CagriSema
CagriSema is the coadministered pair of cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist, given once weekly by subcutaneous injection in trials. The human evidence fetched for this page is a phase 2 trial and six phase 3 trials from Novo Nordisk; the combination is not approved in the United States, where a new drug application was submitted on December 18, 2025, with FDA review expected in 2026, and its status in other markets was not verified in this research.
Last updated: September 2026
Category
Weight Loss (GLP-1 plus Amylin)
Frequency
Once weekly, subcutaneous (in trials)
Research
Phase 2 and 3 trials, unapprovedWhat is CagriSema?
Novo Nordisk describes CagriSema as a fixed-dose combination of cagrilintide 2.4 mg, a long-acting amylin analogue, and semaglutide 2.4 mg, a GLP-1 receptor agonist, given once weekly by subcutaneous injection (Novo Nordisk release). The name refers to the coadministered pair, not a new single molecule. Those milligram amounts describe the product the sponsor has outlined, not a dose anyone should self-select and not a recommendation: every figure in the dosing table below is a study dose from a specific trial. This page sits alongside the cagrilintide profile in our peptide library, which covers the amylin component on its own.
The fetched evidence is substantial for a compound many people still search by its research name: a phase 2 trial in type 2 diabetes and six phase 3 trials (REDEFINE 1, 2 and 5, and REIMAGINE 1, 2 and 3), all sponsored by Novo Nordisk, spanning obesity with and without diabetes. Every trial gave each component once weekly by subcutaneous injection at 2.4 mg, and the three REIMAGINE trials also studied a lower 1.0 mg plus 1.0 mg level (trial doses, not recommendations; the PubMed ID behind each sits in the dosing table below).
It is not an approved medicine. Novo Nordisk submitted a United States new drug application on December 18, 2025, with FDA review expected in 2026 (Novo Nordisk release), and the openFDA database lists no approved product or prescribing label under cagrilintide or cagrisema as of this research (openFDA). Regulatory status in the European Union and Vietnam could not be verified here because those databases were unreachable, so this page makes no claim either way. Because it is unapproved and unlabelled, every dose below is a trial-administered study dose, never a recommendation.
How It Works
Amylin pathway (cagrilintide): amylin, released with insulin from pancreatic beta cells, produces a satiating effect through both the homeostatic and hedonic regions of the brain, and cagrilintide is a long-acting analogue of it (narrative review, PMID 36883831).
GLP-1 pathway (semaglutide): semaglutide, a GLP-1 receptor agonist, reduces appetite through GLP-1 receptors in the hypothalamus, increases insulin production, reduces glucagon secretion, and delays gastric emptying (narrative review, PMID 36883831).
Why combine them: reviewers describe these separate but related mechanisms as having an additive effect on appetite reduction, which is the stated rationale for pairing an amylin analogue with a GLP-1 receptor agonist (narrative review, PMID 36883831).
How it was given: in every fetched trial the two were injected together once weekly under the skin; the phase 2 and REDEFINE 5 reports describe treatment escalated to 2.4 mg of each component (PMID 37364590, PMID 42009015), and the REIMAGINE trials also studied 1.0 mg of each (PMID 42251860, PMID 42251859, PMID 42251856), all trial-administered study doses and not recommendations.
What the Trials Reported
- Weight loss without diabetes: in REDEFINE 1, mean body weight fell 20.4% versus 3.0% on placebo at 68 weeks under the treatment-policy estimand (phase 3a trial, PMID 40544433). Novo Nordisk reports the same trial as an average 23% under a different estimand (Novo Nordisk release), so the headline figure depends on how it is counted.
- Weight loss with type 2 diabetes: REDEFINE 2 reported a 13.7% reduction versus 3.4% on placebo at 68 weeks, the smaller response usually seen in diabetes (phase 3a trial, PMID 40544432).
- Blood sugar: in REDEFINE 2, 73.5% of the combination group reached an HbA1c of 6.5% or lower versus 15.9% on placebo (phase 3a trial, PMID 40544432).
- In an East Asian population: REDEFINE 5, run in Japan and Taiwan, reported 18.4% body weight loss versus 11.9% on semaglutide alone at 68 weeks under the trial product estimand (phase 3a trial, PMID 42009015).
- Against semaglutide on blood sugar: in REIMAGINE 2, a large type 2 diabetes trial (n=2713) with a direct semaglutide comparison, HbA1c fell 0.16 percentage points more than with semaglutide alone: statistically significant (p=0.0035) but a small margin (phase 3 trial, PMID 42251859).
- In a pooled analysis: a network meta-analysis ranked the combination highest for weight loss at 14.03 kg, ahead of tirzepatide at 8.47 kg, but by indirect comparison rather than a head-to-head trial (network meta-analysis, PMID 38286487).
Doses Studied in the Trials
| Phase | Dose | Frequency | Duration |
|---|---|---|---|
| REDEFINE 1: obesity or overweight, no diabetes | cagrilintide 2.4 mg plus semaglutide 2.4 mg (trial dose, not a recommendation, PMID 40544433) | Once weekly, subcutaneous | 68 weeks, phase 3a, n=3417 (NCT05567796) |
| REDEFINE 2: overweight or obesity with type 2 diabetes | cagrilintide 2.4 mg plus semaglutide 2.4 mg (trial dose, not a recommendation, PMID 40544432) | Once weekly, subcutaneous | 68 weeks, phase 3a, n=1206 (NCT05394519) |
| Phase 2: type 2 diabetes on metformin | escalated to cagrilintide 2.4 mg plus semaglutide 2.4 mg (trial dose, not a recommendation, PMID 37364590) | Once weekly, subcutaneous | 32 weeks, phase 2, n=92 (NCT04982575) |
| REDEFINE 5: Japan and Taiwan, with or without diabetes | escalated to cagrilintide 2.4 mg plus semaglutide 2.4 mg (trial dose, not a recommendation, PMID 42009015) | Once weekly, subcutaneous | 68 weeks, phase 3a, n=331 (NCT05813925) |
| REIMAGINE 2: type 2 diabetes on metformin | cagrilintide 2.4 mg plus semaglutide 2.4 mg, or 1.0 mg of each (trial dose, not a recommendation, PMID 42251859) | Once weekly, subcutaneous | 68 weeks, phase 3, n=2713 (NCT06065540) |
| REIMAGINE 1: early type 2 diabetes, diet and exercise | cagrilintide 2.4 mg plus semaglutide 2.4 mg, or 1.0 mg of each (trial dose, not a recommendation, PMID 42251860) | Once weekly, subcutaneous | 40 weeks, phase 3a, n=189 (NCT06323174) |
| REIMAGINE 3: add-on to basal insulin | cagrilintide 2.4 mg plus semaglutide 2.4 mg, or 1.0 mg of each (trial dose, not a recommendation, PMID 42251856) | Once weekly, subcutaneous | 40 weeks, phase 3a, n=274 (NCT06323161) |
These are the once-weekly subcutaneous doses administered in the published trials, with the PubMed ID behind each figure. CagriSema is not approved and has no prescribing label, so these are study doses, not a recommendation or a personal protocol. Any dose, schedule, or decision to use a compound belongs with a licensed prescriber.
Side Effects
Common
- ⚠Gastrointestinal events were the most common in every trial. In REDEFINE 1 they affected 79.6% of the combination group versus 39.9% on placebo, mainly transient and mild to moderate (PMID 40544433).
- ⚠In REDEFINE 1, the sponsor itemised nausea at 55% versus 12.6% on placebo, constipation at 30.7% versus 11.6%, and vomiting at 26.1% versus 4.1% (Novo Nordisk release).
- ⚠In REDEFINE 2 (with type 2 diabetes), gastrointestinal events were reported by 72.5% versus 34.4% on placebo, most transient and mild or moderate (PMID 40544432).
- ⚠A meta-analysis found gastrointestinal events and vomiting were significantly higher with CagriSema than with semaglutide alone (PMID 39676787).
Rare
- •Hypoglycaemia was not a prominent signal: the phase 2 trial reported no level 2 or 3 hypoglycaemia (PMID 37364590), and REIMAGINE 3 reported no additional risk of hypoglycaemia when the combination was added to basal insulin (PMID 42251856).
- •The deaths recorded in these trials were judged not related to treatment: one in the semaglutide arm of REDEFINE 5, and one in the 1.0 mg combination arm of REIMAGINE 3, attributed to malignancy (PMID 42009015, PMID 42251856).
- •Discontinuation due to adverse events in REDEFINE 1 was low, 5.9% for the combination versus 3.5% on placebo (Novo Nordisk release).
What This Evidence Does Not Cover
- ✕People outside a clinical trial or a prescriber’s care: CagriSema is an investigational combination, not an approved medicine, so nothing here is a use instruction (Novo Nordisk new drug application submitted December 18, 2025, with FDA review expected in 2026; openFDA lists no product).
- ✕Children and adolescents: the fetched trials enrolled adults, and those that state an age floor set it at 18, so this page carries no data for anyone younger.
- ✕Pregnant or breastfeeding people: the fetched trial abstracts report no data in these groups, so this page makes no claim for them.
- ✕Anyone looking for a settled maintenance dose: the trials studied fixed levels, 2.4 mg of each component and 1.0 mg of each in the REIMAGINE trials, all study doses and none an approved or recommended dose (see the dosing table).
How the Trials Ran
The components were titrated upward rather than started at full strength: the phase 2 and REDEFINE 5 reports describe treatment escalated to 2.4 mg of each (PMID 37364590, PMID 42009015). The abstracts do not give the week-by-week titration schedule, so this page does not state one.
The shorter trials read out here. The phase 2 diabetes trial ran 32 weeks (PMID 37364590); REIMAGINE 1 and REIMAGINE 3 ran 40 weeks (PMID 42251860, PMID 42251856).
The long obesity and diabetes trials measured their primary endpoints at 68 weeks: REDEFINE 1, REDEFINE 2, REDEFINE 5 and REIMAGINE 2 (PMID 40544433, PMID 40544432, PMID 42009015, PMID 42251859).
The phase 2 trial, REDEFINE 5 and the three REIMAGINE trials state they are complete; Novo Nordisk submitted a US new drug application on December 18, 2025, with FDA review expected in 2026 (Novo Nordisk release). This research found no approved maintenance schedule and no long-term real-world data.
Notes from Ho Chi Minh City
The Ho Chi Minh City angle on CagriSema is mostly about what is not here yet. Search Long Chau, the largest chain, and you get zero results for cagrisema and for cagrilintide, while semaglutide sits on the shelf as Ozempic, a registered prescription product with a marketing authorisation number (Long Chau). So the combination people read about is not the combination sold in District 1: it is an investigational pairing still moving through trials and, as of December 2025, a US FDA new drug application (Novo Nordisk release). The closest read for an East Asian patient is REDEFINE 5, run in Japan and Taiwan, where the combination reduced body weight 18.4% versus 11.9% on semaglutide alone over 68 weeks (PMID 42009015). Whether and when it reaches Vietnamese pharmacies is a regulatory question this page cannot answer, because the Drug Administration of Vietnam database was unreachable when this was researched, so no registration status is claimed in either direction. Any decision about GLP-1 or amylin therapy belongs with a licensed prescriber, not a search result.
Sourcing in Vietnam
CagriSema is not stocked at any Vietnamese pharmacy this research could check. A Long Chau search returns zero products for cagrisema and for cagrilintide, against 291 for semaglutide, and the semaglutide control returns real listings including Ozempic, which is what makes the two zero counts a genuine result rather than a search glitch (Long Chau). Pharmacity and An Khang could not be reached from the research host, so their listings are unknown, not confirmed absent. There is no approved product and no prescribing label for CagriSema anywhere this research verified (openFDA), so there is no legitimate retail price to quote: no published figure. This page researched no research-chemical vendor and makes no claim, in either direction, about grey-market CagriSema sold as a powder, its purity, or its sourcing.
FAQ
Q: Is CagriSema approved or available to buy in Vietnam?
A: As of this research, no. CagriSema is not an approved medicine: Novo Nordisk submitted a US new drug application on December 18, 2025, with FDA review expected in 2026 (Novo Nordisk release), and the openFDA database lists no product or label under either name. A search of Long Chau, the largest Vietnamese chain, returns zero results for cagrisema and for cagrilintide, against 291 for semaglutide, so the combination is genuinely not listed there. Its registration status with the Drug Administration of Vietnam could not be verified because that database was unreachable during this research, so this page makes no claim either way. Semaglutide alone is separately registered and sold on prescription in Vietnam; see the semaglutide in Vietnam guide.
Q: How much weight did people lose in the CagriSema trials?
A: It depends on the population and on how the number is calculated. In REDEFINE 1 (obesity or overweight, no diabetes), mean body weight fell 20.4% versus 3.0% on placebo at 68 weeks under the treatment-policy estimand (PMID 40544433); Novo Nordisk reports the same trial as an average 23% under a different estimand (Novo Nordisk release). In REDEFINE 2 (with type 2 diabetes) the figure was 13.7% versus 3.4% on placebo (PMID 40544432). Reviews place the combination in the 15 to 25% weight-loss range described for newer agents (review, PMID 40865172). These are trial results, not a personal prediction.
Q: Is CagriSema better than semaglutide or tirzepatide?
A: Against semaglutide, the trials point one way: REDEFINE 5 reported 18.4% versus 11.9% body weight loss over 68 weeks (PMID 42009015), and REIMAGINE 2 found a small 0.16 percentage point edge on HbA1c (PMID 42251859). Against tirzepatide the honest answer is that there is no head-to-head trial in this research: the only comparison is indirect, through a network meta-analysis that ranked CagriSema first for weight loss (14.03 kg versus 8.47 kg for tirzepatide, PMID 38286487). An indirect ranking is not the same as a trial that randomised people to one drug or the other.
Q: What are the most common side effects reported?
A: Gastrointestinal events, in every trial. In REDEFINE 1 they affected 79.6% of the combination group versus 39.9% on placebo, mainly transient and mild to moderate (PMID 40544433); the sponsor itemised nausea at 55% versus 12.6%, constipation at 30.7% versus 11.6%, and vomiting at 26.1% versus 4.1% (Novo Nordisk release). A meta-analysis found gastrointestinal events and vomiting were significantly higher with CagriSema than with semaglutide alone (PMID 39676787). Discontinuation due to adverse events in REDEFINE 1 was low, 5.9% versus 3.5% on placebo (Novo Nordisk release).
Q: How is CagriSema related to cagrilintide and semaglutide, and is it a peptide?
A: CagriSema is the two drugs given together, not a new molecule: cagrilintide, a long-acting amylin analogue, plus semaglutide, a GLP-1 receptor agonist (Novo Nordisk release). See our cagrilintide profile for the amylin component on its own. On the peptide question, the fetched sources describe them as an amylin analogue and a GLP-1 receptor agonist and record their molecular weights (cagrilintide about 4409, semaglutide about 4114, PubChem), but do not use the word peptide for either, so this page describes them the way the sources do rather than labelling them.
Where to Get CagriSema in Vietnam
CagriSema is not approved and is not listed by any Vietnamese pharmacy this research could check. A Long Chau search returns zero products for cagrisema and for cagrilintide, against 291 for semaglutide, so the combination is genuinely not on that chain. There is no legitimate retail source or price to quote for it. Semaglutide, one of its two components, is separately registered and sold on prescription; the pages below cover that.
Related Peptides
Related Guides
Research & Sources
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity · New England Journal of Medicine (2025) (PMID: 40544433)
REDEFINE 1. Phase 3a, 68 weeks, n=3417, registry NCT05567796. Body weight fell 20.4% with the combination versus 3.0% with placebo at week 68 (treatment-policy estimand). Gastrointestinal adverse events affected 79.6% versus 39.9% on placebo.
- Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes · New England Journal of Medicine (2025) (PMID: 40544432)
REDEFINE 2. Phase 3a, 68 weeks, n=1206, 12 countries, registry NCT05394519. Body weight fell 13.7% versus 3.4% on placebo; 73.5% reached HbA1c 6.5% or lower versus 15.9% on placebo.
- 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 · The Lancet (2023) (PMID: 37364590)
Phase 2 in type 2 diabetes. 32 weeks, 17 US sites, n=92, registry NCT04982575. All arms escalated to 2.4 mg. No level 2 or 3 hypoglycaemia and no fatal adverse events reported.
- Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial · The Lancet Diabetes & Endocrinology (2026) (PMID: 42009015)
REDEFINE 5. 68 weeks, 21 sites in Japan and one in Taiwan, n=331, registry NCT05813925. Body weight fell 18.4% versus 11.9% on semaglutide alone (trial product estimand). The only fetched trial in an East Asian population.
- Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study · The Lancet Diabetes & Endocrinology (2026) (PMID: 42251859)
REIMAGINE 2. 68 weeks, 30 countries, n=2713, registry NCT06065540. HbA1c fell 1.91 versus 1.75 percentage points for semaglutide 2.4 mg, a difference of 0.16 percentage points (p=0.0035): significant but small.
- Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study · The Lancet Diabetes & Endocrinology (2026) (PMID: 42251860)
REIMAGINE 1. 40 weeks, 42 sites in six countries, n=189, registry NCT06323174. Studied 2.4 mg of each and 1.0 mg of each versus placebo; body weight fell 13.8% versus 1.4% on placebo at the 2.4 mg level.
- Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study · The Lancet (2026) (PMID: 42251856)
REIMAGINE 3. 40 weeks, 46 centres in six countries, n=274, registry NCT06323161. HbA1c reductions of 2.33% (2.4 mg each) and 2.10% (1.0 mg each) versus 0.66% on placebo; body weight reductions of 10 to 12%. No additional risk of hypoglycaemia.
- Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis · BMJ (2024) (PMID: 38286487)
Network meta-analysis. CagriSema ranked highest for weight loss at 14.03 kg, ahead of tirzepatide at 8.47 kg. Indirect comparison, not a head-to-head trial.
- Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis · Indian Journal of Endocrinology and Metabolism (2024) (PMID: 39676787)
Meta-analysis of 3 RCTs, 430 individuals, 20 to 32 weeks. CagriSema beat semaglutide 2.4 mg by about 9% of body weight and 9 kg, with very high statistical heterogeneity. Gastrointestinal events and vomiting were higher with CagriSema than with semaglutide.
- Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity · Cardiology in Review (2024) (PMID: 36883831)
Narrative review of the amylin analogue mechanism and the additive-appetite-reduction rationale for combining it with semaglutide.
- Weight management treatment in obesity · Medicina Clinica (Barcelona) (2025) (PMID: 40865172)
Review positioning CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) in the 15 to 25% weight-loss range described for newer agents.
- Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management · Novo Nordisk · Novo Nordisk company release (2025) Link
Company release dated December 18, 2025. NDA submitted to the FDA, review expected in 2026. Describes CagriSema as a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, once-weekly subcutaneous. Reports REDEFINE 1 as an average 23% weight loss with 91.9% reaching 5% or more, and itemises adverse events.
- openFDA Drugs@FDA and Drug Label API query for cagrilintide and cagrisema · US Food and Drug Administration · openFDA (2026) Link
Queried 2026-09-06. Drugs@FDA and the drug label API both return NOT_FOUND for cagrilintide and for cagrisema, consistent with no approved US product or prescribing label as of that date.
- PubChem compound records for cagrilintide and semaglutide · PubChem, National Library of Medicine · PubChem PUG REST (2026) Link
Cagrilintide CID 171397054, molecular formula C194H312N54O59S2, molecular weight 4409. Semaglutide CID 56843331, molecular formula C187H291N45O59, molecular weight 4114.
- Nha Thuoc Long Chau product search for cagrisema, cagrilintide and semaglutide · Nha Thuoc Long Chau (2026) Link
Queried 2026-09-06. Zero products for cagrisema and for cagrilintide; 291 products for the semaglutide control, including Ozempic. A genuine null: Long Chau does not list CagriSema.
- Thuoc tiem Ozempic 1mg, Nha Thuoc Long Chau product page · Nha Thuoc Long Chau (2026) Link
Semaglutide product, not CagriSema. Recorded for Vietnamese terminology and to show a registered semaglutide listing (marketing authorisation number 570410174600, prescription only). Included for contrast only.
Important Disclaimer
Educational content only, not medical advice. CagriSema is an investigational combination of cagrilintide and semaglutide. It is not an approved medicine in the United States, where a new drug application was submitted on December 18, 2025, with FDA review expected in 2026, and this research could not reach the Vietnamese (DAV) or European (EMA) drug databases, so it makes no claim about registration in those markets in either direction. CagriSema is not listed by Long Chau, the largest Vietnamese pharmacy chain checked. Doses shown are study doses from clinical trials, not prescribing instructions. Consult a licensed physician before any use.