CagriSema Dosage: REDEFINE Trial Doses, Blend Vials and Filing Status
CagriSema dosage: the REDEFINE 1 trial dose of cagrilintide 2.4 mg plus semaglutide 2.4 mg weekly, research-sold blend vials, and Novo Nordisk's FDA filing status.
The short version
CagriSema is Novo Nordisk's fixed-dose combination of cagrilintide and semaglutide, dosed at 2.4 mg of each per week in its Phase 3 REDEFINE 1 trial. It is not FDA-approved. Novo Nordisk filed for approval in December 2025 and expects a decision in 2026. Vials sold to consumers as research CagriSema are a different, unreviewed product from the trial drug, though vendor sources describe the same 2.4 mg/2.4 mg weekly target.
- REDEFINE 1 dosed CagriSema at 2.4 mg cagrilintide plus 2.4 mg semaglutide, once weekly, reached by escalation.
- CagriSema is not FDA-approved. Novo Nordisk filed a New Drug Application on 18 December 2025 and expects a decision in 2026.
- Research-sold blend vials commonly come as 20 mg total: 10 mg cagrilintide plus 10 mg semaglutide, a 1:1 ratio.
- Semaglutide alone is FDA-approved as Ozempic, Wegovy and Rybelsus; cagrilintide alone has no approved product at all.
CagriSema is Novo Nordisk’s name for the fixed-dose combination of cagrilintide and semaglutide, studied together in the company’s REDEFINE Phase 3 trial program. It has no FDA-approved product of its own. This page covers the dose the pivotal trial used, what research-sold blend vials describe, and where Novo Nordisk’s approval filing stands. For each compound on its own, see the cagrilintide guide and the semaglutide guide.
US legal status - Research use only
Semaglutide alone is FDA-approved as Ozempic, Wegovy and Rybelsus. CagriSema, the cagrilintide/semaglutide combination, has no FDA-approved product; Novo Nordisk has an application under review.
AU legal status - Not on the ARTG
Semaglutide alone is on the ARTG as a prescription medicine. CagriSema is not an approved combination product in Australia.
Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.
CagriSema dosage: the REDEFINE 1 trial dose
A randomised, double-blind, placebo-controlled Phase 3a trial in adults with overweight or obesity, REDEFINE 1 Garvey 2025 - 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(7):635-647., in the references below, tested CagriSema at its target maintenance dose:
| Arm | Dose | Schedule | Duration |
|---|---|---|---|
| CagriSema | 2.4 mg cagrilintide + 2.4 mg semaglutide | Once weekly, subcutaneous, reached by escalation | 68 weeks |
| Semaglutide alone | 2.4 mg | Once weekly, subcutaneous | 68 weeks |
| Cagrilintide alone | 2.4 mg | Once weekly, subcutaneous | 68 weeks |
| Placebo | - | Once weekly, subcutaneous | 68 weeks |
The trial reported an estimated mean body-weight change of -20.4% with CagriSema versus -3.0% with placebo at week 68 Garvey 2025 - 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(7):635-647., in the references below. Gastrointestinal adverse events, mostly transient and mild-to-moderate, affected a large majority of the CagriSema group versus a minority on placebo. That is what this trial measured in its own monitored participants. It is not a dose this page recommends for anyone outside it.
What is in a research-sold CagriSema vial
CagriSema is not sold as a legitimate consumer product anywhere. The approved-drug pathway does not exist yet, and any vial marketed directly to consumers as research CagriSema is outside that pathway, whatever its label says.
Two independent dosing-guide sites describe the same shape of product:
- Peptide Dosing Protocols describes a pre-blended vial of 20 mg total: 10 mg cagrilintide plus 10 mg semaglutide, a 1:1 ratio. It reaches a weekly maintenance target of 2.4 mg of each. The titration schedule is 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, then 2.4 mg of each, matching REDEFINE 1’s own escalation.
- Peptide Protocol Wiki independently describes a smaller 10 mg vial, reconstituted to reach the same 2.4 mg weekly target dose over a similar 16-20 week escalation.
Both sources are non-clinical, non-regulatory sites reporting current practice, not a lab-verified or FDA-reviewed product.
CagriSema (cagrilintide + semaglutide, 1:1) 20 mg vial
| Water added | Concentration | 1 unit = | 500 mcg | 1 mg | 2 mg | 3.4 mg | 4.8 mg |
|---|---|---|---|---|---|---|---|
| 2 mL water | 10 mg/mL | 100 mcg | 5 units | 10 units | 20 units | 34 units | 48 units |
| 2.5 mL water | 8 mg/mL | 80 mcg | 6.5 units | 12.5 units | 25 units | 42.5 units | 60 units |
| 3 mL water | 6.67 mg/mL | 66.67 mcg | 7.5 units | 15 units | 30 units | 51 units | 72 units |
Units on a U-100 insulin syringe (100 units = 1 mL), to the nearest half unit. Doses are the combined cagrilintide+semaglutide total for each REDEFINE 1-matched escalation step (0.25/0.25 mg through 2.4/2.4 mg weekly), per Peptide Dosing Protocols' 20 mg (10 mg + 10 mg) vial - not a finding from any trial and not a recommendation.
Why cagrilintide and semaglutide are combined
The two compounds act on different receptors. Cagrilintide is an amylin-receptor agonist, and semaglutide is a GLP-1 receptor agonist.
REDEFINE 1 Garvey 2025 - 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(7):635-647., in the references below directly tested whether combining them adds up to more weight loss than either alone. It ran semaglutide-only and cagrilintide-only arms alongside CagriSema, and reported a larger estimated mean weight change with the combination than with either component arm. Unlike the other two blend pages on this site, this is not an untested pairing. A Phase 3 trial was built to measure this combination, at the exact dose this page reports above.
Side effects of each component
REDEFINE 1 reported gastrointestinal adverse events in a large majority of the CagriSema group, versus a minority on placebo Garvey 2025 - 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(7):635-647., in the references below. They were nausea, vomiting, diarrhoea, constipation and abdominal pain, described as mostly transient and mild-to-moderate.
For each component’s own side-effect record, see the cagrilintide guide and the semaglutide guide. They cover the FDA-reviewed data for approved semaglutide, the separate Phase 2 trial data for cagrilintide alone, and each compound’s adverse-event profile in full.
Novo Nordisk’s FDA filing status
Novo Nordisk announced it had submitted a New Drug Application to the FDA for CagriSema on 18 December 2025. It covers the 2.4 mg cagrilintide/2.4 mg semaglutide fixed-dose combination. Novo Nordisk said it expects the agency’s review to complete in 2026.
As of this writing, no decision has been made public. A filing is a request for approval, not approval. The timeline is company-reported, because FDA does not publish pending-review dates itself.
How do I work out reconstitution and injection volume?
That is arithmetic specific to a vial’s concentration and diluent, which this page cannot know for you. Use the dosage calculator to work through the math for your own vial. It performs the calculation. It does not choose a dose.
Who should not use it
No FDA-reviewed contraindication list exists for CagriSema, because it has never completed FDA review. REDEFINE 1 excluded people with diabetes.
As general context, semaglutide’s approved labels carry a boxed warning about thyroid C-cell tumours seen in rodent studies. They say it should not be used by anyone with a personal or family history of medullary thyroid carcinoma or MEN 2. That is a warning on the approved drug, not evidence about the unapproved combination, but it is relevant background given the shared molecule. Nobody should self-direct an unapproved research-sold vial around pregnancy, breastfeeding or any diagnosed condition.
Risks
Beyond the REDEFINE 1 trial’s own monitored population, there is no long-term human safety data for CagriSema as a combination and no FDA-reviewed label. There is also no verified content or purity for a vial sold outside the approved-drug system. A vial’s stated 10 mg/10 mg content is the seller’s claim, not an independently confirmed figure.
Related
- Cagrilintide: what the research shows
- Semaglutide: the approved label
- Cagrilintide dosage: the Phase 2 trial doses
- Semaglutide dosage: the approved label
- Dosage calculator
Common questions
What is CagriSema?
CagriSema is Novo Nordisk's investigational name for a fixed-dose combination of cagrilintide, an amylin-receptor agonist, and semaglutide, a GLP-1 receptor agonist, given as one weekly subcutaneous injection. It is the combination studied in the company's REDEFINE trial program, and no approved product exists.
What dose did the REDEFINE 1 trial use?
This randomised, double-blind, placebo-controlled Phase 3a trial in adults with overweight or obesity targeted 2.4 mg cagrilintide plus 2.4 mg semaglutide, once weekly. The dose was reached by escalation over the first 16 weeks, then continued for a 68-week treatment period.
Is CagriSema FDA-approved?
No. Novo Nordisk submitted a New Drug Application to the FDA on 18 December 2025 for CagriSema 2.4 mg/2.4 mg. It has said it expects the agency to complete its review in 2026. A filing is a request for approval, not approval. No decision has been made public as of this writing.
Why are cagrilintide and semaglutide combined?
They act on two different receptors: cagrilintide on the amylin receptor, semaglutide on the GLP-1 receptor. The REDEFINE 1 trial found the combination produced significantly more weight loss than placebo. That trial is the basis for combining them, not a claim this page makes independently.
Is CagriSema legal?
Semaglutide alone is FDA-approved as Ozempic, Wegovy and Rybelsus, each requiring a prescription. Cagrilintide alone and CagriSema as a combination have no FDA-approved product. A vial sold as research CagriSema is neither the approved semaglutide product nor an approved combination, whatever its label says.
What are the side effects of CagriSema?
The REDEFINE 1 trial reported gastrointestinal adverse events in the large majority of participants on CagriSema, mostly transient and mild-to-moderate. Full side-effect detail for each component, including FDA-reviewed data for semaglutide, is on the individual compound pages.
When should I stop and get medical care?
Get emergency care (call 911 in the US) for signs of a severe allergic reaction, severe or persistent vomiting with signs of dehydration, or severe abdominal pain. Call Poison Control at 1-800-222-1222 if you have taken an unknown or excessive amount of anything sold as cagrilintide, semaglutide or CagriSema. This page is not a substitute for a clinician who knows your history.
Is CagriSema better than semaglutide?
For weight loss, REDEFINE 1 ran a semaglutide 2.4 mg arm alongside CagriSema. It reported a larger mean weight change with the combination than with semaglutide alone, though its primary comparison was against placebo. Gastrointestinal side effects affected most CagriSema participants. Semaglutide is FDA-approved and CagriSema is not. A research-sold blend vial is not the trial drug.
When will CagriSema be available in the USA?
Only once FDA approves it, and that has not happened as of this writing. Novo Nordisk submitted a New Drug Application on 18 December 2025 and has said it expects FDA to complete its review in 2026. That timeline is company-reported. Until then, anything sold as CagriSema in the US is an unreviewed research product, not the trial drug.
Is CagriSema tirzepatide?
No. CagriSema is Novo Nordisk's combination of cagrilintide (an amylin-receptor agonist) and semaglutide (a GLP-1 receptor agonist). Tirzepatide is a single, different molecule that activates the GIP and GLP-1 receptors, made by Eli Lilly and FDA-approved as Mounjaro and Zepbound. See the [tirzepatide guide](/tirzepatide/).
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 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(7):635-647.Randomised trialPMID 40544433
- 2.Novo Nordisk - PR Newswire release announcing the FDA filing for CagriSema (cagrilintide 2.4 mg/semaglutide 2.4 mg), submitted 18 December 2025, with FDA review expected in 2026.- Novo Nordisk (via PR Newswire)regulatory
- 3.Peptide Dosing Protocols- peptidedosingprotocols.comother
- 4.Peptide Protocol Wiki- peptideprotocolwiki.comother