CagriSema 2026: Weight Loss Results, FDA Timeline & Why You Can't Buy It Yet

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 June 2026 — Novo filed the US application on December 18, 2025, and an FDA decision is expected later in 2026 (Novo has not disclosed a specific PDUFA date). 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 $149/mo compounded, or brand through telehealth.
• •Cheapest GLP-1 today: compounded semaglutide from Enhance MD $115/mo.
• •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.

What CagriSema Is: A GLP-1 and an Amylin Analogue in One Shot

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.

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:

"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.

How CagriSema Compares to What You Can Get Today

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.

FDA 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).
• •Later in 2026 — an FDA decision is expected. Novo has NOT published a specific PDUFA action date; reports of an exact month are speculation, not official.
• •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 June 2026 it is not approved. Novo Nordisk filed the US application on December 18, 2025, and an FDA decision is expected later in 2026. No specific approval date has been made public.

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? Based on current data, roughly comparable, not clearly better — CagriSema's ~20.4% real-world obesity result is in the same range as tirzepatide/Zepbound's ~22.5% in SURMOUNT-1. CagriSema modestly missed Novo's own ~25% guidance.

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 a genuinely strong drug that is still a year or more from your medicine cabinet, and its real-world weight loss looks competitive with — not dramatically ahead of — tirzepatide, which you can already get. If you are ready to start now, 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 the day CagriSema's FDA decision lands.