# CagriSema: Women's Results, FDA Date, Side Effects

Source: https://www.dietglp.com/blog/cagrisema/
Published: 2026-10-20
Keywords: cagrisema, cagrisema novo nordisk, cagrisema women, cagrisema redefine 1, cagrisema vs tirzepatide, cagrisema vs zepbound, cagrisema approval date, is cagrisema fda approved, when will cagrisema be available, cagrisema side effects, cagrisema weight loss, cagrisema price, cagrilintide plus semaglutide, cagrisema menopause

**TL;DR:** CagriSema is Novo Nordisk's once-weekly shot that combines cagrilintide (an amylin-like drug) with semaglutide, the drug in Wegovy. On October 20, 2026, Novo said women in the REDEFINE 1 trial lost about 25% of their body weight on average over 68 weeks, versus 3% on placebo. CagriSema is not FDA approved yet; Novo filed in December 2025 and expects a decision in the fourth quarter of 2026. Whatever shot you end up on, [Sharpy](https://apps.apple.com/us/app/glp-diet-app-sharpy/id6762084138) helps you protect muscle with one protein target and one 20-minute workout a day.

What is CagriSema, and why is it in the news today? **CagriSema is Novo Nordisk's once-weekly weight loss shot that pairs two drugs: cagrilintide and semaglutide.** On October 20, 2026, Novo shared a new look at its big REDEFINE 1 trial at The Menopause Society meeting in San Diego. Women on CagriSema lost about 25% of their body weight on average over 68 weeks. Women on placebo lost about 3%. CagriSema is not approved yet. The FDA decision is expected before the end of 2026.

## What is CagriSema? Cagrilintide plus semaglutide

CagriSema is a fixed-dose combination in one weekly injection:

- **Cagrilintide 2.4 mg.** A long-acting version of amylin, a hormone your pancreas releases with insulin after meals. Amylin helps you feel full and slows how fast your stomach empties.
- **Semaglutide 2.4 mg.** The GLP-1 drug in Wegovy, at the same top dose.

The idea is simple. Two fullness signals may do more together than either one alone. Novo sees CagriSema as the next step after Wegovy.

## CagriSema results in women: the October 2026 analysis

Here is what Novo reported today, as covered by Reuters and CNBC:

| Group in REDEFINE 1 | Average weight loss at 68 weeks |
|---|---|
| All women on CagriSema (2,309 women) | about 25% |
| Women on placebo | about 3% |
| Premenopausal women | 26.7% |
| Perimenopausal women | 24.8% |
| Postmenopausal women | 23.1% |
| Full trial, men and women, if everyone stayed on the drug | 22.7% (placebo 2.3%) |
| Full trial, counting everyone regardless of adherence | 20.4% (placebo 3.0%) |

Two things to keep in mind. First, this is a **post hoc analysis**, meaning it was run after the trial ended. Novo itself calls it hypothesis-generating. Second, women often lose a bit more weight than men in obesity drug trials, so the 25% number is not a new, stronger version of the drug. It is the same 2.4 mg/2.4 mg dose, looked at by sex and menopause stage.

The menopause numbers matter for many readers. Weight loss was strong in every stage, but it was a few points lower after menopause. That fits what we see with other GLP-1 drugs. Our guide to [GLP-1 during perimenopause and menopause](/blog/glp1-and-menopause/) explains why midlife weight is harder to move.

## Is CagriSema FDA approved? Approval date and timeline

| Milestone | Date |
|---|---|
| REDEFINE 1 and REDEFINE 2 published in NEJM | June 22, 2025 |
| FDA application announced | December 18, 2025 |
| REDEFINE 4 (vs tirzepatide) topline results | February 23, 2026 |
| Women and menopause analysis | October 20, 2026 |
| Expected FDA decision | Q4 2026 (no public date) |

The application asks for use with a reduced-calorie diet and more physical activity, in adults with obesity, or overweight with at least one weight-related condition. Until the FDA acts, CagriSema is only available inside clinical trials.

## CagriSema vs tirzepatide (Zepbound)

This is the question people search most, so here is the plain answer. In **REDEFINE 4**, 809 adults with obesity took either CagriSema or tirzepatide 15 mg for 84 weeks. Everyone knew which drug they were on.

| REDEFINE 4, 84 weeks | CagriSema 2.4/2.4 mg | Tirzepatide 15 mg |
|---|---|---|
| Counting everyone (treatment-regimen) | 20.2% | 23.6% |
| If everyone stayed on the drug (efficacy) | 23.0% | 25.5% |

CagriSema did not prove it was "non-inferior," meaning the trial could not show it was close enough to tirzepatide. Both drugs still produced large losses. If you are comparing future options, the honest summary is: CagriSema is in the same range as Zepbound, not clearly above it. For the next wave of drugs, see our [retatrutide guide](/blog/retatrutide-guide/).

## CagriSema in type 2 diabetes: REDEFINE 2

REDEFINE 2 studied 1,206 adults with type 2 diabetes and overweight or obesity. Over 68 weeks, people on CagriSema lost 13.7% of their weight versus 3.4% on placebo. About 74% reached an A1C of 6.5% or lower, versus 15.9% on placebo. People with diabetes usually lose less weight on these drugs than people without it.

## CagriSema side effects

The side effects look like the GLP-1 class, mostly in the gut. From Novo's REDEFINE 1 data:

| Side effect | CagriSema | Placebo |
|---|---|---|
| Any stomach side effect | 79.6% | 39.9% |
| Nausea | 55% | 12.6% |
| Constipation | 30.7% | 11.6% |
| Vomiting | 26.1% | 4.1% |
| Stopped due to side effects | 5.9% | 3.5% |

In the trials, the dose was raised step by step to lower these effects. There is no official label yet, so there is no official dosing schedule to share. Your prescriber will follow the label if it is approved. For tips that work on today's drugs, read [managing nausea on GLP-1 medications](/blog/managing-nausea-on-ozempic/).

## Losing 20% to 25% of your weight: what about muscle?

Big losses raise a fair question. How much of that weight is fat, and how much is muscle? With any GLP-1 drug, part of the weight lost can be lean mass. That is why drugs built to protect muscle, like the ones in our [trevogrumab and garetosmab guide](/blog/trevogrumab-garetosmab/), are getting attention.

You do not need to wait for a new drug to protect muscle. Two habits matter most: enough protein each day and regular strength training. Our [protein target guide](/blog/protein-target-on-glp1/) shows how to set your number. [Sharpy](https://apps.apple.com/us/app/glp-diet-app-sharpy/id6762084138) turns that into one daily protein target, one 20-minute workout and a Shape Score, so you can see whether you are losing fat and keeping muscle.

## CagriSema price, availability and where to buy

- **Price:** not announced.
- **Availability:** none outside clinical trials until FDA approval.
- **Insurance and Medicare:** coverage rules cannot be set until there is an approved label.
- **"CagriSema for sale" online:** products sold as CagriSema or "cagri-sema blends" today are not approved medicines. The FDA has not reviewed them for safety, purity or dose. Talk to your prescriber about approved options instead.

## The bottom line

CagriSema is a weekly shot that adds an amylin drug to semaglutide. Today's REDEFINE 1 analysis shows women lost about 25% of their weight on average, with slightly smaller losses after menopause. It is not approved yet, a decision is expected in Q4 2026, and in its only head-to-head trial it trailed tirzepatide. Whatever drug you take now or later, keep protein high and keep lifting. [Sharpy](https://apps.apple.com/us/app/glp-diet-app-sharpy/id6762084138) makes that a short daily habit.

## Sources

- [Novo Nordisk files for FDA approval of CagriSema, PR Newswire, 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)
- [Novo's CagriSema helped women lose 25% of weight on average, analysis shows, Reuters via Yahoo, October 20, 2026](https://www.yahoo.com/news/science/articles/novos-cagrisema-helped-women-lose-123912256.html)
- [Novo's next-generation obesity drug shows 25% weight loss in women, CNBC, October 20, 2026](https://www.cnbc.com/2026/10/20/novo-cagrisema-women-weight-loss-analysis.html)
- [REDEFINE 1 and REDEFINE 2 journal scan, American College of Cardiology, July 2025](https://www.acc.org/Latest-in-Cardiology/Journal-Scans/2025/07/02/14/43/REDEFINE-1-and-REDEFINE-2)
- [Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2), NEJM, 2025](https://www.nejm.org/doi/full/10.1056/NEJMoa2502082)
- [CagriSema fails to achieve primary endpoint compared to tirzepatide (REDEFINE 4), HCPLive, February 2026](https://www.hcplive.com/view/cagrisema-demonstrates-weight-loss-fails-to-achieve-primary-endpoint-compared-to-tirzepatide)
- [REDEFINE 1 study record, ClinicalTrials.gov NCT05567796](https://clinicaltrials.gov/study/NCT05567796)


## Frequently asked questions

**Q: What is CagriSema?**

A: CagriSema is an investigational once-weekly injection from Novo Nordisk. It combines cagrilintide 2.4 mg, a long-acting amylin analog, with semaglutide 2.4 mg, the same dose of the same drug found in Wegovy. Both act on fullness and appetite, in different ways.

**Q: Is CagriSema FDA approved?**

A: Not yet. Novo Nordisk announced its FDA application on December 18, 2025, for chronic weight management in adults with obesity, or overweight with at least one weight-related condition. Novo says it expects an FDA decision in the fourth quarter of 2026. No public decision date has been announced.

**Q: How much weight did women lose on CagriSema?**

A: In a REDEFINE 1 analysis Novo shared on October 20, 2026, 2,309 women on CagriSema lost about 25% of their body weight on average after 68 weeks, compared with about 3% on placebo. In a separate look at 1,902 women, average loss was 26.7% before menopause, 24.8% in perimenopause and 23.1% after menopause. Novo calls these post hoc results hypothesis-generating.

**Q: Is CagriSema better than Zepbound?**

A: Not in the one head-to-head trial so far. In REDEFINE 4, an 84-week open-label study of 809 adults, CagriSema led to 20.2% weight loss versus 23.6% for tirzepatide 15 mg (the drug in Zepbound) when all participants were counted. CagriSema did not meet its goal of proving it was non-inferior.

**Q: What are the side effects of CagriSema?**

A: Mostly stomach side effects, like other GLP-1 drugs. In REDEFINE 1, 79.6% of people on CagriSema had a gastrointestinal side effect versus 39.9% on placebo. Nausea hit 55%, constipation 30.7% and vomiting 26.1%. About 5.9% stopped because of side effects, versus 3.5% on placebo.

**Q: When will CagriSema be available?**

A: Only after FDA approval, which Novo expects in late 2026. Launch timing and price have not been announced. Anything sold online today as "CagriSema" or a "cagri-sema blend" is not an approved medicine.

**Q: How much will CagriSema cost?**

A: Novo Nordisk has not announced a price. For a sense of today's self-pay prices for Wegovy and Zepbound, see our weight loss pill and shot cost guides, and expect insurance coverage rules to come later.