How is CagriSema dosed?
CagriSema has an FDA New Drug Application under review but no approved product and no prescribing information yet, so there is no label schedule to read. This page reads the Phase 2 and Phase 3 REDEFINE and REIMAGINE trial doses directly instead — the NCT number, phase, enrollment, and arms for each trial, with the adverse events reported alongside the dose that produced them.
Topic: Reading CagriSema’s trial doses directly, since no label exists yet
Audience: Anyone comparing a CagriSema dose figure against its actual trial source
Reading time: 9–11 minutes
No approved product exists — an NDA is under FDA review
CagriSema has not been approved by the FDA, EMA, or any other major regulatory body, under any brand name, for any indication. Novo Nordisk filed a New Drug Application with the FDA in December 2025 for chronic weight management, based primarily on the REDEFINE 1 and REDEFINE 2 trials, with a decision expected in late 2026. That is a materially different position from a compound with no filing at all — but it is still not an approval. There is no prescribing information, no boxed warning, and no approved dosage to defer to. Every figure on this page is a fact about a specific clinical trial — not a recommendation.
On this page
What CagriSema is, and what it isn’t
CagriSema is Novo Nordisk’s investigational fixed-dose combination of cagrilintide, an amylin receptor agonist, and semaglutide, a GLP-1 receptor agonist, co-titrated in a 1:1 ratio in a single once-weekly injection. It has been studied across obesity, overweight, and type 2 diabetes in the REDEFINE and REIMAGINE Phase 3 programs. None of that trial activity has produced an approved product yet: as of this page’s build, CagriSema has no brand name and no FDA approval decision, though its NDA is under active review.
That is a different regulatory position from survodutide and retatrutide, neither of which has any FDA filing at all — but the structural reason this page reads differently from Mounjaro’s or Ozempic’s label pages is the same: there is still no prescribing information to read, so what follows is a report of what each trial itself administered and found, not a schedule. The CagriSema profile covers the mechanism and broader research areas in more depth; this page exists specifically to read the trial doses and their reported adverse events side by side.
What the trials administered
Five trials met the bar for inclusion here: each has a checkable NCT number, a published phase, enrollment, and dose arms, and a result attributable to a specific document. Each trial is graded against Prof. Peptide’s standing citation convention — a claim is attributed when it resolves to a named, checkable source. Four of the five are peer-reviewed publications; the fifth, REDEFINE 4, is reported as a topline company announcement because no peer-reviewed publication of it was found as of this page’s build — and its result runs the other way: CagriSema did not beat tirzepatide.
Phase 2 — Type 2 Diabetes
NCT04982575Frias JP, Deenadayalan S, Erichsen L, et al. Lancet. 2023;402(10403):720–730.
Design: 32-week, multicenter, double-blind, active-controlled, phase 2 trial across 17 sites in the USA, in adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor.
Arms: 92 participants (matches the registry's actual enrollment) randomized 1:1:1 to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide, each escalated to 2.4 mg.
Endpoint reported: Mean HbA1c change at week 32: −2.2 percentage points (CagriSema) versus −1.8 (semaglutide, not statistically significant, P=0.075) and −0.9 (cagrilintide, P<0.0001). Mean body-weight change: −15.6% (CagriSema) versus −5.1% (semaglutide, P<0.0001) and −8.1% (cagrilintide, P<0.0001).
Adverse events reported at these doses: Adverse events were reported by 68% (CagriSema), 71% (semaglutide), and 80% (cagrilintide) of participants — mild or moderate gastrointestinal events were most common; no level 2 or 3 hypoglycemia and no fatal adverse events were reported in any group.
Attributed — published in a peer-reviewed journal, registered with a checkable NCT number, phase/N/arms independently confirmed against the ClinicalTrials.gov record.
REDEFINE 1 — Phase 3, Obesity/Overweight
NCT05567796Garvey WT, Blüher M, Osorto Contreras CK, et al. N Engl J Med. 2025;393(7):635–647.
Design: Phase 3a, 68-week, multicenter, double-blind, placebo-controlled and active-controlled trial in adults without diabetes who had a BMI of 30 or higher, or 27 or higher with at least one obesity-related complication. Effect estimates used the treatment-policy estimand.
Arms: 3,417 participants randomized 21:3:3:7 (2,108 to CagriSema, 302 to semaglutide alone, 302 to cagrilintide alone, 705 to placebo), each active arm at 2.4 mg, alongside lifestyle intervention for all groups.
Endpoint reported: Mean body-weight change at week 68 (treatment-policy estimand): −20.4% (CagriSema) versus −3.0% (placebo), estimated difference −17.3 percentage points (95% CI −18.1 to −16.6), P<0.001. CagriSema participants were more likely to reach 5%, 20%, 25%, and 30%-or-more weight-loss targets (P<0.001 for all).
Adverse events reported at these doses: Gastrointestinal adverse events (nausea, vomiting, diarrhea, constipation, abdominal pain) affected 79.6% of the CagriSema group versus 39.9% on placebo — mainly transient and mild-to-moderate.
Attributed — published in a peer-reviewed journal (NEJM, 2025), registered with a checkable NCT number, phase/N/arms independently confirmed against the ClinicalTrials.gov record. This is the trial cited in Novo Nordisk's December 2025 FDA NDA submission.
REDEFINE 2 — Phase 3, Obesity/Overweight + Type 2 Diabetes
NCT05394519Davies MJ, Bajaj HS, Broholm C, et al. N Engl J Med. 2025;393(7):648–659.
Design: Phase 3a, 68-week, double-blind, randomized, placebo-controlled trial in 12 countries, in adults with a BMI of 27 or higher, HbA1c 7–10%, and type 2 diabetes. Effect estimates used the treatment-policy estimand.
Arms: 1,206 participants randomized 3:1 to once-weekly CagriSema 2.4 mg/2.4 mg (904 participants) or placebo (302 participants), alongside lifestyle intervention.
Endpoint reported: Mean body-weight change at week 68: −13.7% (CagriSema) versus −3.4% (placebo), estimated difference −10.4 percentage points (95% CI −11.2 to −9.5), P<0.001. 73.5% of the CagriSema group reached an HbA1c of 6.5% or lower, versus 15.9% on placebo.
Adverse events reported at these doses: Gastrointestinal adverse events were reported by 72.5% of the CagriSema group versus 34.4% on placebo, most transient and mild-to-moderate.
Attributed — published in a peer-reviewed journal (NEJM, 2025), registered with a checkable NCT number, phase/N/arms independently confirmed against the ClinicalTrials.gov record.
REIMAGINE 2 — Phase 3, Type 2 Diabetes vs. Semaglutide and Cagrilintide
NCT06065540Buse JB, Bajaj HS, Dalskov SM, et al. Lancet Diabetes Endocrinol. 2026;14(8):662–677.
Design: Phase 3, 68-week, randomized, double-blind, placebo-controlled and active-controlled, parallel-group trial in 30 countries, in adults with inadequately controlled type 2 diabetes (HbA1c 7.0–10.5%) on metformin with or without an SGLT2 inhibitor, BMI 25 or higher.
Arms: 2,713 participants randomized 8:8:2:8:8:1:1 to CagriSema 2.4 mg/2.4 mg (n=603), semaglutide 2.4 mg (n=605), cagrilintide 2.4 mg (n=152), CagriSema 1.0 mg/1.0 mg (n=595), semaglutide 1.0 mg (n=609), or corresponding placebo (n=149).
Endpoint reported: Primary endpoint (efficacy estimand): mean HbA1c change at week 68 was −1.91 percentage points with CagriSema 2.4 mg/2.4 mg versus −1.75 with semaglutide 2.4 mg, estimated treatment difference −0.16 percentage points (95% CI −0.27 to −0.05), P=0.0035 — CagriSema was superior to semaglutide alone on this endpoint.
Adverse events reported at these doses: Adverse events were reported by 86.9% of the CagriSema 2.4 mg/2.4 mg group versus 81.2% (semaglutide 2.4 mg), 82.2% (cagrilintide 2.4 mg), and 70.5% (placebo) — the most common were gastrointestinal disorders across all active arms.
Attributed — published in a peer-reviewed journal (Lancet Diabetes & Endocrinology, 2026), registered with a checkable NCT number, phase/N/arms independently confirmed against the ClinicalTrials.gov record.
REDEFINE 4 — Phase 3, Head-to-Head vs. Tirzepatide
NCT06131437Novo Nordisk company announcement (topline results); no peer-reviewed publication found as of this page's build.
Design: 84-week, open-label, randomized, active-controlled Phase 3 trial in adults with obesity and at least one comorbidity, with a 16-week dose-escalation period for CagriSema and a 20-week escalation for tirzepatide.
Arms: 809 participants (matches the registry's actual enrollment) randomized to once-weekly CagriSema 2.4 mg/2.4 mg or once-weekly tirzepatide 15 mg.
Endpoint reported: Primary objective (noninferiority to tirzepatide on percent weight loss at week 84) was NOT met. Efficacy estimand: 23.0% (CagriSema) versus 25.5% (tirzepatide). Treatment-regimen estimand: 20.2% (CagriSema) versus 23.6% (tirzepatide).
Adverse events reported at these doses: The most common adverse events were gastrointestinal, described in the company's release as mild to moderate and diminishing over time; no per-arm rates were located in a checkable primary source as of this build.
Topline, not yet peer-reviewed — reported here as a company announcement of results, distinct from the four peer-reviewed trials above. Phase/N/design independently confirmed against the ClinicalTrials.gov record; the efficacy and adverse-event figures are attributed to Novo Nordisk's own announcement, not to a published paper.
Four further trials exist in the program but are not given full cards here. NCT06534411 (N=1,023) and NCT06221969 (N=1,024) are two additional completed Phase 3 trials comparing CagriSema against tirzepatide in type 2 diabetes, with no published results yet as of this page’s build. NCT07011667 (N=609) is an ongoing, active-not-recruiting Phase 3 trial studying long-term weight-loss maintenance. REIMAGINE 1 (diet-and-exercise-only type 2 diabetes) and REIMAGINE 3 (add-on to basal insulin) are two further published trials in the wider REIMAGINE program, named here for completeness; their own NCT numbers, N, and arms were not independently re-verified for this page and they are not reported as full cards.
Is there a community-reported dose?
Prof. Peptide looked for a genuinely reportable community dosing convention — a figure attributed to a specific, checkable source describing what researchers or users actually report doing, distinct from the trial data itself. None was found for CagriSema.
Every vendor and blog page found describing a “CagriSema dosing protocol” states the same shape: a 0.25 mg starting dose per component, escalated to 2.4 mg per component over roughly 16 weeks. That figure is not an independent community finding — it is the REDEFINE Phase 3 trials’ own escalation schedule, restated with no source cited on any of the pages that repeat it. Nothing distinct from the trial data above survived as a genuine convention, so nothing is presented as one here.
Compounding and research-grade CagriSema
There is no approved CagriSema product, so there is neither a branded version nor a lawful pharmacy-compounded version of one.
No FDA warning letter specifically naming cagrilintide or CagriSema was found. FDA’s own warning letter on GLP-1 compounding (“GLP-1 Solution,” reference 715883, dated September 9, 2025) names retatrutide, semaglutide, and tirzepatide specifically and states the grounds for their 503A and 503B ineligibility — but does not mention cagrilintide or CagriSema anywhere in its text. This page instead applies section 503A’s published criteria to cagrilintide directly: a bulk drug substance is eligible for compounding only if it complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA’s 503A bulks list. Checked directly against FDA’s own 503A and 503B bulk drug substance list pages on the date this page was built, “cagrilintide” appears on neither list, in any category. Cagrilintide has no USP or NF monograph (it is investigational, with no approved product to be a monograph subject of) and is not itself a component of any FDA-approved drug. None of the three conditions is met.
Semaglutide, the combination’s other component, has its own separate compounding history tied to the FDA drug-shortage listing that applied while Wegovy and Ozempic supply was constrained — a question this site addresses on semaglutide’s own pages. That history does not transfer to CagriSema: the combination itself is not an approved product, so nothing about semaglutide’s own approval opens a compounding pathway for the fixed-dose pairing. The situation is structurally the same one the survodutide guide describes for an investigational compound with no approved product of its own, reached here independently rather than by citing the same letter.
Research-grade cagrilintide and semaglutide, including pre-blended 1:1 combination vials of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, are not compounded drug products and not branded products — those categories don’t apply to them at all. They are sold labeled for laboratory research use, not for human administration, and are not dispensed against a prescription.
FAQ
Is CagriSema FDA-approved?
What dose did the Phase 3 REDEFINE trials use?
Is there a commonly reported CagriSema starting dose outside the trials?
Did CagriSema beat tirzepatide in a head-to-head trial?
What were the most common side effects in the trials?
Can CagriSema legally be compounded the way semaglutide or tirzepatide once were?
What does Prof. Peptide's own research-grade CagriSema fall under, then?
References
- Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023;402(10403):720–730. ClinicalTrials.gov NCT04982575. https://clinicaltrials.gov/study/NCT04982575
- 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. ClinicalTrials.gov NCT05567796. https://clinicaltrials.gov/study/NCT05567796
- 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(7):648–659. ClinicalTrials.gov NCT05394519. https://clinicaltrials.gov/study/NCT05394519
- Buse JB, Bajaj HS, Dalskov SM, et al. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. Lancet Diabetes Endocrinol. 2026;14(8):662–677. ClinicalTrials.gov NCT06065540. https://clinicaltrials.gov/study/NCT06065540
- ClinicalTrials.gov. A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight (REDEFINE 4). NCT06131437 — topline results per Novo Nordisk company announcement; no peer-reviewed publication found as of this page’s build. https://clinicaltrials.gov/study/NCT06131437
- U.S. Food and Drug Administration. Warning Letter: GLP-1 Solution, reference 715883, 2025-09-09 (names retatrutide, semaglutide, and tirzepatide; does not name cagrilintide or CagriSema). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025
- U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- U.S. Food and Drug Administration. 503B Bulk Drug Substances List. https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list
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