CagriSema: What to Know While It Sits at the FDA

CagriSema has been sitting at the FDA since December 2025. For a drug that was once described as Novo Nordisk’s answer to Zepbound, it has had an unusually bumpy public run: a weaker-than-expected pivotal result, a head-to-head loss against tirzepatide, and a filing that went in anyway.

This page tracks where CagriSema actually stands, what the trials found, and what approval would and would not change for someone shopping for a weight-management medicine.

Nothing here is medical advice. Talk with a licensed healthcare provider about any weight-management treatment.

What is CagriSema?

CagriSema is a single weekly injection containing two different drugs [1]:

• Cagrilintide 2.4 mg, a long-acting analog of amylin.
• Semaglutide 2.4 mg, the same GLP-1 receptor agonist that is in Wegovy.

Amylin is a hormone released from the pancreas along with insulin whenever you eat. It slows stomach emptying and signals fullness through a different route than GLP-1 [2]. The idea behind CagriSema is that hitting two satiety pathways at once produces more weight loss than hitting one.

If approved, it would be the first FDA-approved combination of a GLP-1 receptor agonist and an amylin analog [1]. It is important to be precise about what that does and does not mean: CagriSema still contains semaglutide, so it is not a new drug class. It is semaglutide plus something.

Where is it in the FDA process?

Novo Nordisk submitted a New Drug Application for chronic weight management on December 18, 2025 [1].

As of September 14, 2026:

• The application is still under review.
• No approval has been announced.
• No FDA action date has been published. Novo Nordisk has said publicly that it expects a decision during 2026, and various trade and analyst commentaries have floated specific months, but the agency does not publish target action dates for pending applications and neither has the company.

If you see a confident “CagriSema approval date,” treat it as an estimate someone made, not a fact. The FDA’s own description of the process is that once it receives a complete application it has “6 to 10 months to make a decision on whether to approve the drug” [3]. A December 2025 filing makes a 2026 decision arithmetically plausible, and that is as far as the public record goes.

How much weight did people lose?

REDEFINE 1: the pivotal trial

REDEFINE 1 is the Phase 3 study that anchors the application. It reported 22.7% average weight loss at 68 weeks using the efficacy estimand and about 20.4% using the treatment-regimen estimand [4].

That 22.7% figure was, notably, below what analysts had expected before the readout, which is why the stock reaction at the time was negative even though the trial succeeded. It is still a very large number by historical standards: Wegovy’s original STEP 1 trial produced about 15% at 68 weeks.

REDEFINE 4: the head-to-head that did not go Novo’s way

On February 23, 2026, Novo Nordisk reported REDEFINE 4, an open-label Phase 3 trial in 809 adults that ran 84 weeks and compared CagriSema 2.4/2.4 mg directly against tirzepatide 15 mg [5][6].

CagriSema did not meet its primary endpoint of non-inferiority. Results were:

Analysis	CagriSema	Tirzepatide 15 mg
Efficacy estimand	23.0%	25.5%
Treatment-regimen estimand	20.2%	23.6%

This is worth dwelling on, because head-to-head trials are rare and this one was designed to settle an argument. CagriSema produced a lot of weight loss. It just produced less than tirzepatide in the same trial, in the same people, over the same period.

Type 2 diabetes: the REIMAGINE program

Phase 3 results from REIMAGINE 1, 2 and 3, which tested CagriSema for blood sugar control and weight in people with type 2 diabetes on a range of background therapies, were presented in a symposium at the American Diabetes Association Scientific Sessions in New Orleans on June 7, 2026 [2].

The cardiovascular outcomes trial

REDEFINE 3 (NCT05669755) is enrolling 7,101 people with cardiovascular disease and has a primary completion date of September 1, 2027 [7]. That trial, not the weight numbers, will eventually determine whether CagriSema can claim heart-protection benefits the way Wegovy does.

What are the side effects likely to be?

CagriSema contains semaglutide, so the gastrointestinal side effects familiar from Wegovy apply: nausea, vomiting, diarrhea, constipation and abdominal pain, most common during dose escalation. Adding cagrilintide has not eliminated those.

There is an interesting open question here. The whole amylin thesis across the industry is that amylin drugs are gentler on the stomach than GLP-1 drugs. Novo Nordisk is testing that directly in a Phase 1 study (NCT07607587) enrolling 114 people who could not tolerate GLP-1 therapy because of gastrointestinal side effects [8]. If cagrilintide works for that group, it changes the argument for amylin-based drugs considerably. That study has a primary completion date of November 19, 2027.

Because CagriSema is not approved, there is no FDA-reviewed label yet. The full safety picture will only be settled when one is published.

What would approval actually change for you?

Suppose the FDA approves CagriSema. Here is a realistic read on what happens next.

You would have another injectable option that is roughly in tirzepatide’s range but, on the one direct comparison available, slightly behind it. That is not nothing. Individual response varies enormously; the average result in a trial does not predict any one person’s result, and having more mechanisms available matters for people who plateau or cannot tolerate a given drug.

Pricing is unknown. Novo Nordisk has not announced a price. CagriSema contains semaglutide plus a second active ingredient, so there is no structural reason to expect it to undercut Wegovy. The company’s recent competitive moves have been on the oral side, where the Wegovy pill is advertised from $149 per month for self-pay patients — but read that number carefully: per Novo Nordisk’s own published pricing, $149 buys the 1.5 mg starting dose, while the 25 mg maintenance dose used for weight management is $299 per month [11]. Headline “starting at” prices in this category are usually titration doses, not the dose people stay on.

Insurance coverage would start from scratch. New products typically take months to appear on formularies, often with prior authorization requirements and step therapy through cheaper options first.

Supply matters. Novo Nordisk spent 2022 through 2025 dealing with semaglutide shortages. A product that contains semaglutide plus a second peptide adds manufacturing complexity. The company reported in May 2026 that it had dropped a planned single-chamber device for CagriSema, which is the kind of detail that signals manufacturing choices are still being worked out.

Can you join a CagriSema trial?

Yes, and unusually, that includes studies for children and teenagers. As of September 2026 the following were recruiting [9][10]:

• NCT07564414 — a 2,500-participant Phase 3 comparing two doses of CagriSema and one dose of semaglutide in adults with obesity, with or without type 2 diabetes. Primary completion February 23, 2028.
• NCT07253285 — a 460-participant Phase 3 of cagrilintide and CagriSema in children and adolescents with excess body weight. Primary completion March 20, 2030.
• NCT07282613 — an 80-participant Phase 3 of CagriSema in children and adolescents with type 2 diabetes.
• NCT07607587 — the Phase 1 tolerability study in people who could not stay on GLP-1 therapy.

To find them, search “CagriSema” or “cagrilintide” at clinicaltrials.gov, filter to recruiting studies, and use the Contacts and Locations tab to reach the site nearest you. Novo Nordisk also runs a study finder at novonordisk-trials.com.

How CagriSema fits in the bigger picture

CagriSema is the first of a whole wave. Almost every major developer is now building an amylin drug, usually to pair with an incretin:

• Eli Lilly has eloralintide, in five Phase 3 trials including one specifically for people already on a weekly incretin whose weight loss has stalled.
• Roche and Zealand Pharma have petrelintide, heading into Phase 3 in the second half of 2026, with a combination study alongside Roche’s dual agonist enicepatide.
• AstraZeneca started three Phase 3 trials of AZD6234 in August 2026, including one as an add-on to existing incretin therapy.
• Pfizer has PF-08653945, being tested with its monthly GLP-1 berobenatide.
• Novo Nordisk also has zenagamtide (formerly amycretin), which puts GLP-1 and amylin activity into a single molecule rather than combining two drugs.

CagriSema is the one that got to the FDA first. Whatever happens to it will shape how everyone reads the rest.

CagriSema at a glance

Item	Status as of 2026-09-14
FDA status	NDA under review since December 18, 2025; not approved
Components	Cagrilintide 2.4 mg + semaglutide 2.4 mg
Route	Once-weekly subcutaneous injection
Pivotal result	22.7% at 68 weeks (efficacy estimand), REDEFINE 1
Head-to-head	Lost to tirzepatide 15 mg in REDEFINE 4
Outcomes trial	REDEFINE 3, primary completion September 2027
Published FDA action date	None
Open trials	Yes, including two pediatric Phase 3 studies

Sources

1. Novo Nordisk, “Novo Nordisk files for FDA approval of CagriSema,” December 18, 2025 — https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html
2. Novo Nordisk, “Novo Nordisk advances cardiometabolic pipeline with new data featuring CagriSema and zenagamtide at the ADA’s 2026 Scientific Sessions,” May 27, 2026 — https://www.prnewswire.com/news-releases/novo-nordisk-advances-cardiometabolic-pipeline-with-new-data-featuring-cagrisema-and-zenagamtide-at-the-american-diabetes-associations-2026-scientific-sessions-302783110.html
3. FDA, “Step 4: FDA Drug Review” — https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review
4. Pharmaceutical Executive, “Novo Nordisk Submits NDA to FDA for CagriSema,” December 18, 2025 — https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema
5. MPR, “REDEFINE 4: CagriSema weight loss results compared with tirzepatide” — https://www.empr.com/news/redefine-4-cagrisema-weight-loss-results-compared-with-tirzepatide/
6. HCPLive, “CagriSema Demonstrates Weight Loss, Fails to Achieve Primary Endpoint Compared to Tirzepatide” — https://www.hcplive.com/view/cagrisema-demonstrates-weight-loss-fails-to-achieve-primary-endpoint-compared-to-tirzepatide
7. ClinicalTrials.gov, NCT05669755 (REDEFINE 3) — https://clinicaltrials.gov/study/NCT05669755
8. ClinicalTrials.gov, NCT07607587 — https://clinicaltrials.gov/study/NCT07607587
9. ClinicalTrials.gov, NCT07564414 — https://clinicaltrials.gov/study/NCT07564414
10. ClinicalTrials.gov, NCT07253285 — https://clinicaltrials.gov/study/NCT07253285
11. NovoCare, Wegovy pill self-pay pricing — https://www.novocare.com/patient/medicines/wegovy.html