Cagrilintide vs CagriSema: What Is the Difference?

The two names look almost the same, and a lot of articles use them as if they were one thing. They are not. One is a molecule. The other is a specific medicine built from that molecule plus a second, already approved drug. The difference matters for what the trials show and for what is actually available.

Two names, two different things

Cagrilintide is a lab-made, long-acting copy of amylin, a hormone your pancreas releases after meals. Amylin helps you feel full and slows how fast food leaves the stomach. The trial papers call cagrilintide an amylin receptor agonist, which means it switches on the same receptors amylin does. Our cagrilintide profile covers the molecule in more depth.

Semaglutide is a different kind of drug. It copies GLP-1, a gut hormone signal linked to appetite and blood sugar. It is already approved and sold as Ozempic, Rybelsus and Wegovy. See our semaglutide profile for the details.

CagriSema is Novo Nordisk's name for a fixed combination of the two. Novo Nordisk describes it as a once-weekly injectable medicine that combines cagrilintide with semaglutide at set strengths. The idea is to act on two appetite signals at once: amylin and GLP-1. So cagrilintide is an ingredient, and CagriSema is the finished, tested product.

Side by side

The key trial: REDEFINE 1, where both were tested in one study

REDEFINE 1 is the most useful trial for this question, because it put CagriSema, cagrilintide alone, semaglutide alone and placebo into the same study. That makes it a true direct comparison: same entry rules, same length, same analysis plan.

• Who took part: 3,417 adults without diabetes. Everyone had a BMI of 30 or more, or 27 or more with at least one weight-related condition such as high blood pressure. The average starting weight was 106.9 kg, per Novo Nordisk.
• Groups: 2,108 people on CagriSema, 302 on semaglutide alone, 302 on cagrilintide alone, and 705 on placebo. All groups also got lifestyle support. Neither participants nor study staff knew who got what.
• Length: 68 weeks of treatment. The registry record also lists a 2-year off-treatment extension, still running, with estimated completion in October 2026.
• Main endpoints: percent change in body weight, and the share of people losing at least 5%, for CagriSema versus placebo. CagriSema versus each single drug was a secondary endpoint.

Two ways of counting. The first column is what the journal paper leads with. It includes everyone who was randomized, even people who stopped the medicine or took something else. The second column estimates what would have happened if everyone had stayed on treatment. Novo Nordisk's headlines often use the second, which is why you will see both "20%" and "23%" quoted for the same trial. Neither number is wrong. They answer different questions.

Dose levels were not the same across groups. People could stay on a lower level if they did not tolerate increases. At week 68, Novo Nordisk reported that 57.3% of the CagriSema group were on the highest level, compared with 82.5% on cagrilintide alone and 70.2% on semaglutide alone. So part of the CagriSema group was not on the full combination by the end.

Side effects. Gut side effects, including nausea, vomiting, diarrhea, constipation and stomach pain, affected 79.6% of people on CagriSema and 39.9% on placebo. The paper describes them as mainly short-lived and mild to moderate. Novo Nordisk's summary of the paper gives nausea at 55% versus 12.6%, and vomiting at 26.1% versus 4.1%.

Stopping because of side effects. Novo Nordisk reports that 6% of the CagriSema group and 3.7% of the placebo group stopped treatment because of adverse events. We did not find stopping rates for the two single-drug groups in the sources we could access.

REDEFINE 2: people with type 2 diabetes

REDEFINE 2 tested CagriSema against placebo only. It had no single-drug groups, so it cannot tell you how cagrilintide alone compares.

• Who took part: 1,206 adults in 12 countries with type 2 diabetes, a BMI of 27 or more, and an HbA1c (a measure of average blood sugar) of 7% to 10%.
• Groups and length: 904 on CagriSema and 302 on placebo, plus lifestyle support, for 68 weeks.
• Weight: -13.7% with CagriSema versus -3.4% with placebo, counting everyone randomized (difference -10.4 percentage points, 95% CI -11.2 to -9.5).
• Blood sugar: 73.5% on CagriSema reached an HbA1c of 6.5% or less, versus 15.9% on placebo.
• Side effects: gut side effects in 72.5% versus 34.4%, mostly short-lived and mild or moderate. Novo Nordisk reports that 8.4% versus 3% stopped treatment because of adverse events.

People with type 2 diabetes usually lose less weight on these drugs than people without it. That is one reason the REDEFINE 1 and REDEFINE 2 numbers should not be lined up against each other as if they were the same test.

Other direct comparisons, and what counts as one

A fair comparison needs both treatments inside the same trial. These later studies did that. The first two are peer-reviewed; the last two are company-reported headline results.

• REIMAGINE 2 (type 2 diabetes, 68 weeks, 2,713 people, NCT06065540). Groups included CagriSema, semaglutide alone and cagrilintide alone. For the main endpoint, HbA1c fell by 1.91 points with CagriSema versus 1.75 points with semaglutide alone, a small but statistically significant difference. Novo Nordisk's announcement reports weight loss of 14.2% versus 10.2% (company figures). Adverse events were reported by 86.9% on CagriSema, 81.2% on semaglutide and 82.2% on cagrilintide. Published in The Lancet Diabetes & Endocrinology, 2026.
• REDEFINE 5 (Japan and Taiwan, 68 weeks, 331 people, NCT05813925). CagriSema versus semaglutide alone, no cagrilintide-only group. Weight change was -18.4% versus -11.9%, estimated as if everyone stayed on treatment. 10% stopped CagriSema and 6% stopped semaglutide. Published in The Lancet Diabetes & Endocrinology, 2026.
• REDEFINE 4 (obesity, 84 weeks, 809 people). An open-label trial of CagriSema versus tirzepatide, announced February 23, 2026. It did not meet its main goal of showing CagriSema was not worse. Weight loss was 20.2% versus 23.6% counting everyone, or 23.0% versus 25.5% if everyone stayed on treatment. Company-reported; the registry record matching this design is NCT06131437.
• REIMAGINE 4 (type 2 diabetes, 68 weeks). An open-label trial versus tirzepatide, reported in Novo Nordisk's August 4, 2026 interim report. CagriSema was shown not to be worse for weight loss, but not for blood sugar. Company-reported only; we found no journal paper yet.

Comparing CagriSema's numbers in one trial with a different drug's numbers in another trial is a cross-trial comparison. The people, the length, the dose rules and the way missing data are handled all differ. Those comparisons can hint at a question, but they cannot settle it. Even the semaglutide-alone group in REDEFINE 1 is not interchangeable with semaglutide's own earlier obesity trials.

Where approval actually stands

United States. Novo Nordisk announced on December 18, 2025 that it had submitted a New Drug Application to the FDA for CagriSema for long-term weight management in adults with obesity, or overweight with at least one weight-related condition. The submission was based on REDEFINE 1 and REDEFINE 2. Novo Nordisk's interim report dated August 4, 2026 lists a US decision on CagriSema as a Q4 2026 milestone. The FDA's 2026 novel drug approvals page, current as of September 14, 2026, does not list it, and openFDA's Drugs@FDA data has no cagrilintide record. So on September 15, 2026, CagriSema is under review, not approved.

European Union. Novo Nordisk's December 2025 announcement said CagriSema is not approved in the US or EU. On September 15, 2026, EMA's list of medicines had no cagrilintide product, and cagrilintide did not appear on EMA's September 2026 list of new applications under evaluation. We found no Novo Nordisk statement about an EU submission. That list only shows applications EMA has already validated, so an application could exist without appearing yet.

Cagrilintide on its own has no approval application that we could find in the US or EU. Novo Nordisk still develops it: its August 2026 report lists a Phase 3 start for a higher-dose cagrilintide program as a Q4 2026 milestone.

Company timelines are plans, not promises. A review can end in approval, a request for more data, or a delay. We will update this page when the FDA acts.

What is still uncertain

• The FDA outcome. A decision is expected in Q4 2026 per Novo Nordisk, but it has not happened, and the approved label, if any, could differ from the trial setup.
• How much cagrilintide adds. REDEFINE 1 suggests the combination beats either drug alone, but the single-drug groups had only 302 people each, and we could not access the paper's full statistics for those comparisons.
• Long-term effects. The main trials ran 68 to 84 weeks. The REDEFINE 1 extension follows people after stopping, and it has not reported.
• Tolerability. Gut side effects were very common. Fewer than 6 in 10 people on CagriSema in REDEFINE 1 were on the highest level at the end.
• Versus other drugs. In REDEFINE 4, CagriSema did not show it was not worse than tirzepatide for weight loss. In REIMAGINE 4, it met that bar for weight but not for blood sugar. Both results are company-reported so far, and we found no journal paper for either.
• The EU picture. We could not find a public EU submission. That may change without much notice.

If you are comparing the two amylin drugs rather than a molecule and its combination, see cagrilintide vs pramlintide. Pramlintide is the older amylin copy that is already approved, for diabetes.

What this does not mean