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Cagrilintide

Metabolic & Weight LossInvestigational

Last reviewed: May 23, 2026

Also Known As: AM833, Long-acting Amylin Analogue

Peptide Class: Long-Acting Amylin Analogue — Dual Amylin / Calcitonin Receptor Agonist

Regulatory Status: Investigational — CagriSema NDA filed Dec 2025, approval decision expected 2026. WADA-prohibited.

Latest research: REDEFINE 1 Phase 3 results published in NEJM (2025) showed CagriSema produced 20.4% average weight loss over 68 weeks (up to 23% per-protocol). Novo Nordisk filed the FDA NDA in December 2025; approval decision expected in 2026. See CagriSema profile →

What is Cagrilintide?

Cagrilintide is an investigational long-acting amylin analogue developed by Novo Nordisk for chronic weight management. It works by mimicking amylin, a hormone the pancreas releases alongside insulin after meals. Combined with semaglutide as CagriSema, it produced 20.4% average weight loss in the Phase 3 REDEFINE 1 trial (NEJM 2025) — competitive with tirzepatide and approaching retatrutide's efficacy. Novo Nordisk filed an FDA New Drug Application for CagriSema in December 2025. New to peptide research? Start with the basics →

Reported benefits:

  • 20.4% body weight loss with CagriSema combination over 68 weeks (REDEFINE 1, NEJM 2025)
  • Up to 23% weight loss when participants stayed on treatment as planned
  • Reduced appetite and slower stomach emptying via amylin pathway
  • Preserves lean mass better than GLP-class drugs alone in preclinical data
  • Improvements in blood pressure, lipids, and glycemic markers
  • Lower discontinuation rates than tirzepatide in REDEFINE trials

Common research dose: Cagrilintide is dosed at 0.16 mg, 0.30 mg, 0.60 mg, 1.20 mg, or 2.40 mg once weekly via subcutaneous injection. Dose escalation occurs every 4 weeks. CagriSema (the FDA-submitted formulation) uses cagrilintide 2.4 mg + semaglutide 2.4 mg as a fixed-dose combination.

Where to buy: PP maintains a vetted list of peptide vendors with verified discount codes. See Verified Discount Codes → for current options.

How does Cagrilintide work?

Cagrilintide activates amylin and calcitonin receptors in the brain stem (area postrema) — a pathway distinct from GLP-1 — to suppress appetite and slow gastric emptying. The dual amylin/calcitonin receptor agonist activity defines the class. When combined with semaglutide (CagriSema), the non-overlapping mechanisms produce additive effects with potentially better lean-mass preservation than GLP-1 monotherapy.

  1. Amylin Receptor Activation [1]. Cagrilintide mimics amylin, a hormone naturally co-secreted with insulin from pancreatic beta cells. By activating amylin receptors in the brain stem (area postrema), it suppresses appetite and slows gastric emptying.
  2. Calcitonin Receptor Activation [1]. Cagrilintide also activates calcitonin receptors. The dual amylin/calcitonin receptor agonist activity is what defines the class. Acts on different brain pathways than GLP-1 drugs.
  3. Slowed Gastric Emptying [2]. Like GLP-class drugs, cagrilintide significantly slows how quickly food leaves the stomach. The mechanism is independent of GLP-1 pathways, which is why combining the two produces additive effects.
  4. Synergy with GLP-1 Receptor Agonists [3]. In preclinical research, combining amylin analogs with GLP-1 receptor agonists produces greater food intake reduction and body weight loss than either alone, while preserving lean mass.
  5. Lean Mass Preservation [4]. Preclinical data in non-human primates and rodents shows amylin/GLP-1 combinations target fat mass while preserving lean mass — an advantage over GLP-1 monotherapy where 20–40% of weight lost is lean tissue.

What is Cagrilintide used for?

Cagrilintide's evidence base centers on the REDEFINE Phase 3 program for CagriSema (cagrilintide + semaglutide combination) — REDEFINE 1 in obesity and REDEFINE 2 in type 2 diabetes. Cagrilintide monotherapy reached Phase 2 (6–10% weight loss at the highest dose) but most ongoing development is on the combination because of its substantially greater efficacy. Novo Nordisk filed the CagriSema NDA in December 2025.

  1. REDEFINE 1 (CagriSema for Obesity) [3]. Phase 3, 68-week trial in 3,417 adults with obesity. CagriSema produced 20.4% average weight loss (up to 23% per-protocol) vs 3.0% placebo. Published in NEJM 2025.
  2. REDEFINE 2 (CagriSema for Type 2 Diabetes) [5]. Phase 3 trial in adults with T2D. CagriSema produced significant weight loss and A1C reductions, supporting dual-indication potential.
  3. Cagrilintide Monotherapy. Earlier Phase 2 trials of cagrilintide alone produced 6–10% weight loss over 26 weeks at the highest 4.5 mg dose, supporting continued investigation.
  4. Synergy With Semaglutide. The CagriSema combination produces greater weight loss than either component alone, validating the dual amylin/GLP-1 receptor approach.
  5. FDA NDA Submission. Novo Nordisk submitted the CagriSema New Drug Application to the FDA in December 2025; approval decision expected in 2026.

How long does Cagrilintide take to work?

Cagrilintide effects build gradually similar to GLP-class drugs. In CagriSema trials, most weight loss accumulated through the first 60 weeks, with plateaus around weeks 60–68. The dose escalation across 16+ weeks is designed to minimize gastrointestinal side effects. Most users notice reduced appetite within the first 1–2 weeks at the starting dose.

Most users notice reduced appetite within the first 1–2 weeks at the starting dose. In CagriSema trials, weight loss accumulated through the first 60 weeks with plateaus around weeks 60–68. The dose escalation across 16+ weeks is designed to minimize gastrointestinal side effects — escalating too quickly significantly increases the GI burden without improving outcomes.

How is Cagrilintide dosed?

Cagrilintide is administered as a once-weekly subcutaneous injection. Dose escalates every 4 weeks across five steps (0.16 → 0.30 → 0.60 → 1.20 → 2.40 mg) over ~16 weeks to allow tolerance. CagriSema combines cagrilintide 2.4 mg and semaglutide 2.4 mg in a single fixed-dose injection — the FDA-submitted formulation under review (NDA filed December 2025).

Cagrilintide escalation schedule:

  1. Weeks 1–4. 0.16 mg or 0.30 mg once weekly (initiation).
  2. Weeks 5–8. 0.30 mg or 0.60 mg.
  3. Weeks 9–12. 1.20 mg.
  4. Weeks 13–16. 2.40 mg (target maintenance).
  5. CagriSema fixed-dose. 2.4 mg cagrilintide + 2.4 mg semaglutide in a single weekly injection (FDA-submitted formulation).

Holding at the current dose for an additional 4 weeks if side effects are difficult to tolerate is standard practice and does not appear to reduce long-term outcomes — consistent with GLP-class titration practice.

Need to calculate your dose? Convert mg to syringe units and plan reconstitution with the dosage calculator →.

How is Cagrilintide administered?

Cagrilintide is given as a subcutaneous injection — under the skin, not into muscle — once weekly, using a small insulin syringe. The dose escalates every 4 weeks across five steps to allow GI tolerance. For the practical mechanics of insulin syringes, units vs mcg conversion, and subcutaneous technique, see the syringes and injection technique guide.

  1. Route. Subcutaneous injection, once weekly. Common sites are the abdomen (avoiding 2 inches around the navel), upper outer thighs, and back of the upper arms.
  2. Time of day. Any consistent time. Many users inject at the same day and time each week.
  3. With or without food. Either is fine; no fasting requirement.
  4. Site rotation. Use a different site each week to reduce localized irritation.
  5. Missed dose. If less than 5 days late, take as soon as remembered. If 5 or more days late, skip the missed dose and resume on the next scheduled day. Do not double-dose.
  6. Eating pattern. Smaller, more frequent meals reduce nausea. Avoid large fatty meals especially in the 24 hours after injection.
  7. Alcohol. Limit alcohol especially in the first 48 hours after injection — compounds nausea and dehydration.

Timing context. Cagrilintide's long half-life produces steady-state receptor activation independent of meal timing — like GLP-class drugs, no fasting is required. The two timing variables that matter most are weekly consistency (same day each week supports stable plasma levels) and time of day (some users inject in the evening to sleep through peak GI side effects, especially during titration).

AspectRecommendation
FrequencyOnce weekly, same day each week
Best time of dayAny consistent time — evening often preferred to sleep through GI side effects during titration
FoodNo fasting required; inject with or without food
Injection site rotationRotate between abdomen, thigh, upper arm — avoid same site twice within 2 weeks
Half-life~178 hours (~7 days) — supports once-weekly dosing
Steady-stateReached in ~4–5 weeks at each dose level

Dose escalation schedule. Cagrilintide's weekly dose escalates every 4 weeks across 5 tiers. Holding at any step for an extra 4 weeks is standard practice if GI side effects are difficult to tolerate.

WeekTypical doseNotes
1–40.16 mg or 0.30 mgInitiation; assess GI tolerance
5–80.30 mg or 0.60 mgFirst dose increase
9–121.20 mgSecond escalation
13+2.40 mgTarget maintenance dose

Reconstitution math. Choose your bacteriostatic water volume based on dose precision. Lower water volume = higher concentration = smaller syringe draw. Cagrilintide research vials are typically 5 mg. Because doses are small (0.16–2.4 mg weekly), 2 mL reconstitution is the common research convention — it gives clean whole-number units across the dose range. All units below are measured on a U-100 insulin syringe (100 units = 1 mL). The table assumes a 5 mg vial.

BAC waterConcentration0.3 mg dose0.6 mg dose1.2 mg dose2.4 mg dose
1 mL5 mg/mL6 units12 units24 units48 units
2 mL2.5 mg/mL12 units24 units48 units96 units
3 mL1.67 mg/mL18 units36 units72 unitsn/a*

*Draw exceeds standard 100-unit insulin syringe capacity at this reconstitution volume — would require split injections or a lower reconstitution volume.

Units vs mcg. At a 5 mg vial, each unit drawn delivers 50 mcg of Cagrilintide at 1 mL reconstitution, 25 mcg at 2 mL, and 16.7 mcg at 3 mL — the reconstitution volume determines the mcg-per-unit conversion. For a primer on reading insulin syringes and choosing the right barrel size, see our guide on syringes and injection technique.

What does Cagrilintide stack well with?

Cagrilintide's canonical pairing is with semaglutide as CagriSema — the validated fixed-dose combination with 20.4% weight loss in REDEFINE 1. The amylin + GLP-1 dual-mechanism approach produces additive effects with potentially better lean-mass preservation. Avoid stacking with other GLP-class drugs separately — CagriSema already includes semaglutide, so adding tirzepatide or retatrutide on top is redundant.

  1. CagriSema combination. CagriSema (cagrilintide + semaglutide) as a fixed-dose combination is the validated stack. Phase 3 REDEFINE program produced 20.4% average weight loss with this combination.
  2. Cagrilintide monotherapy. Historically tested in Phase 2 alone with 6–10% weight loss; less common in current research given combination efficacy advantage.
  3. Resistance training + 1.2–1.6 g/kg protein. Recommended to preserve lean muscle during rapid weight loss. Amylin/GLP-1 combinations may preserve lean mass better than GLP-1 alone, but training and protein remain important.
  4. Avoid: other GLP-class drugs separately. CagriSema already includes semaglutide; adding tirzepatide or retatrutide on top would be redundant and increase side effects without proportional benefit.

What are the side effects of Cagrilintide?

REDEFINE 1 and REDEFINE 2 reported low single-digit discontinuation rates due to adverse events with CagriSema — lower than some GLP-class drugs. About 72.5% of CagriSema participants reported at least one GI adverse event (most transient and mild to moderate). The amylin/calcitonin pathway has been used clinically (pramlintide is FDA-approved for diabetes), so the mechanism class has an established safety record, but the long-acting cagrilintide molecule is newer.

Common (most users)

  1. Nausea. Most common, dose-dependent. Affects similar percentage as GLP-class drugs.
  2. Vomiting. Especially during titration phase.
  3. Diarrhea. Common throughout therapy.
  4. Constipation. Common with slowed gastric emptying.
  5. Decreased appetite. Expected effect.
  6. Injection site reactions. Mild redness or irritation.

Less common (moderate)

  1. Indigestion and bloating. Common in the first weeks.
  2. Fatigue. Common in first few weeks.
  3. Headache. Often related to reduced food intake or dehydration.

Serious (rare — call a doctor)

  1. Pancreatitis. Class-effect concern with appetite-suppressing peptides.
  2. Gallbladder problems. Risk with rapid weight loss.
  3. Severe allergic reactions. Rare and not commonly reported.
  4. Hypoglycemia. In users with diabetes on insulin/sulfonylureas.

REDEFINE 1 and REDEFINE 2 trials reported low single-digit discontinuation rates due to adverse events with CagriSema, lower than some GLP-class drugs. 72.5% of CagriSema participants reported at least one GI adverse event — most transient and mild to moderate.

Does Cagrilintide interact with other drugs?

Cagrilintide's most relevant interactions parallel GLP-class drugs: insulin/sulfonylureas (hypoglycemia risk in diabetes), oral medications with narrow therapeutic windows (slowed gastric emptying affects absorption), other GLP-class drugs (redundant outside the CagriSema combination), and alcohol (compounds nausea/dehydration).

  1. Insulin and sulfonylureas. Risk of hypoglycemia increases when combined with these in users with diabetes. Dose adjustment typically needed.
  2. Oral medications. Cagrilintide slows stomach emptying, which can affect absorption of oral drugs. Particularly relevant for warfarin, levothyroxine, and certain antibiotics.
  3. GLP-class agonists (when used outside CagriSema). Combining adds side effects without proportional benefit; the CagriSema combination is the studied form.
  4. Birth control pills. Slowed gastric emptying may reduce absorption.
  5. Alcohol. Compounds nausea and dehydration.

How should Cagrilintide be stored?

  1. Lyophilized (powder) form: Store at 2–8°C sealed; freeze at -20°C for long-term storage.
  2. Reconstituted solution: Store at 2–8°C; typically stable for 28–30 days; check vendor's product specifications.
  3. Reconstitute with bacteriostatic water for injection (BAC water). Swirl gently — do not shake.
  4. Do not freeze reconstituted solution.
  5. Protect from light — store in original container.
  6. Discard if cloudy, discolored, or contains particles.

What are the limitations of Cagrilintide research?

Cagrilintide is investigational and not approved by the FDA, EMA, or any major regulatory body. Novo Nordisk submitted the CagriSema NDA in December 2025; approval decision expected in 2026. Long-term safety data extends to 68 weeks from REDEFINE 1; cardiovascular outcomes data is not yet available. The amylin/calcitonin pathway has clinical precedent (pramlintide is FDA-approved for diabetes) but the long-acting cagrilintide molecule is newer. WADA-prohibited.

Cagrilintide is investigational and not approved by the FDA, EMA, or any major regulatory body. Novo Nordisk submitted a New Drug Application for CagriSema (cagrilintide + semaglutide) to the FDA in December 2025. Cagrilintide monotherapy is not currently in active development for approval; the focus is the combination product.

Long-term safety data extends to 68 weeks from REDEFINE 1. Cardiovascular outcomes data is not yet available. The amylin/calcitonin pathway has been used clinically (pramlintide is FDA-approved for diabetes), so the mechanism class has an established safety record, but the long-acting cagrilintide molecule is newer.

Research-grade cagrilintide sold by specialty peptide vendors is intended for laboratory research use only and is not approved for human consumption. The World Anti-Doping Agency prohibits cagrilintide and other peptide hormones in sport.

Where to source Cagrilintide

Cagrilintide is investigational and not available by prescription. CagriSema is under FDA review (NDA filed December 2025). Research-grade product is sold by specialty peptide vendors for laboratory use only. The vendors highlighted below have been vetted for transparent third-party testing, traceable batch documentation, and verified discount codes.

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Cagrilintide FAQ

What is cagrilintide?

Cagrilintide is an investigational long-acting amylin analogue developed by Novo Nordisk for chronic weight management. Amylin is a hormone naturally co-released with insulin from pancreatic beta cells; cagrilintide mimics this hormone with a much longer duration of action. It is most often combined with semaglutide as CagriSema, which is currently under FDA review.

How is cagrilintide different from semaglutide?

Semaglutide activates GLP-1 receptors. Cagrilintide activates amylin and calcitonin receptors. The two work through different brain pathways to suppress appetite and slow gastric emptying. They are typically combined (CagriSema) because the mechanisms are additive — combination trials show greater weight loss than either component alone, with potentially better lean mass preservation.

Does CagriSema beat tirzepatide for weight loss?

Possibly, in adherent users. REDEFINE 1 (NEJM 2025) showed CagriSema produced 20.4% average weight loss over 68 weeks, with up to 23% per-protocol — comparable to tirzepatide's 20.2% in SURMOUNT-5 at the same timepoint. No head-to-head trial has been published. Both fall short of retatrutide's 28.7% in TRIUMPH-4.

Is cagrilintide alone effective for weight loss?

Yes, but modestly compared to combination therapy. Phase 2 cagrilintide monotherapy at 4.5 mg produced 6–10% weight loss over 26 weeks. Most ongoing development is on the CagriSema combination because of its substantially greater efficacy.

What are the side effects?

Most common are gastrointestinal: nausea, vomiting, diarrhea, and constipation. The REDEFINE trials reported low single-digit discontinuation rates due to adverse events, lower than some GLP-class drugs. About 72.5% of CagriSema participants reported at least one GI adverse event — most transient and mild to moderate.

When will the FDA approve CagriSema?

Novo Nordisk filed the New Drug Application in December 2025. Standard FDA review for NDAs typically takes 10–12 months, putting potential approval in late 2026.

Can cagrilintide be combined with tirzepatide?

There is no published clinical data on this combination. Stacking would be experimental and would likely add side effects without proportional benefit. The validated combination is CagriSema (cagrilintide + semaglutide).

Where can I buy cagrilintide?

Cagrilintide is not yet FDA-approved. Research-grade cagrilintide is sold by specialty peptide vendors. PP maintains a list of vetted vendors with verified discount codes — see Verified Discount Codes →.

References

  1. Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398(10317):2160-72. https://pubmed.ncbi.nlm.nih.gov/34798060/
  2. Enebo LB, Berthelsen KK, Kankam M, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg. Lancet. 2021;397(10286):1736-48. https://pubmed.ncbi.nlm.nih.gov/33894838/
  3. Garvey WT, Birkenfeld AL, Dicker D, et al. Once-Weekly CagriSema for the Treatment of Obesity (REDEFINE 1). N Engl J Med. 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2502486
  4. Frias JP, Dahl D, Aronne LJ, et al. Preclinical and clinical evidence for amylin/GLP-1 combination therapy advantages. The Innovation Medicine. 2025. https://www.the-innovation.org/article/doi/10.59717/j.xinn-med.2025.100150
  5. Davies M, Pratley R, et al. Once-Weekly CagriSema in Adults with Obesity and Type 2 Diabetes (REDEFINE 2). N Engl J Med. 2025.

Published Studies

Plain-English summaries of the peer-reviewed studies behind the claims above. Click any title to read the source paper.

The Lancet · 2021Open Access
Once-weekly cagrilintide for weight management in people with overweight and obesity →

Lau DCW, Erichsen L, Francisco AM, et al.

The first Phase 2 trial of cagrilintide as monotherapy for obesity. Over 26 weeks, participants on 2.4 mg cagrilintide lost a mean of 10.8% of body weight vs 3.0% on placebo. The trial established cagrilintide's dose-dependent weight loss profile and informed the design of subsequent combination trials with semaglutide.

The Lancet · 2021Open Access
Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant cagrilintide with semaglutide 2·4 mg →

Enebo LB, Berthelsen KK, Kankam M, et al.

Phase 1b trial examining the combination of cagrilintide and semaglutide. The study confirmed that co-administration was well-tolerated and produced pharmacokinetics consistent with once-weekly dosing for both compounds. This study established the safety foundation for the CagriSema Phase 2 and Phase 3 programs.

The Lancet · 2023Open Access
Efficacy and safety of co-administered cagrilintide 2·4 mg with semaglutide 2·4 mg in type 2 diabetes →

Frias JP, Deenadayalan S, Erichsen L, et al.

Phase 2 trial of CagriSema in patients with type 2 diabetes. The combination produced superior HbA1c reduction and weight loss compared to semaglutide alone, supporting the hypothesis that amylin and GLP-1 pathways act synergistically.

New England Journal of Medicine · 2025Open Access
Once-Weekly CagriSema for the Treatment of Obesity (REDEFINE 1) →

Garvey WT, Birkenfeld AL, Dicker D, et al.

The pivotal Phase 3 trial of CagriSema (cagrilintide + semaglutide combination) for obesity. In 3,417 adults over 68 weeks, CagriSema produced 20.4% average weight loss (up to 23% per-protocol) compared to 3.0% on placebo. This is the trial result that drove Novo Nordisk's December 2025 FDA New Drug Application filing.

Weight LossAmylin AnalogInvestigationalCombination Therapy

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