What Is CagriSema? Trial Results and FDA Status
Medically reviewed by Dr. Michael Teplitsky, MD Last reviewed 2026-10-15
Approval status and trial results for Novo Nordisk's investigational injection
CagriSema is an investigational once-weekly injection from Novo Nordisk that combines cagrilintide (2.4 mg) and semaglutide (2.4 mg) being studied for weight management and type 2 diabetes. It is not approved by the Food and Drug Administration (FDA), with an FDA decision anticipated by late 2026, according to Novo Nordisk. In the 68-week REDEFINE 1 clinical trial, participants on CagriSema achieved an average weight loss of 22.7% if all adhered to treatment.
CagriSema is an investigational once-weekly subcutaneous injection developed by Novo Nordisk that combines cagrilintide (2.4 mg) and semaglutide (2.4 mg) into a single treatment. The medication is not approved by the Food and Drug Administration (FDA). Novo Nordisk submitted an application for weight management in December 2025 and stated that an FDA decision is anticipated by late 2026.
In the phase 3 REDEFINE 1 trial, participants treated with CagriSema achieved an average weight reduction of 22.7% at 68 weeks if all adhered to treatment, compared to 2.3% for those receiving a placebo. Novo Nordisk is evaluating CagriSema in two clinical trial programs: the REDEFINE program for adults with overweight or obesity, and the REIMAGINE program for adults with type 2 diabetes (T2D). No commercial price, label or dosing guidance exists.
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CagriSema is not FDA approved. Novo Nordisk submitted CagriSema for weight management to the US Food and Drug Administration (FDA) in December 2025. This application was based on the REDEFINE 1 and REDEFINE 2 phase 3 trials.
Novo Nordisk announced that an FDA decision is anticipated by late 2026. Novo Nordisk stated that CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity.
CagriSema is an investigational product and is not approved. No commercial price, label or dosing guidance exists.
What CagriSema Contains and How It Works
CagriSema is a fixed-dose combination of two components administered together as a once-weekly subcutaneous injection. CagriSema 2.4 mg/2.4 mg combines cagrilintide 2.4 mg and semaglutide 2.4 mg. Cagrilintide is a long-acting amylin analogue, also known as an amylin receptor agonist, while semaglutide is a long-acting GLP-1 receptor agonist. Novo Nordisk describes the mechanism this way: the two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake. For more background on how semaglutide functions on its own, see our review of Wegovy benefits.
REDEFINE 1 Weight-Loss Results
In the phase 3 REDEFINE 1 trial, once-weekly CagriSema produced a 22.7% mean weight loss at 68 weeks among participants who adhered to treatment. The trial enrolled 3,417 adults with obesity or overweight with one or more comorbidities who did not have type 2 diabetes.
Trial results were published in the New England Journal of Medicine (NEJM) on 22 June 2025 and presented at the American Diabetes Association Scientific Sessions, as described in the Novo Nordisk REDEFINE 1 NEJM press release.
| Measure | CagriSema (2.4 mg / 2.4 mg) | Placebo |
|---|---|---|
| Mean weight loss (if all adhered to treatment) | 22.7% | 2.3% |
| Mean weight loss (regardless of adherence) | 20.4% | 3.0% |
| Participants with obesity reaching BMI below 30 kg/m2 | 50.7% | 10.2% |
| Discontinuation due to adverse events | 6.0% | 3.7% |
The mean baseline body mass index (BMI) for trial participants was 38 kg/m2. The protocol permitted clinical investigators to keep individual patients on a submaximal dose if deemed best for the patient.
Other Trial Results
Novo Nordisk has reported results from these Phase 3 trials. These studies include REDEFINE 2, REDEFINE 4, and REIMAGINE 2.
| Trial Name | Patient Population | Primary Findings |
|---|---|---|
| REDEFINE 2 | 1,206 adults with type 2 diabetes and obesity or overweight | CagriSema achieved a 15.7% mean weight loss at 68 weeks versus 3.1% with placebo if all adhered to treatment. Discontinuation due to adverse events was 8.4% versus 3.0%. |
| REDEFINE 4 | 809 adults with obesity and one or more comorbidities | CagriSema achieved 23.0% weight loss versus 25.5% with tirzepatide 15 mg at 84 weeks if all adhered to treatment. CagriSema did not meet the non-inferiority primary endpoint. |
| REIMAGINE 2 | 2,728 adults with type 2 diabetes uncontrolled on metformin | If all adhered, CagriSema lowered HbA1c by 1.91 percentage points versus 1.76 with semaglutide 2.4 mg, and reduced weight by 14.2% versus 10.2% with semaglutide 2.4 mg and 1.5% with placebo. |
In the REDEFINE 4 open-label trial, investigators compared once-weekly CagriSema against tirzepatide 15 mg over 84 weeks in 809 adults with a mean baseline body weight of 114.2 kg. When evaluating participants who adhered to treatment, CagriSema produced 23.0% weight loss compared to 25.5% with tirzepatide 15 mg. Under the treatment-regimen estimand, weight loss was 20.2% with CagriSema versus 23.6% with tirzepatide. CagriSema did not meet the primary endpoint of non-inferiority to tirzepatide 15 mg on weight loss at 84 weeks. Open-label means investigators and participants knew which drug was administered. To read more about how these therapies compare, see our guide on CagriSema vs Zepbound.
In the REIMAGINE 2 clinical trial, CagriSema was studied in 2,728 adults with type 2 diabetes inadequately controlled with metformin, with or without a sodium-glucose cotransporter-2 (SGLT2) inhibitor. If all adhered, CagriSema 2.4 mg/2.4 mg lowered HbA1c by 1.91 percentage points compared to 1.76 percentage points for semaglutide 2.4 mg. In that same study, weight loss reached 14.2% with CagriSema versus 10.2% with semaglutide 2.4 mg and 1.5% with placebo. Both the HbA1c and weight differences versus semaglutide were statistically superior. Novo Nordisk stated that it would approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes. For more details on this comparison, read our overview of CagriSema vs Wegovy.
Side Effects Reported in Trials
Novo Nordisk reported that the most common adverse events with CagriSema in its trials were gastrointestinal. In the REDEFINE 1 trial, 79.6% of participants who received CagriSema reported gastrointestinal adverse events, compared to 39.9% of participants who received a placebo. Novo Nordisk reported that these digestive reactions were mostly transient and mild to moderate in severity.
The most frequently reported individual symptoms in the CagriSema arm during REDEFINE 1 included:
- Nausea, reported in 55% of participants on CagriSema compared to 12.6% on placebo.
- Constipation, reported in 30.7% of participants on CagriSema compared to 11.6% on placebo.
- Vomiting, reported in 26.1% of participants on CagriSema compared to 4.1% on placebo.
Discontinuation due to adverse events was 6.0% of CagriSema participants in REDEFINE 1, compared with 3.7% on placebo. In REDEFINE 2, which studied adults with type 2 diabetes, trial discontinuation due to adverse events was 8.4% for CagriSema versus 3.0% for placebo. In the open-label REDEFINE 4 trial against tirzepatide, Novo Nordisk reported that the most common adverse events were also gastrointestinal, and were mostly mild to moderate.
What Is Still Being Studied
Novo Nordisk lists further studies. REDEFINE 3 is an event-driven cardiovascular outcomes trial of CagriSema versus placebo in 7,000 adults with established cardiovascular disease. Another evaluation is REDEFINE 11, a clinical study designed to explore the full weight-loss potential of CagriSema 2.4 mg / 2.4 mg, which was expected to report data in the first half of 2027. Additionally, Novo Nordisk stated that a higher-dose CagriSema Phase 3 trial was planned to start in the second half of 2026.
The REDEFINE trials compared CagriSema against placebo (REDEFINE 1 and 2) or tirzepatide (REDEFINE 4). This page describes no head-to-head obesity trial of CagriSema against semaglutide (Wegovy) alone. Head-to-head data against semaglutide 2.4 mg comes from REIMAGINE 2, which studied adults with type 2 diabetes rather than an obesity-only population. For a related guide, see What Is GLP-3?.
What to Do with This Information
If you are exploring medical options for weight reduction or blood sugar management, consult a licensed physician or endocrinologist to discuss currently approved therapies. Individual treatment decisions require guidance from a licensed medical professional.
Frequently Asked Questions
Is CagriSema FDA approved?
CagriSema is not FDA approved. Novo Nordisk submitted an application to the FDA for weight management in December 2025, based on the REDEFINE 1 and REDEFINE 2 trials. Novo Nordisk stated that an FDA decision is anticipated by late 2026.
Is CagriSema better than semaglutide?
No head-to-head obesity trial of CagriSema against semaglutide alone is described here. In the REIMAGINE 2 trial in adults with type 2 diabetes, if all adhered, CagriSema 2.4 mg/2.4 mg lowered HbA1c by 1.91 percentage points versus 1.76 with semaglutide 2.4 mg, and weight by 14.2% versus 10.2%; both differences were statistically superior.
Is CagriSema better than tirzepatide?
In the REDEFINE 4 clinical trial, CagriSema did not meet its primary endpoint of non-inferiority to tirzepatide 15 mg on weight loss at 84 weeks. If all adhered, CagriSema achieved a 23.0% weight reduction compared to 25.5% with tirzepatide 15 mg. Under the treatment-regimen estimand, weight loss was 20.2% with CagriSema versus 23.6% with tirzepatide.
What are the common side effects of CagriSema?
The most common side effects observed in clinical trials were gastrointestinal reactions, which were mostly transient and mild to moderate in severity. In the REDEFINE 1 trial, 79.6% of participants on CagriSema experienced gastrointestinal adverse events, compared to 39.9% on placebo. Specific events included nausea (55% versus 12.6%), constipation (30.7% versus 11.6%), and vomiting (26.1% versus 4.1%).
When will CagriSema be available in the USA?
CagriSema is not FDA approved. Novo Nordisk submitted an application for weight management in December 2025 and stated that an FDA decision is anticipated by late 2026. This page gives no approval date, and no commercial price exists.
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