CagriSema 2026: Weight Loss Results, FDA Timeline & Why You Can't Buy It Yet
CagriSema (cagrilintide + semaglutide) lost 22.7% average body weight in adults with obesity (REDEFINE 1) and 13.7% in adults with type 2 diabetes (REDEFINE 2) over 68 weeks. Novo Nordisk filed its US application on December 18, 2025; an FDA decision is expected later in 2026 with no public PDUFA date. It is not FDA-approved and not legally available as of June 2026, here is the honest data, how it stacks up against drugs you can get today, and why every site selling 'CagriSema' right now is a red flag.
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CagriSema is Novo Nordisk's investigational once-weekly injection that pairs semaglutide (the GLP-1 in Wegovy) with cagrilintide (a long-acting amylin analogue). It produced 22.7% average body-weight loss in adults with obesity (REDEFINE 1, full-adherence estimand) and 13.7% in adults with type 2 diabetes (REDEFINE 2, primary estimand) over 68 weeks. It is NOT FDA-approved as of July 2026, Novo filed the US application on December 18, 2025, and an FDA decision is expected around October 2026 (standard 10-month FDA review from the December NDA filing; Novo has not published an official PDUFA date). A February 2026 head-to-head trial (REDEFINE 4) showed CagriSema at 23.0% weight loss versus tirzepatide/Zepbound at 25.5%, with CagriSema failing the pre-specified non-inferiority margin. Meaning Zepbound is currently the higher-efficacy approved option. You cannot legally buy CagriSema yet, any telehealth site, peptide vendor, or compounding pharmacy selling 'CagriSema' today is selling an unapproved grey-market product, not the trial drug.
Quick answer, what you can actually get while you wait:
- •Highest approved weight loss today: Tirzepatide (Zepbound), ~22.5% in SURMOUNT-1, via Enhance MD from $99 first month compounded, or brand through telehealth.
- •Lowest-cost featured GLP-1: compounded semaglutide from Yucca Health $146/mo, 6-month plan.
- •Brand semaglutide (same GLP-1 inside CagriSema): Wegovy via Hers $149/mo.
- •Pill, no injection: Foundayo $149/mo starter, the first FDA-approved GLP-1 weight-loss pill.
- •Not sure which fits? Take the 2-minute match quiz or estimate cost with the cost calculator.
This page covers what CagriSema is, what the trials actually showed (population and estimand matter, most coverage gets this wrong), how it compares to drugs you can get today, and the real FDA timeline. For the broader pipeline including the triple-agonist retatrutide, see our next weight loss drugs guide.
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Compare all 53GLP-1 providers →What Is CagriSema?
CagriSema is a fixed-dose combination of cagrilintide 2.4 mg (a long-acting amylin analogue) and semaglutide 2.4 mg (the GLP-1 receptor agonist that is also the active ingredient in Wegovy), given as a single once-weekly subcutaneous injection. Novo Nordisk describes it as the first injectable combination of a GLP-1 receptor agonist and an amylin analogue for weight management. NDA filed December 18, 2025; FDA decision expected ~October 2026.
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The Trial Results, Read the Population and Estimand, Not Just the Headline
The most important thing to understand about CagriSema's numbers is that there are two different pivotal trials in two different populations, and each reports two different estimands. A percentage means nothing without all three labels. Here is the honest breakdown:
| Trial | Population | Weight loss (full-adherence) | Weight loss (treatment-policy) |
|---|---|---|---|
| REDEFINE 1 | Obesity / overweight, no diabetes (n=3,417) | 22.7% | 20.4% |
| REDEFINE 2 | Overweight / obesity WITH type 2 diabetes (n=1,206) | 15.7% | 13.7% |
"Full-adherence" (the trial-product estimand) estimates weight loss if everyone took the drug exactly as directed; "treatment-policy" reflects the real-world result including people who stopped or reduced the dose. The primary endpoint Novo and the FDA lead with is the treatment-policy figure, so the most honest single number for obesity is 20.4% (REDEFINE 1), and for type 2 diabetes 13.7% (REDEFINE 2). The 22.7% and 15.7% figures are real but represent best-case adherence.
Why does the diabetes population (REDEFINE 2) lose noticeably less than the obesity population (REDEFINE 1)? This is not a CagriSema quirk, it is a consistent pattern across every GLP-1 program. Wegovy lost ~15% in STEP-1 (obesity) but less in STEP-2 (diabetes); Zepbound lost ~22.5% in SURMOUNT-1 (obesity) but less in SURMOUNT-2 (diabetes). People with type 2 diabetes reliably lose less weight on GLP-1-class drugs, so always check which population a headline figure came from.
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How CagriSema Compares to What You Can Get Today
| Drug | Status | Avg weight loss | How to get it |
|---|---|---|---|
| CagriSema (cagrilintide + semaglutide) | Under FDA review; PDUFA ~Oct 2026 | 20.4% (obesity, treatment-policy); Zepbound beat it 25.5% vs 23.0% in REDEFINE 4 head-to-head | Not available, do not buy 'CagriSema' anywhere yet |
| Zepbound (tirzepatide) | FDA-approved | ~22.5% (SURMOUNT-1) | Brand telehealth or compounded tirzepatide |
| Wegovy (semaglutide) | FDA-approved | ~15% (STEP-1) | Hers $149/mo |
| Foundayo (orforglipron, pill) | FDA-approved Apr 2026 | ~12.4% | $149/mo starter |
The practical takeaway: CagriSema's projected real-world weight loss is in the same range as tirzepatide (Zepbound), which you can already get. If you want the highest-efficacy option available right now, compounded tirzepatide via Enhance MD is the closest match to what CagriSema is expected to deliver. Use the match quiz to see which currently-approved option fits your situation, or the cost calculator to compare out-of-pocket prices.
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Take the 60-sec QuizFDA Timeline: Filed, Not Approved
- •December 18, 2025, Novo Nordisk submitted the US NDA for CagriSema for adults with obesity, or overweight with at least one weight-related condition (source).
- •~October 2026 PDUFA (estimated), the standard FDA review clock is 10 months from NDA acceptance. Novo has not disclosed an official PDUFA date; October 2026 reflects the standard timeline. Any source claiming an earlier approval has not been confirmed by FDA or Novo Nordisk.
- •February 23, 2026: REDEFINE 4 head-to-head result: CagriSema produced 23.0% body weight loss vs tirzepatide/Zepbound at 25.5% over 72 weeks. CagriSema failed the pre-specified non-inferiority margin, meaning Zepbound is statistically the higher-efficacy option. This does not block FDA approval (non-inferiority vs a comparator is not required for NDA approval) but it changes the clinical positioning: CagriSema is not the next-tier leap Novo initially guided, it is competitive-but-second to the already-available Zepbound.
- •If approved, a commercial launch would follow the decision, with real-world telehealth availability typically ramping over the months after.
- •Trial registry, REDEFINE 2 is ClinicalTrials.gov NCT05394519 if you want the primary record.
Frequently Asked Questions
Is CagriSema FDA-approved? No. As of July 2026 it is not approved. Novo Nordisk filed the US application on December 18, 2025, and an FDA decision is expected around October 2026 based on the standard 10-month FDA review clock from the December NDA filing. Novo has not disclosed an official PDUFA date. Any source claiming an approval has occurred is misinformation.
Can I buy CagriSema now? No. It is not legally available anywhere. There is no approved or compounded version, so any product marketed as 'CagriSema' today is grey-market and not the trial drug.
How much weight does CagriSema cause you to lose? In the obesity trial (REDEFINE 1), about 20.4% of body weight on the real-world treatment-policy estimate (22.7% with full adherence) over 68 weeks. In people with type 2 diabetes (REDEFINE 2), about 13.7% (15.7% with full adherence).
Is CagriSema better than Zepbound? No: the February 2026 head-to-head trial (REDEFINE 4) showed CagriSema at 23.0% vs tirzepatide/Zepbound at 25.5%, with CagriSema failing its pre-specified non-inferiority margin. Zepbound is the higher-efficacy option you can get today. CagriSema also modestly missed Novo's own pre-trial guidance of ~25%.
How is CagriSema different from Wegovy? Wegovy is semaglutide alone (a GLP-1). CagriSema adds cagrilintide, an amylin analogue, to that same semaglutide, two appetite pathways instead of one, which is why it produces more weight loss than Wegovy's ~15%.
What This Means For You
CagriSema is under FDA review with an expected decision around October 2026. The February 2026 REDEFINE 4 head-to-head trial showed it is not ahead of Zepbound: Zepbound produced 25.5% weight loss versus CagriSema's 23.0%, with CagriSema failing non-inferiority. If you want the highest-efficacy injectable available now, tirzepatide via Enhance MD from $99 first month is the closest match to what CagriSema delivers, at a lower cost than the brand will likely carry. If you are ready to start, take the match quiz to find a currently-approved program, compare prices with the cost calculator, or read our Foundayo vs Wegovy pill and retatrutide breakdowns. We will update this page when CagriSema's FDA decision lands.
- REDEFINE 2 (type 2 diabetes), NEJM/PubMed, https://pubmed.ncbi.nlm.nih.gov/40544432/
- REDEFINE 1 (obesity, 22.7%), Novo Nordisk via PR Newswire, https://www.prnewswire.com/news-releases/cagrisema-2-4-mg--2-4-mg-demonstrated-22-7-mean-weight-reduction-in-adults-with-overweight-or-obesity-in-redefine-1--published-in-nejm-302487770.html
- REDEFINE 4 head-to-head vs tirzepatide (CagriSema 23.0% vs Zepbound 25.5%, Feb 23 2026), Clinical Trials Arena, https://www.clinicaltrialsarena.com/news/novo-nordisks-cagrisema-bested-by-lillys-zepbound-in-head-to-head-trial/
- US NDA filing (Dec 18, 2025), Novo Nordisk via BioSpace, https://www.biospace.com/press-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp-1-and-amylin-analogues-for-weight-management
- REDEFINE 2 trial registry, https://clinicaltrials.gov/study/NCT05394519
- Tirzepatide SURMOUNT-1 comparison, PubMed, https://pubmed.ncbi.nlm.nih.gov/35658024/
- Semaglutide STEP-1 comparison, PubMed, https://pubmed.ncbi.nlm.nih.gov/33567185/
Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider before starting any medication. Information is current as of the publication date but may change.
Affiliate Disclosure: Some links in this article are affiliate links. We may earn a commission if you sign up through our links, at no extra cost to you.
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What the doctors say
Verbatim, independently sourced statements from named physicians and medical bodies, real clinicians quoted with their sources, not a single paid reviewer. General clinical context, not an endorsement of any provider.
“Thanks to the latest advancements in obesity management medications, more physicians and patients are witnessing significant weight reduction beyond what they have seen before. The SURMOUNT-5 head-to-head results demonstrated tirzepatide led to greater weight reduction compared to semaglutide, providing further evidence to support tirzepatide as an effective option for obesity.”
“Patients on both medications experienced substantial weight loss, and we observed no difference in the risk of gastrointestinal adverse events. In addition to effectiveness, factors like medication availability and insurance coverage will likely play a role in deciding which medication to initiate.”
“For more than a million people at high risk of heart attack and stroke, this treatment on the NHS could be life-changing: offering a powerful new way to protect their hearts and improve their health.”
Quotes are general medical commentary about GLP-1 medications, independently sourced and not solicited by GLP-1 Picks. They are not an endorsement of any provider, our provider scores are set solely by our published methodology.