CagriSema: trials, results, and current status.
Also searched as cagrilintide + semaglutide · REDEFINE 1 · REIMAGINE 1-3
CagriSema is Novo Nordisk’s investigational fixed-dose combination of cagrilintide and semaglutide. An FDA application is under review after Phase 3 weight-management results, and June 2026 REIMAGINE results add three Phase 3 type 2 diabetes trials. The sponsor projects a Q4 2026 FDA decision, but that window is not an approval or a firm agency action date.
Is CagriSema FDA approved yet?
No. Novo Nordisk submitted a CagriSema application to the FDA on December 18, 2025, but submission and review are not approval. The sponsor's projected fourth-quarter 2026 decision window is not a firm agency action date, an approved label, a launch date, or proof of current pharmacy availability.
Compare CagriSema with Retatrutide, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
Investigational clinical program
Official product and seller records attached
Investigational clinical program
What can you conclude about CagriSema today?
These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.
Cagrilintide 2.4 mg plus semaglutide 2.4 mg in the submitted regimen.
Mean loss versus 2.3% with placebo under the trial-product estimand if participants adhered to treatment.
Novo Nordisk announced its FDA submission on December 18, 2025.
An application under review is still an investigational product.
Know which molecule the result belongs to.
- Sponsor
- Novo Nordisk
- Mechanism
- Amylin analogue + GLP-1 receptor agonist
- Route being studied
- Once-weekly subcutaneous injection
- Current stage
- Phase 3 / US regulatory review
- Featured trial anchors
- NCT05567796 · NCT05669755 · NCT07011667
- Evidence checked
- July 20, 2026
CagriSema weight-loss results, with the trial attached.
This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.
Evidence checked July 21, 2026CagriSema reported 22.7% mean reduction at 68 weeks under the trial-product estimand. The comparator recorded 2.3% mean reduction.
Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.
- Population
- Adults with obesity or overweight and at least one complication
- Participants
- 3,417 Total randomized trial population across four arms
- Dose
- Cagrilintide 2.4 mg plus semaglutide 2.4 mg, flexible dosing
- Primary analysis
- Trial-product estimand
- Alternate analysis
- Treatment-policy estimand
- Regulatory status
- FDA application under review; not yet approved
CagriSema clinical trials by status, phase, and location.
The current exact-intervention snapshot matches 30 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.
Snapshot 2026-07-24Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.
What comes after Retatrutide?
Compare Zenagamtide/Amycretin, MariTide, CagriSema, standalone cagrilintide, and survodutide by route, evidence maturity, trial result, and approval status without ranking unrelated studies as one race.
Open the upcoming weight-loss drugs guide →CagriSema across 42 countries.
This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.
Compare CagriSema by country →Compare CagriSema by US state →Browse the global peptide country dataset →Is CagriSema approved or available in your country?
Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.
What the record shows - and what it doesn’t.
Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.
Pivotal Phase 3 evidence is available
In REDEFINE 1, Novo Nordisk reported 22.7% mean weight loss with CagriSema versus 2.3% with placebo at 68 weeks under the trial-product estimand. This estimand asks what happened if all participants adhered to randomized treatment; real-world discontinuation can produce a different result.
The FDA application was filed
Novo Nordisk submitted a New Drug Application on December 18, 2025 for once-weekly CagriSema 2.4 mg/2.4 mg for chronic weight management in specified adults. Filing starts a review process; it does not mean the FDA has approved the medicine.
The development program continues
ClinicalTrials.gov records show additional Phase 3 work on cardiovascular outcomes and long-term weight maintenance. The evidence base therefore extends beyond the completed pivotal weight-loss trial and will continue changing after a regulatory decision.
REIMAGINE added three type 2 diabetes results
Novo Nordisk reported June 2026 Phase 3 results from REIMAGINE 1, 2, and 3 in adults with type 2 diabetes across diet-only, oral-medicine, and basal-insulin backgrounds. The 2.4 mg/2.4 mg groups had efficacy-estimand mean weight changes of 13.8%, 14.2%, and 12.0%, respectively. Those results belong to type 2 diabetes populations and should not replace the separate 22.7% REDEFINE 1 obesity estimate.
Anticipated window, no firm FDA action date
Novo Nordisk stated in June 2026 that an FDA decision is expected in Q4 2026. That is a sponsor projection, not a published FDA action date. Review timing can change and approval is not guaranteed.
No fair heart-rate advantage claim
The cited CagriSema sources do not establish that it causes fewer heart-rate increases than retatrutide. That would require a defensible head-to-head comparison or a careful cross-program analysis.
Commercial access is not set
Until approval and launch, there is no approved label, retail price, coverage policy, legitimate pharmacy inventory, or affiliate product to compare.
The questions behind the search.
Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.
What is CagriSema?
CagriSema is an investigational fixed-dose injection combining cagrilintide, a long-acting amylin analogue, with semaglutide, a GLP-1 receptor agonist. Novo Nordisk designed the once-weekly combination to engage complementary appetite and metabolic pathways. It has completed pivotal Phase 3 weight-management trials and has been submitted to the FDA, but it remains investigational until the agency approves a specific label and formulation.
How much weight loss did CagriSema show in REDEFINE 1?
The sponsor reported 22.7% mean weight loss with CagriSema versus 2.3% with placebo at 68 weeks under the trial-product estimand, which assumes all participants remained on randomized treatment. Novo Nordisk’s submission announcement rounds that figure to 23%. The percentage should always travel with its population, duration, comparator, and estimand; it is not a promise of an individual result.
Is CagriSema FDA approved, and when is the decision?
No. Novo Nordisk announced that it submitted a New Drug Application to the FDA on December 18, 2025. As of this page’s July 20, 2026 evidence check, the sponsor still describes CagriSema as investigational and projects an FDA decision in Q4 2026. That is a sponsor window, not a firm agency action date or approval. Submission, review, approval, launch, and insurance coverage are separate milestones and should not be collapsed into “coming soon.”
What did the CagriSema REIMAGINE trials show?
REIMAGINE 1, 2, and 3 were Phase 3 trials in adults with type 2 diabetes using different background therapies and durations. Novo Nordisk reported efficacy-estimand mean weight changes of 13.8%, 14.2%, and 12.0% with CagriSema 2.4 mg/2.4 mg, respectively. Gastrointestinal adverse events were common, and discontinuation rates varied by trial. These diabetes results expand the evidence base but do not replace the separate REDEFINE obesity trials or create an approved indication.
Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.
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