On this page
What it is
Cagrilintide is a lab-made version of amylin, a hormone your pancreas releases alongside insulin after eating. Natural amylin breaks down within minutes, so scientists re-engineered it into a stable, long-acting molecule that can be injected under the skin just once a week.
It was developed by Novo Nordisk (the maker of Ozempic and Wegovy) and has real human clinical-trial data behind it. Its highest-profile use is in CagriSema, a fixed-dose combination pairing cagrilintide with the GLP-1 drug semaglutide. Novo Nordisk has filed CagriSema for FDA approval, but neither CagriSema nor standalone cagrilintide is FDA-approved as of mid-2026.
On the grey market, cagrilintide is sold as a lyophilized (freeze-dried) powder labeled 'for laboratory research use only.' That version is unapproved and unregulated. It is not the pharmaceutical product being reviewed by regulators.
FDA's September 2026 position is explicit: cagrilintide cannot be used in compounding under federal law. Buyers comparing research products should separate that rule from product-quality proof and require exact cagrilintide identity, a COA matched to the current lot, quantitative net content, and sterility and endotoxin evidence when available. Compare current price per verified milligram at /prices/cagrilintide, review vendors at /vendors, and use /methodology for the testing standard.
CagriSema vs tirzepatide 5 mg: September 2026 Phase 3 results
In REIMAGINE 5, adults with type 2 diabetes received once-weekly CagriSema 1.0 mg cagrilintide plus 1.0 mg semaglutide or tirzepatide 5 mg. At week 60, estimated average weight loss was 12.4% with CagriSema and 9.1% with tirzepatide 5 mg. HbA1c fell 1.71 and 1.67 percentage points, respectively, meeting the trial's noninferiority endpoint for HbA1c.
The dose matters. REIMAGINE 5 did not test tirzepatide maintenance doses of 10 mg or 15 mg, so it does not establish a win over those higher doses. Novo Nordisk reported these results as topline data, and full peer-reviewed adverse-event and discontinuation tables are not yet available.
REDEFINE 9 obesity result
In the separate REDEFINE 9 trial, adults with overweight or obesity received CagriSema 1.0 mg/1.0 mg or placebo alongside diet and physical-activity support. At week 68, estimated average weight loss was 21.0% with CagriSema and 2.0% with placebo. This was not a tirzepatide comparison.
Buyer checks for cagrilintide and CagriSema blends
Research-market products do not inherit Novo's trial evidence. A CagriSema-style blend should show component-level identity and quantitative content for both cagrilintide and semaglutide. A single purity number is not enough. Compare cagrilintide price per verified milligram, review current-lot proof through vendor rankings, and apply current deals only after the product and lot pass.
What people research it for
Meaningful weight loss in combination (CagriSema)
Human studiesIn the Phase 3 REDEFINE 1 trial (3,417 adults without diabetes), CagriSema produced a 22.7% mean weight reduction at 68 weeks, and 91.9% of participants lost at least 5% of body weight.
Works as a standalone amylin analog
Human studiesIn a Phase 2 dose-finding trial, cagrilintide monotherapy (2.4 mg) drove roughly 10-11% weight loss at 26 weeks, more than once-daily liraglutide and far above placebo.
Metabolic improvements
Human studiesCagriSema studies reported better blood pressure, waist circumference, lipids, and blood sugar; in REDEFINE 1 a large share of prediabetic participants returned to normal blood sugar.
Convenient once-weekly dosing
Human studiesIts long-acting design allows once-weekly subcutaneous injection rather than daily dosing, which historically improves adherence.
How it works
Amylin signals fullness. Acting mainly through amylin receptors in the brainstem's dorsal vagal complex, it slows how fast the stomach empties, reduces appetite, and helps you feel satisfied with less food. Cagrilintide mimics this satiety signal but lasts far longer than the natural hormone, giving steady once-weekly appetite suppression.
This is why it is paired with semaglutide. Amylin and GLP-1 are separate but complementary appetite pathways, so combining them appears to add up to more appetite reduction than either alone — a 'two brakes' approach to hunger. In plain terms, cagrilintide handles the amylin side of satiety while semaglutide works the GLP-1 side, and together they push food intake down further.
What the research actually shows
Cagrilintide has a genuine clinical-trial record. A Phase 2 monotherapy trial (Lau et al., The Lancet, 2021) established meaningful weight loss and acceptable tolerability, and an early Phase 1b study showed cagrilintide plus semaglutide added to the weight loss seen with semaglutide alone.
The headline data come from Novo Nordisk's Phase 3 REDEFINE program for CagriSema. REDEFINE 1 (adults with obesity, no diabetes) showed 22.7% mean weight loss at 68 weeks, published in the New England Journal of Medicine. REDEFINE 2 (adults with type 2 diabetes) showed a smaller ~13.7% reduction — typical of the blunted weight response seen in diabetes.
Novo Nordisk reported two additional Phase 3 topline readouts on September 21, 2026. In REIMAGINE 5, adults with type 2 diabetes inadequately controlled on metformin, an SGLT2 inhibitor, or both received CagriSema 1.0 mg/1.0 mg or tirzepatide 5 mg. At week 60, estimated average weight loss was 12.4% with CagriSema and 9.1% with tirzepatide 5 mg. HbA1c fell 1.71 and 1.67 percentage points, respectively, and the noninferiority endpoint for HbA1c was met. Tirzepatide maintenance doses of 10 mg and 15 mg were not tested, so this result does not establish superiority over those higher doses.
REDEFINE 9 tested a separate population and comparator. In adults with overweight or obesity, CagriSema 1.0 mg/1.0 mg produced 21.0% estimated average weight loss versus 2.0% with placebo at week 68. Both September results were manufacturer-reported topline data. Novo described overall tolerability as consistent with previous studies, but full peer-reviewed adverse-event and discontinuation tables were not available in the release.
A 2026 systematic review and random-effects meta-analysis by Khan et al. in Naunyn-Schmiedeberg's Archives of Pharmacology pooled seven randomized trials with 8,069 participants. CagriSema was associated with 7.58 kg greater weight loss than semaglutide (95% CI, 4.86 to 10.30 kg greater) and 9.24 kg greater weight loss than cagrilintide (95% CI, 8.02 to 10.46 kg greater), with p<0.00001 for both comparisons. These are pooled mean differences across trials, not one clean head-to-head result from a single uniform population, dose, and follow-up period. The authors assessed risk of bias with RoB 2 and certainty with GRADE, but the PubMed abstract does not report outcome-specific GRADE ratings, so 'GRADE-assessed' should not be read as a blanket high-certainty label.
The meta-analysis strengthens the case that the cagrilintide plus semaglutide combination can outperform either component alone. It does not show that a research-market vial is equivalent to the fixed-dose trial formulation. Buyers should compare current cagrilintide price per mg at /prices/cagrilintide, check vendor documentation at /vendors, and require exact identity, a current lot-matched COA, quantitative net content, and sterility and endotoxin evidence where available.
Honest limits: REDEFINE 1's 22.7% missed Novo Nordisk's own ~25% target and disappointed investors, and much of the strong data reflects the combination, not cagrilintide alone. Long-term safety, durability after stopping, and standalone value are still being studied, and the FDA has not approved either product yet.
Handling & storage
Storage at a glance
Vendor consensus- Lyophilized
- -20°C
- Multiple vendors agree on frozen dry storage, but no public compound-specific expiry study was found.
- Reconstituted
- 2 to 8°C
- Refrigeration is consistent across vendors. Public sources did not provide a defensible shared use-by period.
- Light
- Protect from light and moisture.
- Room temperature
- No compound-specific excursion allowance was found. Limit warm exposure to transit and handling only.
- Reconstitution
- bacteriostatic water
- Use supplier-specific solubility instructions and avoid agitation.
Basis: Vendor consensus. Sources: Palmetto cagrilintide stability discussion
Store sealed cagrilintide powder at -20°C and refrigerate mixed material at 2 to 8°C. Public sources did not support a shared use-by period after mixing, so the card deliberately does not claim one. Protect the vial from light and moisture and avoid agitation.
Cagrilintide is an acylated amylin analogue. Stability data for unmodified amylin should not be substituted for it, and warm exposure should be limited to transit and routine handling.
Safety & cautions
The most common side effects in trials are gastrointestinal — nausea, vomiting, constipation, and diarrhea — the same profile seen with GLP-1 drugs and generally worst when doses are increased. In CagriSema trials these were the leading adverse events, and slow dose escalation is used to reduce them.
Critically, cagrilintide is investigational and not FDA-approved. Grey-market 'research only' powder is unregulated, may vary in purity or dose, is not intended for human use, and carries risks including contamination and inaccurate labeling. This guide is educational and not medical advice; only a licensed clinician can weigh appropriate use of any approved therapy.
Watch Cagrilintide prices
We'll email you when prices drop, a discount code changes, or new lab results come in for Cagrilintide. No spam — only real changes.
Frequently asked questions
Is cagrilintide FDA approved?
No. As of mid-2026 neither standalone cagrilintide nor the CagriSema combination is FDA-approved. Novo Nordisk has submitted CagriSema for FDA review, but it remains investigational.
Can cagrilintide be compounded?
No. FDA's current unapproved GLP-1 page states that cagrilintide and retatrutide cannot be used in compounding under federal law. Research-product comparisons are a separate market question and should be based on exact identity, a current lot-matched COA, measured net content, testing depth, and delivered price per verified milligram.
What is CagriSema?
CagriSema is Novo Nordisk's fixed-dose, once-weekly combination of cagrilintide (an amylin analog) and semaglutide (a GLP-1 drug). It is the first combination pairing these two hormone pathways for weight management and produced 22.7% mean weight loss in the Phase 3 REDEFINE 1 trial.
How is cagrilintide different from semaglutide?
Semaglutide is a GLP-1 receptor agonist; cagrilintide is an amylin analog. They suppress appetite through different but complementary systems, which is why combining them (CagriSema) tends to work better than either alone.
How much weight did people lose?
Cagrilintide alone gave roughly 10-11% weight loss at 26 weeks in Phase 2. CagriSema reached 22.7% at 68 weeks in REDEFINE 1. In the September 2026 topline readouts, CagriSema 1.0 mg/1.0 mg produced 12.4% at week 60 versus 9.1% with tirzepatide 5 mg in REIMAGINE 5, and 21.0% at week 68 versus 2.0% with placebo in REDEFINE 9.
Is the 'research only' powder the same as the drug in trials?
No. Grey-market cagrilintide labeled for laboratory research is unapproved and unregulated, with no guarantee of purity, sterility, or accurate dosing — it is not the pharmaceutical product under FDA review.
Sources
- REDEFINE 1: 22.7% weight loss, published in NEJM (Novo Nordisk / PR Newswire)
- Phase 2 monotherapy dose-finding trial, The Lancet 2021 (PubMed)
- Cagrilintide + semaglutide phase 1b combination study (PubMed)
- Khan et al. 2026 seven-trial CagriSema meta-analysis with GRADE assessment (PubMed)
- Novo Nordisk September 2026 REIMAGINE 5 and REDEFINE 9 topline results
- Novo Nordisk files for FDA approval of CagriSema (PR Newswire)
- FDA concerns with unapproved GLP-1 drugs, including cagrilintide compounding status
Last reviewed September 25, 2026. This guide is educational and research-focused, not medical advice. Cagrilintide products referenced on PeptidePub are sold by third parties as materials for laboratory research use only, not for human or animal consumption.
GO DEEPER
This guide covers one compound. We wrote the book on all 45.
The Peptide Handbook takes everything we know from testing vendors for a living and turns it into five readable books: what each compound actually does, what the evidence really says, and the honest call when the answer is "skip this one." Plus the dosing tables, calendars, and trackers that make it usable.
From the community
Ask a questionNo Cagrilintide discussions yet — ask the first question and our team will answer.