Sep 30, 2026)
  6. Novo Nordisk — CagriSema submitted to the FDA (Dec 2025)
  7. Lilly/PR Newswire — TRIUMPH-1 topline results (May 21, 2026)
  8. Pharmaceutical Journal — TRIUMPH-1 report (2026)

FAQs

Is CagriSema approved?

Not as of early October 2026. Novo Nordisk submitted it to the FDA in December 2025 and says it expects a decision in Q4 2026.

Has CagriSema been compared directly with retatrutide?

No. The closest direct data is REDEFINE 4, where CagriSema did not meet its goal of being non-inferior to tirzepatide (Zepbound) — 20.2% vs 23.6% weight loss on the treatment-regimen estimand.

What is amylin?

A hormone the pancreas releases alongside insulin that signals fullness. Cagrilintide is a long-acting amylin analogue; CagriSema pairs it with semaglutide (GLP-1).

Find weight-loss providers near you

Browse the practices RetaMaps tracks, or get an email when retatrutide's status changes.