Direct answer
What you need to know
Evidence strength: ModerateTwo next-generation medicines are close, and neither can be prescribed to you today. CagriSema has been filed with the FDA and is under review. Retatrutide has not been filed at all — Eli Lilly has said it intends to submit in the first quarter of 2027. Between them they have 4 trials on this page, and the difference that matters most is not which lost more weight: 1 of those 4 results has never been peer-reviewed, and it is the one every headline quotes.
Key takeaways
- CagriSema’s results are published in the New England Journal of Medicine and the Lancet. Retatrutide’s famous 28.3% is a company announcement.
- CagriSema has been tested directly against Wegovy. Retatrutide has not been tested against anything approved, for weight.
- Neither is purchasable. What is sold online as retatrutide has been analysed in the literature, and there is a published harm case.
- No approval date exists for either. The FDA does not publish them in advance.
Important limitation: Regulatory status comes from each company’s own announcements, which are the only public statement of intent and are not commitments. Read on 2026-09-19; filings move, and a drug can be rejected or delayed after a successful trial.
Next action: If you are choosing between medicines you can actually be prescribed today, that is the semaglutide and tirzepatide comparison, which is built on a head-to-head trial.
Primary sources: New England Journal of Medicine, REDEFINE 1, Lancet Diabetes & Endocrinology, The Lancet
General education, not medical advice. Nothing on this page can be prescribed to you today.
Where each one actually is
“Coming soon” covers a range from submitted and under review to the company has said it plans to submit, and the two are a year apart here.
| Medicine | What it is | Stage |
|---|---|---|
| CagriSemaNovo Nordisk | cagrilintide 2.4 mg with semaglutide 2.4 mg | Filed with the FDA, under review |
| RetatrutideEli Lilly | retatrutide (LY3437943) | Filing announced, not yet submitted |
CagriSema
A fixed combination of semaglutide, which is already approved as Wegovy, with cagrilintide — an amylin analogue. Amylin is a different hormone from GLP-1, so this is the first weight-management product to combine the two.
Regulatory status. Novo Nordisk announced it had submitted a new drug application to the FDA, with review expected during 2026. The company's announcement is the source for the filing; the FDA does not publish a decision date in advance, and no approval had been announced as of the date this page was read.
REDEFINE 1 — peer-reviewed
Design. Phase 3a, randomised 21:3:3:7, double-blind, placebo- and active-controlled, 3,417 participants, 68 weeks. Compared against: Placebo, with separate semaglutide-alone and cagrilintide-alone arms.
Population. Adults without diabetes, BMI 30+, or 27+ with a weight-related condition
Estimated mean weight change −20.4% with cagrilintide-semaglutide against −3.0% with placebo (difference −17.3 percentage points, 95% CI −18.1 to −16.6, P<0.001). Gastrointestinal adverse events affected 79.6% of the combination group against 39.9% on placebo, described as mainly transient and mild to moderate. Effects were estimated with the treatment-policy estimand, which is the intention-to-treat principle rather than the per-protocol figure a press release usually leads with.
New England Journal of Medicine, REDEFINE 1 · 2025 · NEJM 393:635-647 · NCT05567796
REDEFINE 5 — peer-reviewed
Design. Phase 3a, randomised 1:1, double-blind, active-controlled, 331 participants, 68 weeks. Compared against: Semaglutide 2.4 mg alone — a direct head-to-head.
Population. Adults in Japan and Taiwan with obesity-related complications, with or without type 2 diabetes
Estimated mean weight change −18.4% with cagrilintide-semaglutide against −11.9% with semaglutide alone (treatment difference −6.5 percentage points, 95% CI −8.4 to −4.6, p<0.0001). Adverse events were reported by 87% and 84% respectively, gastrointestinal in 53% and 51% — close to identical. 10% discontinued the combination against 6% on semaglutide.
Lancet Diabetes & Endocrinology · 2026 · Lancet Diabetes Endocrinol 14:450-462
Retatrutide
A single molecule acting at three receptors — GIP, GLP-1 and glucagon. Everything approved today acts at one or two. The glucagon arm is the genuinely new part, and it is why the weight-loss figures are larger and why the side-effect profile is not simply the class profile.
Regulatory status. Eli Lilly has said it intends to submit a biologics licence application in the first quarter of 2027, having told reporters it needed more time to assemble manufacturing and quality-control data. Separately, the company opened a pre-approval expanded-access route in August 2026 for a defined group of patients. Neither is approval, and nothing about either makes the drug purchasable.
TRANSCEND-T2D-1 — peer-reviewed
Design. Phase 3, randomised 1:1:1:1, double-blind, placebo-controlled, 48 sites, 537 participants, 40 weeks. Compared against: Placebo.
Population. Adults with type 2 diabetes inadequately controlled by diet and exercise, HbA1c 7.0–9.5%, BMI 23+
HbA1c fell 1.69% at 4 mg, 1.86% at 9 mg and 1.94% at 12 mg, against 0.81% on placebo, on the treatment-regimen estimand. 91% completed the treatment period on study drug. The authors describe the adverse-event profile as consistent with molecules carrying GLP-1 activity.
The Lancet · 2026 · Lancet 407:2402-2413 · NCT06354660
TRIUMPH-1 — company announcement, not peer-reviewed
Design. Phase 3 — full design and results not yet published, 80 weeks. Compared against: Placebo, per the company's announcement.
Population. Adults with obesity
The company reported mean weight loss of 28.3%, or 70.3 lb, at the highest dose over 80 weeks — the largest figure reported for any medicine in this class. NOT PEER-REVIEWED: this comes from an Eli Lilly announcement and press coverage of it, not from a published trial report, so the full result tables, the estimand used, the discontinuation rate and the adverse-event breakdown are not available to check. Participant numbers are recorded as zero here because the published figure does not state them.
Eli Lilly (investor release), reported by CNBC and BioPharma Dive · 2026-05
Why one of these numbers is not like the others
The largest weight-loss figure ever reported for this class of medicine has never been published in a journal.
Retatrutide’s 28.3% is quoted everywhere, and it may well hold up. But a company announcement and a trial report are different documents. The published report gives the full result tables, states which estimand produced the headline number, and reports how many people stopped and why — all of which is how a reader or a clinician judges whether a figure applies to them. None of that is available for TRIUMPH-1.
The contrast is useful rather than damning. Retatrutide does have peer-reviewed phase 3 results — in type 2 diabetes, in the Lancet, with 537 participants. And CagriSema’s weight figures come from journals that publish the estimand and the dropout rate alongside the headline. So the question is not whether to believe the number. It is whether you would make a decision on a document that cannot be checked.
What is being sold while people wait
A drug with a famous number and no approval creates a market, and that market is now documented in the peer-reviewed literature rather than only in warnings.
- Products sold as retatrutide in Australia were analysed for what they actually contained and how accurately they were labelled. An unapproved molecule has no approved manufacturer, so there is no labelled strength to rely on and no recall route if a batch is wrong. (Drug and Alcohol Review, 2026 · Drug Alcohol Rev 45:e70231 · doi:10.1111/dar.70231)
- A man in his mid-30s with long-standing type 1 diabetes, who had obtained retatrutide online, presented with severe vomiting, diarrhoea, high blood sugar, ketones and acute kidney injury. Retatrutide has no established role in type 1 diabetes and was not prescribed. The report notes that products bought this way are used without medical assessment, without counselling on sick-day management, and with uncertain composition, purity and dosing accuracy. (Cureus, 2026 · Cureus 18:e115260 · doi:10.7759/cureus.115260)
This site already sets out why products sold as research peptides are not a cheaper version of a prescription. Retatrutide is that argument with a live example attached: there is no approved manufacturer, so there is no labelled strength to trust, no pharmacist between the seller and the syringe, and no recall route when a batch is wrong.
Questions people ask
What is the next GLP-1 drug to be approved?
On published filings, CagriSema is closest: Novo Nordisk has submitted a new drug application to the FDA and says review is expected during 2026. Retatrutide is further back — Eli Lilly has said it intends to file in the first quarter of 2027. Neither has been approved, and the FDA does not publish decision dates in advance, so any specific date you see quoted for either is somebody's estimate rather than a published fact.
How much weight did retatrutide cause people to lose?
The figure everyone quotes is 28.3%, or about 70 lb, at the highest dose over 80 weeks — which would be the largest reported for any medicine in this class. It is worth knowing where that number comes from: an Eli Lilly announcement, not a published trial report. The full result tables, the estimand used, the dropout rate and the adverse-event breakdown are not available to check. Retatrutide does have peer-reviewed phase 3 results, but in type 2 diabetes rather than obesity.
Is CagriSema better than Wegovy?
There is a direct trial, which is unusual. REDEFINE 5 randomised 331 adults in Japan and Taiwan to CagriSema or semaglutide alone for 68 weeks and found −18.4% against −11.9%, a difference of 6.5 percentage points. Two caveats travel with that: the population was east Asian and 68% male, so it does not transfer cleanly to a general US population, and side effects were near-identical between the arms — 87% against 84% — so the extra weight loss did not come with an obviously gentler experience.
Can I get retatrutide now?
Not lawfully, and not safely. It is not approved anywhere, which means no pharmacy can dispense it and no prescriber can write for it outside a trial or a company-run access programme. Eli Lilly opened a pre-approval expanded-access route in August 2026 for a defined group of patients; that is a company programme with its own criteria, not a prescription you can request. Anything sold to you online as retatrutide is outside the regulated supply chain entirely.
What is actually in the retatrutide sold online?
Researchers have started measuring it rather than guessing. An analysis published in Drug and Alcohol Review in 2026 examined the composition and labelling accuracy of products sold as retatrutide in Australia. Separately, a case report in Cureus describes a man with type 1 diabetes who obtained retatrutide online and was admitted with vomiting, high blood sugar, ketones and acute kidney injury. An unapproved molecule has no approved manufacturer, so there is no labelled strength to rely on and no recall route when a batch is wrong.
Should I wait for one of these instead of starting an approved drug?
That is a question for a prescriber who knows your history, and the honest input we can give is about timing rather than medicine: neither drug has an approval date, approval is not certain for either, and the gap between approval and a price you can actually pay has historically been months more. Waiting is a decision with its own cost.
When to seek medical care
If you have taken something bought online as a GLP-1 and you are vomiting repeatedly, cannot keep fluids down, or have severe abdominal pain, that is an emergency assessment rather than a wait-and-see. Tell whoever sees you exactly what you took, even if it was not prescribed — the published case on this page turned on that information.This page is general education, not medical advice. Talk to your own healthcare provider about your situation before starting, stopping, or changing any medication.
Sources
Each source below supports specific statements on this page. We cite the strongest available authority and verify against the current version before publishing.
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or ObesityNew England Journal of Medicine, REDEFINE 1Supports: CagriSema: the REDEFINE 1 figures on this page.
- Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5)Lancet Diabetes & EndocrinologySupports: CagriSema: the REDEFINE 5 figures on this page.
- Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1)The LancetSupports: Retatrutide: the TRANSCEND-T2D-1 figures on this page.
- Lilly's triple agonist retatrutide delivered powerful weight lossEli Lilly (investor release), reported by CNBC and BioPharma DiveSupports: Retatrutide: the TRIUMPH-1 figures on this page — a company announcement rather than a published trial report.
- Composition and Labelling Accuracy of Products Sold as Retatrutide in AustraliaDrug and Alcohol ReviewSupports: Products sold as retatrutide in Australia were analysed for what they actually contained and how accurately they were labelled.
- Online-Sourced Retatrutide Complicating Impending Diabetic Ketoacidosis in a Patient With Type 1 Diabetes and Concurrent Shigella GastroenteritisCureusSupports: A man in his mid-30s with long-standing type 1 diabetes, who had obtained retatrutide online, presented with severe vomiting, diarrhoea, high blood sugar, ketones and acute kidney injury.
- Drug approvals, labeling and safety communicationsU.S. Food & Drug AdministrationSupports: That no medicine on this page is approved, and that an unapproved drug has no lawful US supply route to a patient.