What Is CagriSema?

1. The Short Answer

CagriSema is Novo Nordisk’s investigational once-weekly injectable combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. Novo describes semaglutide as the GLP-1 receptor agonist component and cagrilintide as a long-acting amylin analogue.

Novo Nordisk submitted a New Drug Application to the U.S. FDA on December 18, 2025, for once-weekly CagriSema injection alongside a reduced-calorie diet and increased physical activity for long-term weight reduction in adults with obesity or overweight and at least one weight-related comorbid condition.

Current status as of May 6, 2026: submitted, not approved, with Novo stating an FDA decision is anticipated by late 2026.

For class background, see What Is a GLP-1?. For the semaglutide side of the name, see What Is Semaglutide?.

2. What Are Cagrilintide and Semaglutide?

CagriSema combines two active components. Semaglutide is the GLP-1 receptor agonist already associated with products such as Wegovy, Ozempic, and Rybelsus. Cagrilintide is Novo’s long-acting amylin analogue. Novo says the two molecules reduce hunger and increase feelings of fullness through complementary pathways.

The practical naming map looks like this:

Trial program names are research context, not a substitute for a final FDA label.

3. Is CagriSema FDA-Approved?

No. CagriSema is not FDA-approved as of May 6, 2026. Novo’s December 18, 2025 FDA-submission announcement confirms CagriSema is not approved in the U.S. or EU, and a subsequent February 23, 2026 announcement noted that a U.S. FDA decision for weight management is anticipated by late 2026.

Because the application has only been submitted, there is currently no approved indication, dosing instructions, or commercial product label.

The FDA’s February 2026 statement on non-FDA-approved GLP-1 drugs indicated the agency’s intent to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded drugs marketed as alternatives, warning that the FDA cannot verify quality, safety, or efficacy for those products.

Consumers should be aware that “CagriSema” sold online, mixed from separate powders, or described as a research blend is not an FDA-reviewed product. There is no approved U.S. label to copy.

4. What Did REDEFINE 1 Report?

REDEFINE 1 was the large non-diabetes obesity trial behind much of the CagriSema discussion. Novo describes it as a 68-week, double-blind, randomized, placebo- and active-controlled phase 3 trial in 3,417 adults with obesity or overweight with one or more obesity-related complications and without type 2 diabetes.

Novo’s June 22, 2025 release says CagriSema produced 20.4% weight loss at 68 weeks versus 3.0% with placebo under the treatment-policy estimand, which counts the effect regardless of whether participants stayed on treatment or used other weight-loss therapies. Under the trial-product estimand, which asks what the effect would be if all participants adhered to treatment, Novo reported 22.7% weight loss with CagriSema versus 2.3% with placebo.

There were active comparator arms testing the combination against each component (cagrilintide 2.4 mg alone and semaglutide 2.4 mg alone) as well as placebo.

Novo also reported gastrointestinal adverse events in 79.6% of the CagriSema group versus 39.9% with placebo, including nausea, constipation, and vomiting. Discontinuation due to adverse events was 6% for CagriSema versus 3.7% for placebo.

5. What Did REDEFINE 2 Report?

REDEFINE 2 studied adults with type 2 diabetes and either obesity or overweight. Novo describes it as a 68-week, double-blind, randomized, placebo-controlled phase 3 trial with 1,206 adults evaluating CagriSema versus placebo, both with lifestyle intervention.

Novo reported an estimated mean body-weight change of 13.7% with CagriSema versus 3.4% with placebo under the treatment-policy estimand. Under the trial-product estimand, the company reported 15.7% with CagriSema versus 3.1% with placebo. Novo also reported that 83.6% of CagriSema participants lost more than 5% of body weight, compared with 30.8% of placebo participants.

While CagriSema is studied in both obesity and diabetes contexts, the December 2025 FDA submission was specifically for weight management.

For existing approved semaglutide brand context, see What Is Wegovy? and What Is Ozempic?.

6. What Happened in REDEFINE 4?

Novo’s February 23, 2026 announcement detailed an 84-week open-label phase 3 head-to-head trial of CagriSema 2.4 mg/2.4 mg versus tirzepatide 15 mg in 809 people with obesity and at least one comorbidity. The primary endpoint was non-inferiority on weight loss versus tirzepatide.

Novo reported 23.0% weight loss with CagriSema versus 25.5% with tirzepatide under the efficacy estimand, and 20.2% versus 23.6% under the treatment-regimen estimand. The company noted that the trial did not meet its primary endpoint of showing non-inferiority for CagriSema compared with tirzepatide after 84 weeks.

This does not mean CagriSema “failed to work”; rather, this specific head-to-head trial did not prove non-inferiority to tirzepatide for the primary weight-loss endpoint.

The REDEFINE 4 design was open-label, meaning participants and investigators knew which drug was being used. This is different from the double-blind design utilized in REDEFINE 1 and 2.

For tirzepatide context, see What Is Tirzepatide? and What Is Zepbound?.

7. CagriSema vs Wegovy, Zepbound, and Semaglutide

Wegovy is semaglutide. CagriSema is semaglutide plus cagrilintide. Zepbound is tirzepatide.

The breakdown:

Comparing efficacy between these medications depends heavily on trial design, dose, population, and other factors. REDEFINE 4 provides one head-to-head data point between CagriSema and tirzepatide, but it is not a finalized product-selection rule.

8. Why the Amylin Piece Matters

CagriSema differs from a semaglutide-only brand because of the inclusion of cagrilintide. Amylin is a pancreatic hormone involved in satiety and meal-related signaling. In CagriSema, Novo’s long-acting amylin analogue is paired with semaglutide’s GLP-1 receptor activity.

The main trial data showed more weight loss with the combination than with placebo or either component alone (REDEFINE 1). However, REDEFINE 4 did not show non-inferiority versus tirzepatide 15 mg on the primary weight endpoint.

While CagriSema has strong placebo-controlled data, the REDEFINE 4 head-to-head results highlight that clinical outcomes versus existing treatments like tirzepatide remain complex.

9. What About Higher-Dose CagriSema?

Novo announced in February 2026 that additional trials are exploring the full weight-loss potential of CagriSema, including higher-dose combinations. A high-dose CagriSema 2.4 mg/7.2 mg phase 3 trial is planned for the second half of 2026 in adults with obesity, while REDEFINE 11 data are expected during the first half of 2027.

These planned trials will evaluate whether different dosing ratios affect weight loss outcomes, but these higher doses currently remain purely investigational.

10. CagriSema at a Glance

11. CagriSema FAQ

• What is CagriSema in simple terms?

  CagriSema is Novo Nordisk's investigational once-weekly injectable combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. Novo describes cagrilintide as a long-acting amylin analogue and semaglutide as a GLP-1 receptor agonist.

• Is CagriSema FDA-approved?

  No. Novo Nordisk submitted a U.S. FDA New Drug Application for CagriSema on December 18, 2025, and later said an FDA decision is anticipated by late 2026. Novo also states CagriSema is not approved in the U.S. or EU.

• Is CagriSema the same as semaglutide?

  No. Semaglutide is one component of CagriSema. CagriSema combines semaglutide 2.4 mg with cagrilintide 2.4 mg, making it a GLP-1 receptor agonist and amylin analogue combination.

• What did REDEFINE 1 report?

  REDEFINE 1 studied 3,417 adults with obesity or overweight and at least one complication, without type 2 diabetes. Novo reported 20.4% weight loss with CagriSema versus 3.0% with placebo at 68 weeks under the treatment-policy estimand.

• What happened in REDEFINE 4?

  Novo reported that REDEFINE 4 compared CagriSema 2.4 mg/2.4 mg with tirzepatide 15 mg for 84 weeks in 809 people with obesity and at least one comorbidity. CagriSema did not meet the primary endpoint of non-inferiority for weight loss.

12. Sources