CagriSema
An unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results.
Also called: Cagrilintide/semaglutide, Cagrilintide-semaglutide, CagriSema 2.4 mg/2.4 mg.
Amylin analogues · Combination of an amylin analogue and a GLP-1 receptor agonist.
What CagriSema does
CagriSema combines cagrilintide with semaglutide in a weekly injection. Large trials found greater weight loss than placebo, with separate studies in type 2 diabetes. The combination remains investigational as of October 18, 2026. Stomach symptoms are common; semaglutide's boxed warning describes thyroid C-cell tumors in rodents, with unknown human relevance. Home-mixed blends are not the trial product.
- In large trials, people lost more weight than on placebo, and more than on semaglutide alone in an East Asian trial. (Studied in a trial)
- In people with type 2 diabetes, trials found lower blood sugar (HbA1c) and weight, including when added to insulin. (Studied in a trial)
- In rats, the combination cut food intake without slowing the body's energy use. (animal)
Uses in the sources
- Studied for adult obesity or overweight with weight-related health conditions. (Studied in a trial) (source)
- Studied for glucose control in type 2 diabetes, including people taking basal insulin. (Studied in a trial) (source)
- Cardiovascular outcomes are under study; a heart-event benefit for this combination is not yet established. (Studied in a trial) (source)
CagriSema dosage
Typical reported dose: 0.25 mg of each drug weekly to start, up to 2.4 mg of each
- Phase 2: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes and BMI ≥27 on metformin, with or without an SGLT2 inhibitor. (source)
- REDEFINE 1: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults without diabetes: BMI ≥30, or ≥27 with a weight-related condition. (source)
- REDEFINE 2: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes, BMI ≥27 and HbA1c 7–10%. (source)
- REDEFINE 5: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with high BMI and weight-related complications; 24% had type 2 diabetes. (source)
- REIMAGINE 1: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes inadequately controlled by diet and exercise. (source)
- REIMAGINE 3: 2.4 mg of each: 0.25 mg of each drug once weekly, then 0.5 mg of each drug once weekly, then 1 mg of each drug once weekly, then 1.7 mg of each drug once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes on daily basal insulin, with or without metformin. (source)
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
How to mix CagriSema
Comes as: Dual-chamber, single-use prefilled trial pen., Community-reported freeze-dried equal-dose blend vials..
Mixed with: Bacteriostatic water is reported online; no approved reconstitution diluent exists for home blends..
Common vial sizes: 10 mg. Common water amounts: 2 mL.
- A reported 10 mg total vial contains 5 mg of each drug; retain both component amounts.
- A 5 mg + 5 mg vial with 2 mL contains 2.5 mg/mL of each drug, or 5 mg/mL total.
- Online advice about saline, water and acid conflicts. No validated home pH-adjustment procedure was found.
- Trial pens keep the formulations controlled; home co-mixing is not equivalent.
Before mixing: Follow trial-specific instructions for study devices. No validated home-blend storage conditions were found.
After mixing: No validated stability period for home blends was found; a clear solution does not prove sterility.
CagriSema side effects and risks
Reported side effects
- Stomach and bowel symptoms: 79.6% versus 39.9% placebo in REDEFINE 1; 72.5% versus 34.4% in REDEFINE 2., moderate (source)
- Nausea: REIMAGINE 3: 31.1% at 2.4 mg each, 26.9% at 1 mg each, 3.3% placebo., moderate (source)
- Diarrhea: REIMAGINE 3: 15.6%, 10.8% and 3.3%, respectively., moderate (source)
- Vomiting: REIMAGINE 3: 14.4%, 9.7% and 1.1%, respectively., moderate (source)
- Constipation: REIMAGINE 3: 11.1%, 11.8% and 5.5%, respectively., moderate (source)
- Injection-site reactions: 12.2% versus 3.0% placebo in REDEFINE 1., mild (source)
- Gallbladder disorders: 4.1% versus 1.0% placebo in REDEFINE 1., serious (source)
- Pancreatitis: 0.2% versus 0% placebo in REDEFINE 1; 0.3% versus 0% in REDEFINE 2., serious (source)
- Clinically significant low blood sugar: REDEFINE 2: level 2 events 6.0% versus 3.3% placebo., serious (source)
- Severe low blood sugar: REDEFINE 2: 0.2% versus 0%; both affected patients used sulfonylureas., serious (source)
- Dehydration-related kidney injury: Semaglutide component warning; no reliable combination specific rate., serious (source)
- Severe allergic reaction: Semaglutide component postmarketing reports; combination specific rate unknown., serious (source)
Stop and get help if
- Severe persistent belly pain, with or without vomiting: Stop and get urgent assessment for pancreatitis or gallbladder disease.
- Swelling of face or throat, breathing trouble or collapse: Stop and call emergency services.
- Confusion, seizure, unconsciousness or persistent low sugar: Call emergency services; do not give food or drink if unconscious.
- Repeated vomiting, very little urine or severe dizziness: Get urgent assessment for dehydration and kidney injury.
- Sudden vision loss or a new major vision change: Get emergency care for sudden loss of sight; urgent assessment for other new changes.
- Persistent squeezing chest pain, or chest pain with breathlessness: Get emergency assessment.
Who should avoid it
- pregnant: Weight-loss use is unsuitable in pregnancy; semaglutide may harm the fetus.
- breastfeeding: The combination lacks infant safety data; breastfeeding was excluded from trials.
- tryingToConceive: Semaglutide labeling calls for stopping at least 2 months before planned pregnancy.
- under18: Combination dosing in youth is still under study; adult results do not establish safety.
- mtcOrMen2: Semaglutide's label blocks use with personal/family MTC or MEN2. Its boxed warning reports thyroid C-cell tumors in rodents; human relevance is unknown, and CagriSema has no approved label.
- eatingDisorderHistory: Precaution: strong appetite suppression can worsen restrictive eating or poor nutrition.
- gastroparesis: Semaglutide is not recommended with severe gastroparesis.
- pancreatitisHistory: Review prior pancreatitis; cases occurred in combination trials.
- gallbladderDisease: Gallbladder events were more frequent than placebo in REDEFINE trials.
- diabeticRetinopathy: Rapid glucose improvement may worsen existing retinopathy; arrange eye monitoring.
- diabetes: Insulin or sulfonylureas may need clinician adjustment to avoid low blood sugar.
- kidneyDisease: Vomiting or diarrhea can cause dehydration and kidney injury; check kidney function if symptoms persist.
- liverDisease: Component PK data do not establish long-term combination safety in severe liver disease.
- heartCondition: Monitor heart rate and symptoms; combination cardiovascular outcomes are still pending.
- surgeryPlanned: Tell the anesthesia team; delayed stomach emptying can increase aspiration risk.
- testedAthlete: Cagrilintide remains unapproved, so S0 applies; semaglutide monitoring is a separate issue.
- other: Prior serious allergy to semaglutide, cagrilintide or formulation ingredients should stop use.
Interactions
- Insulin and sulfonylureas: Low-sugar risk can rise. Both severe cases in REDEFINE 2 used sulfonylureas; clinician-led dose review matters.
- Extra GLP-1 or amylin drugs: CagriSema already contains semaglutide and cagrilintide. Added GLP-1 or amylin exposure has no established safe schedule.
- Warfarin and other monitored oral drugs: Review INR or drug response during changes. The dedicated warfarin/atorvastatin study is complete but results were not located.
- Oral contraception: Combination absorption data are incomplete. Vomiting or diarrhea can undermine pill use; review backup needs with a clinician.
Product quality risks
- A community “CagriSema” blend is not the controlled dual-chamber trial product.
- Online semaglutide samples had 7.7–14.37% purity, 28.56–38.69% excess content and detectable endotoxin. This was not a CagriSema test.
- Wrong component ratio, vial/unit confusion and contamination can cause harm.
- FDA warns of counterfeit semaglutide products and dosing errors with unapproved injections.
What to expect
- Weeks 1-16: REDEFINE 1 used a 16-week period of gradually increasing weekly doses under trial supervision.
- Weeks 17-68: The trial then continued weekly injections through a 52-week maintenance phase.
- Week 68: REDEFINE 1 found average weight loss of 20.4% versus 3.0% with placebo, with stomach side effects common.
REDEFINE 1 studied weekly cagrilintide plus semaglutide for 68 weeks in adults without diabetes.
33 unique registered combination studies plus one simulated-use pen study. Includes ongoing/unreported records; reviews and secondary analyses are not new trials.
Key studies
- Phase 1b: six combination doses: Early combination testing supported weekly dosing and further trials. (source)
- Combined versus separate injections: Status: completed. No clinical benefit is established by registration. (source)
- Phase 2: combination versus each drug: The combination added weight loss; its HbA1c advantage over semaglutide was not significant. (source)
- MASH trial: exploratory CagriSema arm: This exploratory combination arm did not establish a liver-fibrosis benefit. (source)
- REDEFINE 2: obesity with diabetes: The combination reduced weight and HbA1c in people with type 2 diabetes. (source)
- REDEFINE 1: obesity without diabetes: The combination reduced weight more than placebo; its components also had separate arms. (source)
CagriSema FAQ
- Is CagriSema FDA-approved? No. CagriSema application filed December 2025; no approved combination label found.
- How do people take it? Under the skin, once weekly. 68 weeks. Source: studied in a trial.
- What's the difference between CagriSema and Tirzepatide? CagriSema: an unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results. Tirzepatide: a weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects. Why people pair them: occasional reports add a blend to an existing weight-loss drug.
- Can I take it with Tirzepatide? Occasional reports add a blend to an existing weight-loss drug. Adds GLP-1 exposure to semaglutide already in the blend; no verified human triple-stack evidence. Source: reported by users. Ask a doctor before combining anything.
- Is it banned in sport? Yes. It is banned in and out of competition (WADA 2026). Application of the S0 rule to unapproved cagrilintide; not an individual named listing. Confirm with the athlete’s anti-doping body.
- How long does a mixed vial last? No validated stability period for home blends was found; a clear solution does not prove sterility.
Related to CagriSema
- Cagrilintide: An unapproved weekly amylin analogue with weight-loss trials and common stomach symptoms.
- Pramlintide: A diabetes medicine that copies a hormone released with insulin; Symlin products are discontinued.
- Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
- Nutritional priorities to support GLP-1 therapy for obesity: a joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society., Mozaffarian D et al. · The American journal of clinical nutrition · 2025
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act
- Chest pain, NHS
- European Medicines Agency decision P/0307/2023 of 4 August 2023 on the granting of a product specific waiver for cagrilintide / semaglutide (EMEA-003059-PIP02-23)
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, US Food and Drug Administration
- PIP Search Page, MHRA
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026
- Understanding your responsibilities when importing, compounding and supplying unapproved peptide products
- Vision loss, NHS
- Wegovy PI, Novo Nordisk
- 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., Rosenstock J et al. · Lancet (London, England) · 2026
- Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study., Buse JB et al. · The lancet. Diabetes & endocrinology · 2026
- CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1., Verma S et al. · Hypertension (Dallas, Tex. : 1979) · 2026
Sources checked: 2026-10-18.
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