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Long-acting amylin analog

Cagrilintide

Cagrilintide is an investigational long-acting amylin analog from Novo Nordisk, studied alone and with semaglutide, as CagriSema, for weight management.

Medical review in progressLast reviewed

US regulatory status

Investigational, not approved

Neither cagrilintide nor CagriSema (cagrilintide with semaglutide) is FDA-approved. Novo Nordisk submitted CagriSema for weight management in December 2025 and expected a decision by late 2026; no approval had been announced as of October 16, 2026. The FDA says cagrilintide cannot be used in compounding, and it has warned a website selling it as a “research” peptide.

As of

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On this page
  1. US regulatory status
  2. At a glance
  3. What the research shows
  4. Side effects and safety
  5. Vial math
  6. Questions people ask
  7. Sources
  8. Related compounds

At a glance

Also known as
AM833
Supplied as
Freeze-dried powder, mixed before use
Research
Limited human evidence
US status
US status: Investigationalchecked

What the research shows

Evidence grade

Limited human evidence

Some studies in people, but they are small, short, early-phase or uncontrolled.

Most of the evidence is for CagriSema. In REDEFINE 1 (3,417 adults with overweight or obesity and no diabetes, 68 weeks), average weight change was −20.4% on CagriSema, compared with −3.0% on placebo. In REDEFINE 2 (1,206 adults with obesity and type 2 diabetes, 68 weeks), it was −13.7%, compared with −3.4%, and 73.5% reached an HbA1c of 6.5% or lower, compared with 15.9% on placebo. In REIMAGINE 3 (274 adults with type 2 diabetes using basal insulin, 40 weeks), HbA1c fell by 2.10 to 2.33 percentage points in people who stayed on treatment, compared with 0.66 on placebo, with body-weight reductions of 10% to 12%. In REDEFINE 4, an open-label 84-week trial in 809 adults with obesity, CagriSema did not meet its main goal of showing weight loss at least as large as tirzepatide’s: Novo Nordisk reported 20.2% with CagriSema and 23.6% with tirzepatide, figures not yet peer reviewed. Cagrilintide alone was tested in a 26-week phase 2 trial: weight loss was 6.0% to 10.8% across the doses tested, compared with 3.0% on placebo; the highest dose produced 10.8%, compared with 9.0% on liraglutide in the same trial. Novo Nordisk funded these trials.

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How we grade evidence

  1. Strong human evidence

    Consistent results from large randomized controlled trials in people.

  2. Limited human evidence · this page

    Some studies in people, but they are small, short, early-phase or uncontrolled.

  3. Mixed evidence

    Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.

  4. Animal or lab studies only

    Studied in cells or animals, not properly in people. Animal results may not apply to humans.

The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.

Side effects and safety

There is no FDA label for cagrilintide or CagriSema, so there is no official list of warnings. Digestive side effects were the most common. In REDEFINE 1, 79.6% of people on CagriSema had digestive adverse events, compared with 39.9% on placebo, mainly short-lived and mild to moderate; in REDEFINE 2 the figures were 72.5% and 34.4%. In the phase 2 trial of cagrilintide alone, digestive events affected 41% to 63% of people across the doses tested (32% on placebo) and nausea 20% to 47% (18% on placebo), and injection-site reactions were among the most frequent. No severe low blood sugar was reported in REIMAGINE 3, where everyone also used insulin. CagriSema contains semaglutide, whose approved labels carry a boxed warning about thyroid C-cell tumors in rodents. Cagrilintide sold online is an unapproved drug whose identity, purity and sterility are not verified.

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Vial math

Pre-filled calculators turn your vial, water and prescribed dose into syringe units.

Pre-filled for your vial size

These pages do the arithmetic for a vial you already have. They don’t suggest a dose.

This is arithmetic, not medical advice. Confirm with your prescriber or pharmacist.

Questions people ask

What is cagrilintide?

A long-acting analog of amylin, a hormone made by the pancreas that brings on a feeling of fullness. Novo Nordisk developed it as a once-weekly injection for weight management: its half-life is 159 to 195 hours, about a week. It is being studied alone and combined with semaglutide, the active ingredient in Wegovy and Ozempic, in a product called CagriSema.

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Is CagriSema FDA-approved?

Not yet. Novo Nordisk submitted CagriSema to the FDA for weight management in December 2025, based on REDEFINE 1 and REDEFINE 2, and said it expected a decision by late 2026. No approval had been announced as of October 16, 2026, and we found no published decision date. Cagrilintide alone is not approved either, and the FDA says it cannot be used in compounding.

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How much weight did people lose on CagriSema in trials?

In REDEFINE 1, adults with overweight or obesity but no diabetes lost an average of 20.4% of their body weight over 68 weeks, compared with 3.0% on placebo, a difference of 17.3 percentage points. In REDEFINE 2, adults who also had type 2 diabetes lost an average of 13.7%, compared with 3.4% on placebo. Both trials were funded by Novo Nordisk.

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How does CagriSema compare with tirzepatide?

In REDEFINE 4, an open-label trial in 809 adults with obesity over 84 weeks, CagriSema did not meet its main goal of showing weight loss at least as large as tirzepatide’s. Novo Nordisk reported average weight loss of 20.2% with CagriSema and 23.6% with tirzepatide, counting everyone assigned to treatment; its headline 23% counts only people who stayed on treatment (23.0% vs 25.5%). These are company figures from February 2026, not yet peer reviewed. Tirzepatide is FDA-approved for weight management as Zepbound; CagriSema is not approved.

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What are the side effects of cagrilintide?

Mostly digestive, with nausea the most common detail reported, plus injection-site reactions. In the phase 2 trial of cagrilintide alone, nausea affected 20% to 47% of people across the doses tested, compared with 18% on placebo, and injection-site reactions were common. Combined with semaglutide in REDEFINE 1, 79.6% had digestive side effects, compared with 39.9% on placebo; most were mild to moderate and short-lived.

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Can retatrutide and cagrilintide be used together?

They have not been studied together: we found no trial combining them, so the safety of using both is unknown. Neither is FDA-approved, and the FDA says neither can be used in compounding. Retatrutide is being developed by Eli Lilly and cagrilintide by Novo Nordisk, in separate trial programs.

Source

Sources

  1. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight managementNovo Nordisk, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  2. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity; the primary endpoint was not achievedNovo Nordisk, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  3. Novel Drug Approvals for 2026U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  4. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  5. A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1), NCT05567796ClinicalTrials.gov, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  6. Warning letter: Summit Research Peptides (MARCS-CMS 695607)U.S. Food and Drug Administration, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  7. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or ObesityN Engl J Med, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  8. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 DiabetesN Engl J Med, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  9. 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 studyLancet, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  10. 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 trialLancet, 2021 · Accessed Oct 16, 2026 (opens in a new tab)
  11. WEGOVY (semaglutide) injection and tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  12. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight managementLancet, 2021 · Accessed Oct 16, 2026 (opens in a new tab)
  13. ZEPBOUND (tirzepatide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)

Related compounds

Guides

Medical review in progressLast reviewed

Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.

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