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CagriSema: what we know and when it might reach Spain

If you’ve heard of CagriSema, you may want to know whether it is available yet and whether its results make it worth waiting for.

Written byAlimmenta’s team of dietitian-nutritionistsReviewed byJuana María González, dietitian-nutritionist, Reg. no. CAT000921

Updated 25/09/20265 min readSee sources

CagriSema combines cagrilintide, which mimics the hormone amylin, and semaglutide, the active ingredient in Ozempic and Wegovy. In its main trial, average weight loss was 20.4% over 68 weeks [1]. It has been under review in the United States since December 2025 [2]. It is not authorised in the European Union, and there is no date for Spain.

Not yet in Spain

Status as of 26/09/2026

Under FDA review. Not yet approved in any market.

Novo Nordisk · Semaglutide + cagrilintide

Older white-haired woman reading on her laptop while sitting on a sofa

What is CagriSema, and what does it add to semaglutide?

CagriSema combines two substances in a once-weekly injection. Cagrilintide, which is still being investigated, mimics amylin, a pancreatic hormone linked to feelings of fullness. Semaglutide activates the GLP-1 hormone receptor. They act through different pathways that influence appetite and how much you eat [1].

If you know semaglutide (Ozempic, Wegovy), you’ll recognise one of the two molecules. The combination adds cagrilintide, so the semaglutide products already on sale are not the same as CagriSema. In our guide to semaglutide, we explain what each product is used for. Decisions about medicines should always be made with the healthcare professional treating you.

Where does it stand in the authorisation process?

Regulatory status changes as decisions are made by the relevant agencies. The manufacturer applied for authorisation from the US FDA in December 2025, based on the REDEFINE 1 and 2 results [2]. As of 26 September 2026, no decision is recorded. It is not authorised in the European Union. Being under review is not the same as approval, and does not tell us when it might reach Spain.

Milestone Status on 26/09/2026
Composition Cagrilintide plus semaglutide, in a once-weekly injection [1].
Research Phase 3 trials in the REDEFINE programme [1] [3].
United States Application submitted to the FDA in December 2025; under review [2].
European Union CagriSema is not authorised for marketing.
Spain No availability date.

You may see headlines giving an expected decision date in the United States. That forecast is not a decision, and does not set a date for the European Union to decide. Commercial launch and availability in Spanish pharmacies would still follow. That is why it is worth checking the status before deciding to wait.

What do the REDEFINE trials show?

In REDEFINE 1, average weight loss at 68 weeks was 20.4% with the combination, compared with 3.0% with placebo [1]. Participants were adults without diabetes who had obesity, or overweight with an associated complication. Both groups received support to change their habits. This is an average from the study; each person responds differently.

In REDEFINE 2, involving people with type 2 diabetes and obesity or overweight, average weight loss at 68 weeks was 13.7%. With placebo it was 3.4% [3]. The populations differ, so these percentages cannot be used to compare people with and without diabetes.

REDEFINE 4 compared CagriSema with tirzepatide (Mounjaro) over 84 weeks in an open-label trial, in which each person knew what they were receiving. It aimed to show that CagriSema did not achieve clearly less weight loss than tirzepatide, but it did not succeed [4]. This result does not call into question its effect compared with placebo, which was studied in REDEFINE 1 and 2.

Trial results help us understand a potential future option; your next decision depends on authorised treatments and your individual circumstances.

Our guide to GLP-1 medicines covers the options that are already authorised. Figures from different studies cannot be used to rank medicines: the participants, duration and comparison treatments vary. In a consultation, we first look at what you’re hoping to achieve, what you take and how it affects your eating.

What you can focus on while you wait

Eating well is something you can work on today, whether you already take an authorised medicine or are discussing options with your doctor. An adequate, flexible eating plan can help you look after your nutrition as your appetite changes. Recommendations for people receiving GLP-1 treatment include advice on food, activity and follow-up [5].

A small meal can include a protein food, vegetables and a source of carbohydrate. For example, lentils with vegetables and rice, or fish with potatoes and salad. The amount can be adjusted to your appetite, activity and clinical circumstances. If a prescribed treatment makes you feel nauseous, having smaller meals more often may help [5]. Discuss persistent symptoms with the person who prescribed it.

Our weekly menu for eating while taking a GLP-1 gives examples of balanced meals. It is for general guidance and needs adjusting if you have diabetes, digestive problems or other needs. You do not need to start a new medicine to organise your meals better.

Protein, strength and follow-up

Weight loss can include a loss of lean mass, which includes muscle and other tissues. Joint guidance on GLP-1 treatment recommends assessing protein intake and strength activity to help protect physical function [5]. It is not enough to look at weight: strength, energy and your ability to manage everyday tasks also matter.

Our guide to protein and muscle with GLP-1 explains how to spread protein sources across the day and get started with strength activity, based on where you are starting from. In consultations, we sometimes find that when appetite falls, the most complete meal of the day is the first to disappear. We ask about what you actually eat and look for ways to bring variety back without forcing large portions.

What we see in consultations

Waiting for a medicine can put off changes that are already within your reach. People often ask, “Should I start now or wait until it becomes available?” We can review your routine, foods you tolerate, strength activity and medical history while your doctor considers the available options. We do not prescribe medicines or change doses.

Another question is whether an average trial result guarantees the same change for you. It does not. Your starting point, how well you tolerate treatment and the consistency of follow-up all play a part. If you have a prescribed treatment, it is most helpful to coordinate your eating plan with the professional overseeing it and not change it yourself.

If you have had an eating disorder, discuss it before starting or changing a weight treatment. Your doctor and mental health team can consider the full picture with you. Your nutrition plan should also protect your relationship with food.

Your first step this week. Note which meal feels a bit lacking and which protein food would be easy for you to add.

If you would like support with eating during a treatment prescribed by your doctor, find out about our GLP-1 nutrition support. We work on your eating plan, strength and follow-up alongside your medical team.

We’ll let you know when it reaches Spain

If you’d like to receive updates, leave your email address in the form. We’ll write to you when there is confirmed information about its availability in Spain. Neither authorisation nor arrival is guaranteed.

Notice consent

Frequently asked questions about CagriSema

Can you get CagriSema in Spain yet?

No. At the date of this page, it is not authorised for sale in the European Union. If it is offered to you online, do not use it: an unauthorised product carries no guarantees about its contents or safety. Do not use it to replace a prescribed treatment either. If in doubt, speak to your doctor or pharmacist.

When will it reach Spain?

There is no confirmed date. The US FDA has been reviewing the application since December 2025 [2]. European authorisation would require a separate decision, and its arrival in Spain would then need to be confirmed.

How does it compare with tirzepatide?

In REDEFINE 4, the trial that directly compared them in people with obesity, CagriSema did not demonstrate that it achieved almost as much weight loss as tirzepatide [4]. This finding alone is not enough to choose a medicine for your situation; that is a medical decision.

When to see a doctor

When to seek medical advice

Our role. When you are taking a GLP-1 medicine, we support your eating during and after treatment. We aim to help you eat enough protein, preserve muscle, do strength training and build habits that support your weight when you stop taking it. We do not prescribe the medicine, adjust the dose or replace the person who prescribed it. If the medicine is causing problems, speak to your doctor.

Warning signs.

  • If you have severe, persistent abdominal pain, especially if it spreads to your back, seek medical attention immediately.
  • If you are taking part in a trial and vomiting or diarrhoea stops you drinking or keeping fluids down, contact the trial team today.
  • If you are taking part in a trial and have pain in the upper right side of your abdomen, yellow skin or eyes, or very pale stools, tell the medical team.
  • If you are taking part in a trial, have diabetes and take insulin or medicines that can lower your blood sugar too much, tell the medical team about any drop in blood sugar.
  • If you are taking part in a trial and notice a change in your vision, especially if you have diabetic retinopathy, tell the medical team.
  • You are losing weight very quickly, with marked weakness and loss of strength (GIRO Guide, SEEDO, 2024)

What to do. If you have pain spreading to your back with vomiting, go to A&E today or call 112: it could be pancreatitis (inflammation of the pancreas). If you have pain in the upper right side of your abdomen, yellow skin or eyes, or very pale stools, go to A&E today as well. If you cannot drink, contact your doctor today; if you also feel dizzy when standing or are barely passing urine, go to A&E. If a drop in blood sugar is severe (confusion, being unable to swallow or needing help from another person), call 112. For mild drops in blood sugar or a change in your vision, contact the person prescribing your medicine today or tomorrow. If you suddenly lose your sight, go to A&E. If you are losing weight very quickly and feel weak, contact your doctor this week: your plan can be reviewed, including strength training and protein.

In summary. Most troublesome effects of GLP-1 medicines affect digestion, are temporary and can be managed. These are the few signs that mean you should stop and seek advice.

Sources
  1. [1] Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393:635-647. doi:10.1056/NEJMoa2502081.
  2. [2] Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. Market announcement; 18 Dec 2025. novonordisk.com.
  3. [3] Davies MJ, Bajaj HS, Broholm C, et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;393:648-659. doi:10.1056/NEJMoa2502082.
  4. [4] Novo Nordisk. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved. Market announcement; 23 Feb 2026. novonordisk.com. Trial registration: NCT06131437.
  5. [5] Mozaffarian D, Agarwal M, Aggarwal M, et al. Nutritional priorities to support GLP-1 therapy for obesity: A joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and the Obesity Society. Obesity. 2025;33:1475-1503. doi:10.1002/oby.24336.

Written and reviewed by

Writing

Alimmenta’s team of dietitian-nutritionists

Registered dietitian-nutritionists

Juana María González, technical director of Alimmenta

Clinical review

Juana María González

Dietitian-nutritionist · Technical Director

Reg. no. CAT000921

Updated on September 25, 2026.5 min readView this page’s sources

Alimmenta's GLP-1 programme

Make sure what you lose is fat, and that it lasts when you stop

We support you from the first dose until a year after you stop: protein, digestive symptoms, strength, body composition and an exit plan.

  1. Assessmentbefore you start
  2. Dose escalationweeks 0-16
  3. Active weight lossmonths 4-12
  4. Plateau and maintenancefrom month 12
  5. Landingup to a year after stopping

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First visit · 45 min, in clinic or online

First visit €60

Recommended for a long treatment

10-visit pack · €480

€48 per visit. How long each phase lasts depends on you.

We don't prescribe or change your dose: your doctor does that. We work alongside them.

Cover of the PDF guide: Your first 16 weeks on a GLP-1

Your first 16 weeks on a GLP-1

  • What to eat at each dose increase
  • 7-day menu with five small meals
  • How to protect your muscle and what to do about side effects

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