GLP-1
Cagrilintide and CagriSema: Amylin Analog Explained - Trial Results, Availability, Risks
Cagrilintide peptide explained: the long-acting amylin analog in Novo Nordisk's CagriSema, what the trials found (20.4% weight loss with semaglutide at 68 weeks), the FDA decision expected in late 2026, side effects, cost, and why online vials are not legal.
Published October 16, 2026 · 14 min read
Key takeaways
- Cagrilintide is Novo Nordisk's once-weekly, long-acting version of amylin, a fullness hormone the pancreas releases with insulin. Alone it produced 10.8% weight loss at the top dose in a 26-week phase 2 trial and 11.8% at 68 weeks in phase 3; combined with semaglutide as CagriSema, 20.4% at 68 weeks counting everyone randomized (22.7% in people who stayed on treatment).
- Neither is approved anywhere. Novo filed CagriSema with FDA on December 18, 2025 and expects a decision in the fourth quarter of 2026; cagrilintide alone is still in phase 3. There is no label, no approved dose and no price.
- Head to head, CagriSema lost to tirzepatide 15 mg in obesity (20.2% versus 23.6% at 84 weeks in REDEFINE 4) and was non-inferior on weight but not on blood sugar in type 2 diabetes.
- Side effects are the GLP-1 class profile: in REDEFINE 1, nausea in 55% versus 12.6% on placebo, plus constipation and vomiting, mainly transient and mild to moderate; 5.9% stopped for side effects versus 3.5%. A 2026 meta-analysis adds a fatigue signal.
- No pharmacy may compound cagrilintide and no clinician may prescribe it outside a trial. 'Cagri' vials sold online are unapproved drugs, and FDA's March 31, 2026 warning letters to research-peptide websites covered cagrilintide.
Cagrilintide at a glance
- Also called
- NNC0174-0833, cagri, cagri peptide, CagriSema (cagrilintide plus semaglutide), long-acting amylin analog
- Class
- Long-acting, lipidated amylin analog that activates amylin and calcitonin receptors; studied alone and as a fixed-dose combination with semaglutide (CagriSema)
- Route
- Once-weekly subcutaneous injection in trials, with the dose stepped up over as long as 16 weeks
- FDA status
- Investigational. Not approved anywhere as of October 10, 2026. Novo Nordisk filed CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) with FDA on December 18, 2025 and expects a decision in the fourth quarter of 2026; cagrilintide alone is in phase 3. Vials sold online are unapproved drugs.
- FDA Category 2 (compounding restricted)
- No
- Available by prescription (US)
- Not as a prescription product
- Best-studied use
- Weight management in adults with obesity or overweight, with and without type 2 diabetes (REDEFINE program); type 2 diabetes (REIMAGINE program); cardiovascular outcomes (REDEFINE 3, ongoing)
- Typical monthly cost (telehealth, 2026)
- None. No product is approved and Novo Nordisk has announced no price
Cagrilintide is the amylin half of CagriSema, the injection Novo Nordisk hopes will follow Wegovy. This hub covers what it is, what the trials found, where approval stands in October 2026, and why the vials sold online are not a shortcut. Two companion pages go deeper: CagriSema vs tirzepatide compares the trial data, and cagrilintide dosage lists every dose the trials used.
What cagrilintide is and how it works
Amylin is a hormone stored with insulin in the pancreas's beta cells and released with it after a meal. It slows stomach emptying, blunts the rise in glucagon after eating, and acts in the brain to reduce food intake (Symlin label). People with diabetes make less of it. The first amylin drug, pramlintide (Symlin, approved in 2005), is a modified copy injected before each major meal by people who use mealtime insulin, and it carries a boxed warning for severe low blood sugar when combined with insulin.
Native amylin is a difficult drug: it clumps into amyloid fibrils, and pramlintide lasts only hours. Novo Nordisk's chemists stabilized the sequence and attached a fatty-acid chain, the same trick that turned GLP-1 into once-weekly semaglutide, producing cagrilintide (Kruse 2021). In people its half-life is 159 to 195 hours, about a week (Enebo 2021). It activates both amylin receptors and the closely related calcitonin receptor, which is why it is sometimes called a dual amylin and calcitonin receptor agonist (Novo Nordisk, September 2026).
Semaglutide works on a different receptor, GLP-1, and the logic of combining them is that both reduce appetite by different routes. In the phase 3 trial that tested each drug alone and together, the combination beat either drug by a wide margin, though the effects did not fully add up: 11.8% weight loss with cagrilintide, 16.1% with semaglutide and 22.7% with both, in people who stayed on treatment (Verma 2026). CagriSema is a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg (the Wegovy maintenance dose), given as one weekly injection (Novo Nordisk, December 2025).
What the evidence actually shows
Cagrilintide on its own
The dose-finding phase 2 trial randomized 706 adults with obesity or overweight and no diabetes to weekly cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg, daily liraglutide 3.0 mg (Saxenda) or placebo for 26 weeks. Weight fell 6.0% to 10.8% across the cagrilintide doses versus 3.0% on placebo, and the 4.5 mg dose beat liraglutide (10.8% versus 9.0%). Gastrointestinal events affected 41% to 63% on cagrilintide versus 32% on placebo, mostly nausea (Lau 2021).
In the phase 3 REDEFINE 1 trial, a cagrilintide-only arm of 302 people produced 11.8% weight loss at 68 weeks in those who stayed on treatment, against 16.1% for semaglutide alone (Verma 2026). Novo is now running a separate phase 3 program for cagrilintide alone, called RENEW, and pitches it as a better-tolerated option, citing a 2.6% discontinuation rate in the REDEFINE 1 cagrilintide arm and about a third of the vomiting seen with GLP-1 drugs (Novo Nordisk, September 2026). Those are company slide figures, not yet broken down in a publication.
CagriSema: the early trials
A phase 1b trial gave 95 adults semaglutide 2.4 mg plus either cagrilintide (0.16 to 4.5 mg) or placebo, escalated in four-week steps over 16 weeks. At 20 weeks, weight loss was 15.7% with cagrilintide 1.2 mg and 17.1% with 2.4 mg, against 9.8% with semaglutide plus placebo (Enebo 2021). A 32-week phase 2 trial in 92 adults with type 2 diabetes compared the combination with each drug alone: HbA1c fell 2.2 points with CagriSema, 1.8 with semaglutide and 0.9 with cagrilintide, and weight fell 15.6%, 5.1% and 8.1%, with no serious low blood sugar (Frias 2023).
Phase 3: REDEFINE 1 and REDEFINE 2
REDEFINE 1 randomized 3,417 adults without diabetes, with a BMI of 30 or more (or 27 or more with a weight-related condition), to CagriSema, semaglutide alone, cagrilintide alone or placebo for 68 weeks. Counting everyone randomized (the treatment-policy estimand, which includes people who stopped), weight fell 20.4% on CagriSema versus 3.0% on placebo; gastrointestinal events affected 79.6% versus 39.9% (Garvey 2025). In people who stayed on treatment, the figures were 22.7% for CagriSema, 16.1% for semaglutide, 11.8% for cagrilintide and 2.3% for placebo, and systolic blood pressure fell 10.9 mm Hg versus 2.8 (Verma 2026). The trial let investigators keep people on lower doses, and at 68 weeks only 57.3% of the CagriSema group were on the full 2.4 mg/2.4 mg dose (see cagrilintide dosage).
REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and a BMI of 27 or more: weight fell 13.7% versus 3.4% at 68 weeks, and 73.5% reached an HbA1c of 6.5% or lower versus 15.9% (Davies 2025). Smaller weight loss in diabetes is the rule for every drug in this class.
These two trials are the basis of the FDA filing (Novo Nordisk, December 2025).
Type 2 diabetes: REIMAGINE
In REIMAGINE 2, 2,713 adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor, were randomized for 68 weeks; CagriSema lowered HbA1c by 1.91 points versus 1.75 with semaglutide 2.4 mg alone, a small but statistically significant edge (Buse 2026). Further REIMAGINE trials tested it in early diabetes and with basal insulin.
Against tirzepatide
Three head-to-head trials have reported, all open-label and all company-reported toplines so far. In obesity, REDEFINE 4 (809 adults, 84 weeks) found 20.2% weight loss with CagriSema versus 23.6% with tirzepatide 15 mg counting everyone, and 23.0% versus 25.5% in people who adhered; it failed its goal of showing CagriSema was not worse (Novo Nordisk, February 2026). In type 2 diabetes, REIMAGINE 4 found CagriSema non-inferior to tirzepatide 15 mg on weight (15.2% versus 15.8%) but not on HbA1c (1.9 versus 2.2 points) (Novo Nordisk, August 2026). A third trial against tirzepatide's lowest maintenance dose favored CagriSema; our CagriSema vs tirzepatide page sets out all three.
| Claim | Grade | What the evidence shows | Sources |
|---|---|---|---|
| CagriSema produces about 20% weight loss in obesity without diabetes | A | REDEFINE 1: 3,417 adults, 68 weeks; 20.4% versus 3.0% counting everyone, 22.7% versus 2.3% in those on treatment. | Garvey 2025; Verma 2026 |
| CagriSema lowers weight and blood sugar in type 2 diabetes | A | REDEFINE 2: 1,206 adults, weight 13.7% versus 3.4%; REIMAGINE 2: 2,713 adults, HbA1c down 1.91 versus 1.75 points with semaglutide alone. | Davies 2025; Buse 2026 |
| Cagrilintide alone causes meaningful weight loss | A | Phase 2: 6.0 to 10.8% at 26 weeks versus 3.0% (706 adults). REDEFINE 1 monotherapy arm: 11.8% at 68 weeks. | Lau 2021; Verma 2026 |
| Cagrilintide adds to semaglutide | A | REDEFINE 1, on treatment: 22.7% combined versus 16.1% semaglutide alone. Phase 1b: 17.1% versus 9.8% at 20 weeks. | Verma 2026; Enebo 2021 |
| CagriSema beats tirzepatide | D | The opposite at full dose: REDEFINE 4, 20.2% versus 23.6% at 84 weeks; non-inferiority not met. It beat only tirzepatide 5 mg. Company-reported, open-label. | Novo Nordisk, February 2026; Novo Nordisk, August 2026 |
| CagriSema lowers blood pressure | B | REDEFINE 1: systolic down 10.9 versus 2.8 mm Hg at 68 weeks. A secondary analysis; likely mostly weight-driven. | Verma 2026 |
| Reduces heart attacks and strokes | C | Unknown. REDEFINE 3, an event-driven outcomes trial in about 7,000 adults with established cardiovascular disease, is ongoing. Semaglutide's own outcome benefit (SELECT) does not transfer automatically to the combination. | Novo Nordisk, February 2026 |
| Better tolerated than GLP-1 drugs | C | Alone, perhaps: Novo reports a 2.6% discontinuation rate in the REDEFINE 1 cagrilintide arm (company slide, basis not published). The combination shows no tolerability advantage: nausea 55% versus 12.6% on placebo, discontinuation 5.9% versus 3.5%, and more fatigue in a 2026 meta-analysis. | Novo Nordisk, September 2026; Novo Nordisk, December 2025; Nong 2026 |
| Online 'cagri' vials are safe and effective | D | No data. No research vial has been tested in a trial or checked by a regulator; FDA's March 2026 warning letters, one covering cagrilintide, treat them as unapproved drugs. | Policy Canary 2026 |
What you are promised versus what is documented
- Documented: about 20% mean weight loss with CagriSema over 68 weeks counting everyone, and about 23% in people who stay on it; 11 to 12% with cagrilintide alone; lower HbA1c and blood pressure.
- Plausible but unproven: fewer heart attacks and strokes (REDEFINE 3 has not reported (Novo Nordisk, February 2026)); better preservation of muscle (Novo is running dedicated muscle, bone and body-composition studies precisely because this is not settled (Novo Nordisk, September 2026)); durable results after stopping (no withdrawal trial has reported, and every GLP-1 withdrawal trial so far shows regain).
- Not supported: that CagriSema beats tirzepatide (the full-dose head-to-head says otherwise), that the combination is gentler than semaglutide alone (no published analysis shows that, and its 55% nausea rate is above the 44% in Wegovy's label trials, per our Zepbound vs Wegovy comparison), and that a vial bought online is the drug the trials used.
Cagrilintide vs CagriSema vs semaglutide vs tirzepatide
| Cagrilintide alone | CagriSema | Semaglutide (Wegovy) | Tirzepatide (Zepbound) | |
|---|---|---|---|---|
| Hormones mimicked | Amylin | Amylin and GLP-1 | GLP-1 | GIP and GLP-1 |
| Pivotal weight loss without diabetes | 11.8% at 68 weeks, on treatment (REDEFINE 1 arm) | 20.4% at 68 weeks counting everyone; 22.7% on treatment | 14.9% at 68 weeks (STEP 1) | 20.9% at 72 weeks at 15 mg (SURMOUNT-1) |
| Head to head | None | Lost to tirzepatide 15 mg (REDEFINE 4) | Lost to tirzepatide (SURMOUNT-5) | Beat both |
| Stopped for side effects, drug versus placebo | 2.6% discontinuation (company figure, basis not published) | 5.9% versus 3.5% | 6.8% versus 3.2% (label) | 4.8 to 6.7% versus 3.4% (label) |
| FDA status, October 2026 | Phase 3 (RENEW) | Under FDA review; decision expected Q4 2026 | Approved | Approved |
| Legitimate monthly cost | None | None announced | $349 cash; $199 for the first two fills | $299 to $449 cash by dose |
Approved-drug figures are from our Zepbound vs Wegovy comparison and the cost guide; cross-trial comparisons are the weakest kind, because the trials differed in population, length and how they counted dropouts.
Side effects and who should not use it
The side-effect profile is the GLP-1 profile. In REDEFINE 1, gastrointestinal events affected 79.6% on CagriSema versus 39.9% on placebo and were mainly transient and mild to moderate (Garvey 2025); nausea affected 55% versus 12.6%, constipation 30.7% versus 11.6% and vomiting 26.1% versus 4.1%. Discontinuation for adverse events was 5.9% versus 3.5% in REDEFINE 1 and 8.4% versus 3% in REDEFINE 2 (Novo Nordisk, December 2025). Across 262 obesity-drug trials, a 2026 BMJ network meta-analysis ranked CagriSema among the drugs with the highest discontinuation for adverse events and found more fatigue: a risk ratio of 3.2, about 92 more people per 1,000 over a year than with lifestyle treatment alone (Nong 2026).
What is not known is as important. There is no long-term safety record beyond the trials; amylin drugs have caused severe low blood sugar when combined with insulin (the pramlintide boxed warning), and how a CagriSema label would handle people on insulin or a sulfonylurea is not yet known; and because CagriSema contains semaglutide, it will almost certainly carry the semaglutide warnings if approved: the rodent thyroid C-cell tumor boxed warning (a contraindication with a personal or family history of medullary thyroid carcinoma or MEN 2), pancreatitis, gallbladder disease, kidney injury from dehydration and aspiration risk under anesthesia. There are no data in pregnancy, breastfeeding, type 1 diabetes or adolescents. The GLP-1 side effects guide covers how the class effects are managed.
Dosage: what was studied, not a protocol
| Trial | Doses (once weekly, under the skin) | Population and duration |
|---|---|---|
| Phase 2, cagrilintide alone | 0.3, 0.6, 1.2, 2.4 or 4.5 mg | 706 adults with obesity, 26 weeks |
| Phase 1b, with semaglutide 2.4 mg | Cagrilintide 0.16 to 4.5 mg, four-week steps over 16 weeks | 95 adults with overweight or obesity, 20 weeks |
| REDEFINE 1 and 2 (CagriSema) | 2.4 mg/2.4 mg after a 16-week escalation; lower doses allowed | 4,623 adults with or without type 2 diabetes, 68 weeks |
| REDEFINE 9 and REIMAGINE (lower doses) | 1.0 mg/1.0 mg and 1.7 mg/1.7 mg | Adults with obesity or type 2 diabetes, 40 to 68 weeks |
In REDEFINE 9, the 1.0 mg/1.0 mg dose produced 21% weight loss at 68 weeks in people who stayed on treatment, not far below the 22.7% the full dose produced in REDEFINE 1, a different trial (Novo Nordisk, September 2026). Every step of the escalations is on our cagrilintide dosage page. We do not publish a reconstitution example: a reconstitution example is for a prescription with a pharmacy label, which is what our peptide calculator is for, and no cagrilintide vial has one.
Availability: what is known and what is not
Known. On December 18, 2025, Novo Nordisk submitted a New Drug Application to FDA for CagriSema for chronic weight management in adults with obesity, or overweight with at least one weight-related condition, based on REDEFINE 1 and 2 (Novo Nordisk, December 2025). Its August 2026 half-year report lists a US decision among the year's expected milestones, and its September 21, 2026 investor presentation puts that decision in the fourth quarter of 2026 (Novo Nordisk, August 2026) (Novo Nordisk, September 2026). Novo has not published an FDA action date. As of October 10, 2026, FDA's drug databases and DailyMed hold no approval or label for cagrilintide.
Known. Cagrilintide alone is in phase 3. The RENEW 1 and RENEW 2 trials, 64 weeks against placebo in obesity without and with type 2 diabetes, are registered to complete in 2027, and Novo's own projection is a 2028 launch (Novo Nordisk, September 2026). A higher-dose CagriSema (cagrilintide 2.4 mg with semaglutide 7.2 mg) entered phase 3 in 2026 (Novo Nordisk, August 2026).
Not known. The price, the final label, the approved doses, and whether FDA approves on schedule. An expected decision date is not an approval.
Why 'cagri' vials online are unapproved drugs
Cagrilintide vials are sold online with research-use disclaimers, often as 'cagri', on its own or premixed with semaglutide. FDA's warning letters of March 31, 2026 to five research-peptide websites covered cagrilintide alongside semaglutide, tirzepatide, retatrutide and mazdutide, and rejected the research label because the websites' dosing guidance, reconstitution help and bundled bacteriostatic water showed the products were meant for people (Policy Canary 2026); our legal tracker lists every letter. For a buyer the problems are practical: nobody has verified what is in the vial or how much, the trials' screening and monitoring do not come with it, and if something goes wrong there is no label, no pharmacist and no one accountable. The same pattern, and the case reports it has already produced, is set out in our retatrutide profile.
Legal status in the United States
- Not approved, so it cannot be prescribed, dispensed or sold for human use outside a clinical trial.
- Not compoundable by any 503A pharmacy or 503B outsourcing facility: cagrilintide is not a component of an FDA-approved drug, has no USP monograph and is not on FDA's 503A bulks list. It does not appear in any of FDA's 503A nomination categories either. A prescription cannot change that.
- Not a controlled substance. Possession is not a crime; the law acts on sellers, as the 2026 warning letters did.
- If FDA approves CagriSema, cagrilintide would become a component of an approved drug. That would not open the door to cheap copies: as with semaglutide and tirzepatide today, compounding a copy of a commercially available drug is limited to a documented individual need.
The legal tracker will be updated when FDA acts.
Cost and how to get treatment now
There is no cost because there is nothing approved to buy. The legitimate paths:
- A clinical trial. ClinicalTrials.gov lists cagrilintide and CagriSema studies by location; a clinician can check eligibility.
- The approved drugs now. Wegovy (semaglutide) costs $349 a month for cash through Novo Nordisk's pharmacy, with $199 for the first two fills for new patients in 2026, and Zepbound (tirzepatide) $299 to $449 by dose through Lilly's program, per our cost guide, and insurance may cover either, depending on the plan. Tirzepatide outperformed CagriSema at full dose head to head, so waiting for CagriSema does not buy more expected weight loss. Our guide to getting peptides prescribed online covers the process, and the complete guide to peptide therapy covers evaluation and monitoring.
Bottom line
Cagrilintide is a genuine new mechanism: a week-long amylin analog that adds roughly five to seven percentage points of weight loss to semaglutide and takes off about 11 to 12% on its own. CagriSema works, with 20% average weight loss counting everyone over 68 weeks, but it did not match tirzepatide at full dose, its nausea rate ran higher than semaglutide's did in separate trials, and its heart-outcome trial has not reported. As of October 10, 2026 it is a drug under FDA review with a decision expected by year end, not a product. The 'cagri peptide' sold online is something else: an unverified powder, illegal to sell for human use, carrying a dose chart copied from trials it was never part of.
Frequently asked questions
+What is cagrilintide?
Cagrilintide is an experimental, long-acting version of amylin, a hormone the pancreas releases together with insulin after meals that signals fullness and slows the stomach. Novo Nordisk added a fatty-acid chain so that one injection lasts a week (half-life 159 to 195 hours), against an injection before every major meal for the older amylin drug pramlintide. It is being developed alone and in CagriSema, a fixed-dose combination with semaglutide, the drug in Wegovy.
+Is CagriSema FDA approved?
No, not as of October 10, 2026. Novo Nordisk submitted a New Drug Application for CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) for chronic weight management on December 18, 2025, and said on September 21, 2026 that it expects an FDA decision in the fourth quarter of 2026. No label exists on DailyMed, no price has been set, and an expected decision is not an approval.
+When will CagriSema be available?
Not before FDA approves it, which Novo expects to be decided in the last quarter of 2026; supply and launch would follow. Cagrilintide on its own is further behind: its phase 3 RENEW trials are expected to finish in 2027 and Novo's own projection is a 2028 launch. Until then the only legitimate access is a clinical trial.
+Is cagrilintide legal to buy?
Owning it is not a crime, but no one may legally sell it to you for human use. Cagrilintide is not approved, so it cannot be prescribed outside a trial, and no 503A pharmacy may compound it because it is not part of an approved drug, has no USP monograph and is not on FDA's bulk-substances list. FDA's March 31, 2026 warning letters to research-peptide websites covered cagrilintide among other products, and rejected 'research use only' labels as a defense.
+How much weight do people lose on cagrilintide alone?
About 10 to 12%. In the 26-week phase 2 trial, weekly doses of 0.3 to 4.5 mg produced 6.0% to 10.8% weight loss against 3.0% on placebo. In the 68-week REDEFINE 1 trial, cagrilintide 2.4 mg alone produced 11.8% in people who stayed on treatment (11.5% counting everyone), against 16.1% for semaglutide 2.4 mg and 22.7% for the combination.
+What are the side effects of cagrilintide and CagriSema?
Mostly gastrointestinal, and mainly transient and mild to moderate. In REDEFINE 1, 79.6% on CagriSema had a gastrointestinal event versus 39.9% on placebo: nausea 55% versus 12.6%, constipation 30.7% versus 11.6% and vomiting 26.1% versus 4.1%. 5.9% stopped because of side effects versus 3.5%. A 2026 network meta-analysis also found more fatigue with CagriSema than with lifestyle treatment alone.
+Is CagriSema better than tirzepatide?
Not in the trials that compared them at full dose. In the open-label REDEFINE 4 trial in obesity, CagriSema produced 20.2% weight loss at 84 weeks against 23.6% for tirzepatide 15 mg (counting everyone) and failed its non-inferiority goal. In type 2 diabetes, REIMAGINE 4 found CagriSema non-inferior on weight but not on HbA1c. Our CagriSema vs tirzepatide page has the full comparison.
+Can a compounding pharmacy make cagrilintide or CagriSema?
No. Federal law lets a 503A pharmacy compound from a bulk substance only if it is a component of an FDA-approved drug, has a USP monograph or is on FDA's 503A bulks list, and cagrilintide meets none of the three. A clinic offering 'compounded cagrilintide' is offering a research vial. If FDA approves CagriSema, compounded copies would still face the limits that now apply to semaglutide and tirzepatide.
+What is the difference between cagrilintide and semaglutide?
They mimic different gut and pancreas hormones. Semaglutide copies GLP-1 and acts on GLP-1 receptors; cagrilintide copies amylin and acts on amylin and calcitonin receptors. Both reduce appetite and slow the stomach, and in trials the combination beat either drug alone: 11.8% weight loss with cagrilintide alone, 16.1% with semaglutide alone and 22.7% with both, in people who stayed on treatment for 68 weeks.
Sources
- StudyGarvey WT et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med 2025;393:635-47. (2025)
- StudyDavies MJ et al. Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2). N Engl J Med 2025;393:648-59. (2025)
- StudyLau DCW 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;398:2160-72. (2021)
- StudyEnebo LB et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet 2021;397:1736-48. (2021)
- StudyFrias JP et al. 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. Lancet 2023;402:720-30. (2023)
- StudyKruse T et al. Development of cagrilintide, a long-acting amylin analogue. J Med Chem 2021;64:11183-94. (2021)
- StudyVerma S et al. CagriSema reduces blood pressure in adults with overweight or obesity: REDEFINE 1. Hypertension 2026;83:e26055. (2026)
- StudyBuse JB et al. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. Lancet Diabetes Endocrinol 2026;14:662-77. (2026)
- ReviewNong K et al. Comparative effects of drugs for adults with overweight or obesity: systematic review and network meta-analysis. BMJ 2026;394:e372161. (2026)
- NewsNovo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. Press release via PR Newswire (BioSpace), December 18, 2025. (2025)
- NewsNovo Nordisk. CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved. Company announcement via BioSpace, February 23, 2026. (2026)
- SourceNovo Nordisk. Financial report for the period 1 January 2026 to 30 June 2026 (company announcement No 48/2026: REIMAGINE 4, REDEFINE 9, 2026 milestones). Form 6-K filed with the SEC, August 4, 2026. (2026)
- SourceNovo Nordisk. Capital Markets Day 2026: obesity presentation (CagriSema US decision expected in Q4 2026; REDEFINE 9; cagrilintide RENEW program). September 21, 2026. (2026)
- NewsPolicy Canary. The research use only loophole just closed: FDA hits seven peptide websites in a single day (warning letters dated March 31, 2026, including a seller of cagrilintide). April 21, 2026. (2026)
- LabelAstraZeneca. SymlinPen (pramlintide acetate) injection: prescribing information, boxed warning and section 12.1 (DailyMed setid 4aea30ff-eb0d-45c1-b114-3127966328ff). (2024)
Written by
The Peptide Doctrine Editorial Team
Our editors write from primary sources — peer-reviewed studies, FDA documents and pharmacy records — and grade every claim by the strength of its evidence. See our editorial policy for how articles are researched, reviewed and updated.
Disclosure. The Peptide Doctrine is an independent editorial project. It currently has no sponsor and runs no advertising: we accept no payment for reviews, rankings or placements, we run no affiliate links, and we do not sell or link to "research-use" peptide vendors. Content is educational and is not medical advice.
Related
Compounds
Retatrutide ('Reta'): Trial Results, Price, Availability - and Why 'Reta Peptide' Online Is Risky
Retatrutide ('reta peptide') in October 2026: the phase 2 result (24.2% at 48 weeks), the phase 3 TRIUMPH results (25% by intention to treat), Lilly's planned 2027 FDA filing, why it cannot be prescribed yet, what the online vials actually are, and how it compares with tirzepatide and semaglutide.
Updated Oct 12, 2026 · 17 min read
GLP-1
Zepbound vs Wegovy: Weight Loss Data, Side Effects, Cost, Compounded Equivalents
Zepbound vs Wegovy in October 2026: the head-to-head trial (20.2% vs 13.7% weight loss), what each label covers (heart, liver, sleep apnea), label side-effect rates, doses and devices, cash prices, Medicare, the pills, and where compounded versions stand.
Updated Oct 12, 2026 · 13 min read
Peptides 101
Are Peptides Legal? FDA Status of Every Major Peptide (2026 Tracker)
Which peptides can be legally prescribed and compounded in the United States as of October 2026, which ones cannot, what changed in 2026 (12 peptides off FDA's Category 2 list, the July advisory votes, the GLP-1 and 'research use only' warning letters), and what it means for you. Updated as FDA acts.
Updated Oct 12, 2026 · 20 min read
Guides
Best Peptides for Weight Loss (2026): Evidence-Ranked
The best peptides for weight loss, ranked by human evidence and US legality in October 2026: tirzepatide and semaglutide first, then liraglutide and tesamorelin, then the compounds sold for fat loss with weak or no human data, with trial numbers, legal status and cost for each.
Updated Oct 12, 2026 · 18 min read