Cagrilintide

A long-acting version of amylin, a hormone the pancreas releases alongside insulin that helps you feel full. It is being developed mainly as a fixed combination with semaglutide under the name CagriSema, and is not approved.

Sold as

Injection under the skin (only within clinical trials).

Legal status in the EU

Not approved in the EU or the US. Novo Nordisk filed an application with the US FDA on 18 December 2025; the press release mentions no application to the European regulator, and no EU assessment page for CagriSema existed at the time of review. Available only within clinical trials.

Cagrilintide is a fat-modified amylin receptor agonist. According to Kruse and colleagues (2021), the problem with natural amylin is that it clumps together easily; attaching a fatty chain gives a stable, long-acting molecule. The idea behind the combination is to stack amylin signalling on top of GLP-1 signalling. The sequence has not been verified against a citable source and is left empty.

Part of the bodyWhat happensHow it is knownKind of evidence

Appetite, in the brain

This is what the drug is for. Amylin is one of the signals the body sends when a meal is finishing, and cagrilintide keeps that signal switched on all week instead of for minutes. What people notice is that they stop eating sooner and stay stopped for longer. Nobody has published a study that put a person in front of a free buffet and measured how much less they ate on cagrilintide, the way this was done for liraglutide — the human evidence for the appetite effect is the weight that came off, not the eating that was watched.

Weight loss measured in 706 adults over 26 weeks in the dose-finding trial and in 302 adults given cagrilintide alone for 68 weeks inside REDEFINE 1. Where in the body it acts is known from animals, not people: in mice bred without two of the helper proteins the amylin receptor is built from, cagrilintide largely stopped working, losing its effect on weight, which is what tells you the effect runs through those receptors.

Measured in people

Source [07]Source [08]Source [09]

Stomach and gut

Feeling sick, being sick, loose stools and constipation, and they show up in the first weeks. On cagrilintide alone the gut trouble is real but noticeably milder than semaglutide and liraglutide cause — those two copy GLP-1, a different gut hormone released after a meal. About half of people on cagrilintide got some gut reaction, against about four in ten on a dummy injection. Put together with semaglutide it becomes the dominant experience of the drug — about four in five. In the trials the sickness and the loose stools peaked while the amount was still being stepped up week by week and then eased off, while the constipation stayed roughly where it was.

Measured in the 3,417 adults of REDEFINE 1 over 68 weeks. Some gut reaction was recorded in 54.0% of the 302 given cagrilintide alone, 79.6% of the 2,106 given cagrilintide together with semaglutide, 73.8% of the 302 given semaglutide alone and 39.9% of the 705 on dummy injections. In the earlier 706-adult dose-finding trial, gut reactions ran from 41% to 63% depending on how much cagrilintide was given, against 32% on dummy injections.

Measured in people

Source [07]Source [08]

Body fat, and where it sits

Weight comes off and the waist comes in. The one thing that has actually been scanned rather than weighed was measured in people given cagrilintide together with semaglutide, and it is worth reading closely: about two thirds of the weight they lost was fat and about a third was lean tissue — muscle and everything else that is not fat. The paper's own authors call that share of lean loss something that warrants further investigation. Nobody has scanned anyone on cagrilintide alone.

Waist measured in all 3,417 adults of REDEFINE 1: down 17.5 cm in people given cagrilintide together with semaglutide against 4.0 cm on dummy injections, a difference of 13.4 cm (95% CI 14.3 to 12.5). The body scan that separates fat from lean tissue was done in only 252 of those 3,417 people, 7.4% of the trial, and only in the combination and dummy groups: fat down 17.0 kg and lean tissue down 8.4 kg on the combination, against 3.4 kg and 2.6 kg on dummy injections.

Measured in people

Source [08]

Blood sugar

Cagrilintide on its own nudges blood sugar down a little; it is not a diabetes drug in the way semaglutide is. In people who already had type 2 diabetes, cagrilintide alone took eight tenths of a percentage point off the long-term blood sugar test — the blood test that shows the average sugar level over the previous two to three months — while semaglutide alone took nearly twice that off and the two together more still. The important safety point is that neither cagrilintide nor semaglutide drives blood sugar dangerously low by itself. It happens when they are added to the older sulfonylurea tablets, which push insulin out whatever the sugar level is doing.

Measured over 68 weeks in the 2,713 adults with type 2 diabetes of REIMAGINE 2, which included a 152-person arm given cagrilintide alone. Those per-arm figures come from Novo Nordisk's own summary of the results presented at a diabetes conference in June 2026; the published journal abstract does not break the cagrilintide-only arm out. In the separate 1,206-person REDEFINE 2 trial, the two severe low-blood-sugar episodes both happened in people also taking a sulfonylurea tablet.

Measured in people

Source [11]Source [12]Source [13]

Heart and blood vessels

Here cagrilintide does the opposite of what its neighbours in this register do, and it is the clearest thing that separates it from them. Semaglutide and liraglutide push the resting heart rate up by a couple of beats a minute. Cagrilintide alone pulled it down by more than three. Blood pressure falls too, though that has only been examined properly in people given the combination, where it fell by about as much as a blood pressure tablet would move it. Nobody knows whether any of this prevents a single heart attack: the trial built to answer that question has finished recruiting 7,101 people with existing heart disease and is not due to report until 2027.

Resting heart rate measured across the 68 weeks of REDEFINE 1: down 3.31 beats a minute on cagrilintide alone, up 0.94 on cagrilintide together with semaglutide, up 1.17 on semaglutide alone, down 0.58 on dummy injections. Blood pressure was measured in the same 3,417 people, and again in a dedicated 2026 analysis; the two give slightly different numbers because they count differently, and both are reported below.

Measured in people

Source [08]Source [14]Source [15]

The skin where the needle goes in

This is the one place where cagrilintide alone caused more trouble than the combination did, which is odd and unexplained. Almost one person in six given cagrilintide on its own had a reaction at the injection site — redness, itching, a lump — against one in thirty-three on dummy injections. Given together with semaglutide the rate was lower, about one in eight. The dose-finding trial found the same thing years earlier: reactions where the needle went in were, alongside gut trouble, the most frequent complaint of the whole trial.

Counted in REDEFINE 1 over 68 weeks: 51 of 302 people on cagrilintide alone (16.9%), 256 of 2,106 on the combination (12.2%), 8 of 302 on semaglutide alone (2.6%) and 21 of 705 on dummy injections (3.0%). In REDEFINE 2, where everyone active got the combination, it was 44 of 904 (4.9%) against none of the 302 on dummy injections.

Measured in people

Source [07]Source [08]Source [13]

Kidneys and liver

Nothing much appears to happen, and that is the useful finding. Two small studies gave a single injection to people whose kidneys or whose liver were working badly and tracked how the drug moved through the body. It behaved the same as in people with normal kidneys and normal livers, which is the sort of result that usually means no separate amount would be needed for those groups. The studies were small, single-dose, and used less than the amount the big trials used.

Measured in 33 people across four levels of kidney function given a single 0.6 mg injection, and 32 people across four levels of liver function given a single 0.9 mg injection. No serious side effects, no withdrawals and no deaths in either study.

One small study

Source [16]

A patch at the base of the brain

The specific place amylin signals are read sits at the bottom of the brain stem, where the brain receives messages coming up from the gut. It is the same region that triggers nausea, which is one reason a drug that acts there makes people feel sick. This has been mapped in animals. In humans, researchers have confirmed the same nerve cells exist in the same place, but nobody has given a person cagrilintide and watched what those cells do.

Mapped across rats, mice and macaque monkeys, with human tissue used only to confirm that the same cell types are present. No functional experiment in this region has been done in a living person.

Only seen in animals

Source [09]Source [10]

REDEFINE 1 (NEJM 2025, 3,417 participants, 68 weeks) gave −20.4% weight with cagrilintide plus semaglutide versus −3.0% for placebo; the study also had arms with semaglutide alone and cagrilintide alone (302 participants each). REDEFINE 2 (NEJM 2025, 1,206 participants, 68 weeks) in type 2 diabetes reported HbA1c of 6.5% or lower in 73.5% versus 15.9% for placebo. REDEFINE 5 (phase 3, 331 participants, Japan and Taiwan) compared the combination against semaglutide alone.

Slow on, and nobody has published what happens coming off. The amount is stepped up over the first four months, not started at full strength: REDEFINE 1 began at a tenth of the target and raised it every four weeks until week 16. That is also when the sickness is worst — nausea, vomiting and loose stools all peaked during those first sixteen weeks and eased afterwards, while constipation did not ease and held roughly level for the remaining year. Weight comes off through the whole first year rather than in a rush; the dose-finding trial was still seeing more weight lost at every step up in amount when it ended at 26 weeks, and cagrilintide alone was at 9.7% by week 26 and 11.5% by week 68. Blood pressure moves early, before the weight loss has finished, and then holds. The gap in this picture is the end of it. The longest anyone has been followed after stopping is 7 weeks in REDEFINE 1 and 6 weeks in the dose-finding trial, and neither published what the weight did in that window. There is no published figure at all for how much weight comes back after cagrilintide is stopped. A 400-person extension study following people after REDEFINE 1 is running and is not due to finish until 2028.

What was measuredWhat happenedIn whomHow it is known

Body weight on cagrilintide alone, over 68 weeks

Down 11.5% against 3.0% on dummy injections. 78.7% lost at least 5% of their weight against 31.5%; 55.1% lost at least 10% against 14.3%; 31.0% lost at least 15% against 5.2%; 15.4% lost at least 20% against 1.9%. Two things to hold onto. This is cagrilintide by itself, not CagriSema. And the paper prints no formal statistical test of this arm against the dummy arm — the comparisons it does print for the cagrilintide arm are described in its own figure legend as done after the fact.

302 adults with obesity, or overweight plus at least one weight-related health problem, and no diabetes; part of the 3,417-person REDEFINE 1 trial across 22 countries, 68 weeks, everyone also given lifestyle advice

Measured in people

Source [08]

Body weight on cagrilintide alone at 26 weeks, and how it compared with daily liraglutide

Across the five amounts tested, weight fell between 6.0% and 10.8% — 6.4 to 11.5 kg — against 3.0%, or 3.3 kg, on dummy injections. More cagrilintide meant more weight lost, all the way to the top amount tested. The largest amount, 4.5 mg, beat daily liraglutide 3.0 mg: 10.8% against 9.0%, a difference of 1.8 percentage points. The 2.4 mg amount that every later trial used gave 9.7% by week 26.

706 adults with obesity, or overweight plus high blood pressure or a blood-fat problem, and no diabetes — roughly 100 in each of five cagrilintide groups, 99 on daily liraglutide 3.0 mg, 101 on dummy injections — at 57 sites in ten countries, 26 weeks

Measured in people

Source [07]Source [08]

Weight and long-term blood sugar on cagrilintide alone in people who already had type 2 diabetes

Weight down 8.4% against 1.5% on dummy injections, and the long-term blood sugar test down 0.80 percentage points against a rise of 0.09. Semaglutide alone did better on both in the same trial — 10.2% and 1.75 points — and the two drugs together better again, 14.2% and 1.91 points. These per-arm numbers come from Novo Nordisk's own summary of the results, presented at a diabetes conference in June 2026; the published journal abstract reports the combination against semaglutide and does not break the cagrilintide-only arm out.

152 adults with type 2 diabetes already taking metformin, the usual first diabetes tablet, some of them also on a tablet that makes the kidneys pass sugar out in urine; inside the 2,713-person REIMAGINE 2 trial across 30 countries, 68 weeks

Measured in people

Source [11]Source [12]

Body weight in people given cagrilintide together with semaglutide, over 68 weeks

Down 20.4% against 3.0% on dummy injections, a difference of 17.3 percentage points (95% CI 18.1 to 16.6). The trial also reports the same result under a second counting rule that treats everyone as though they took the drug as intended, and that gives 22.7% against 2.3% — a difference of 20.4 percentage points, or 21.6 kg. Novo Nordisk's press release led with the second number. Under the first rule, 53.6% lost at least a fifth of their body weight against 1.9%, and 19.3% lost at least 30% against 0.4%. Semaglutide alone in the same trial gave 14.9% and cagrilintide alone 11.5%.

2,108 adults given the combination out of 3,417 randomised, all with obesity or overweight plus a weight-related health problem and no diabetes; mean starting weight 106.9 kg, mean age 47, 67.6% women, 22 countries, 68 weeks

Measured in people

Source [01]Source [08]

Weight and blood sugar in people with type 2 diabetes given cagrilintide together with semaglutide

Weight down 13.7% against 3.4% on dummy injections, a difference of 10.4 percentage points (95% CI 11.2 to 9.5). The long-term blood sugar test fell 1.8 percentage points against 0.4. 73.5% ended up at 6.5% or lower on that test — around the line where diabetes is considered controlled — against 15.9%. Waist down 11.9 cm against 3.6. Everyone in this trial had both drugs; there was no cagrilintide-only arm.

1,206 adults with type 2 diabetes and a BMI of 27 or more, 904 given the combination and 302 dummy injections, mean age 56, mean starting weight 102.2 kg, average 8.5 years since diagnosis, 12 countries, 68 weeks

Measured in people

Source [13]

Blood pressure in people given cagrilintide together with semaglutide

Two published figures for the same trial. The original paper reports the top blood pressure number falling 9.9 mmHg against 3.2 on dummy injections, a difference of 6.7 (95% CI 7.8 to 5.6). A dedicated 2026 analysis of the same trial, counting differently, reports 10.9 against 2.8. Neither is wrong and both are printed here. In that second analysis, 63.0% of the combination group had reached blood pressure targets by week 68 against 32.0%, and 39.6% of those on blood pressure medicine had cut or stopped it against 18.8%. In the 167 people whose high blood pressure had resisted treatment at the start, the difference in reaching target was 42.0% against 29.3%, and the range around that result crossed no difference, so it answered nothing either way.

The 2,108 adults given the combination and the 705 given dummy injections in REDEFINE 1, 68 weeks

Measured in people

Source [08]Source [14]

Getting back into a healthy weight range

Measured as hitting two targets at once — a BMI under 27 and a waist less than half your height — 9.0% of the cagrilintide-alone group managed it against 3.3% on dummy injections. Semaglutide alone: 19.1%. Cagrilintide together with semaglutide: 30.3%. Separately, of the people who started REDEFINE 1 with obesity, 54.0% of those on the combination no longer met the definition of obesity at week 68, against 11.1% on dummy injections.

All 3,417 adults of REDEFINE 1, analysed after the fact for this purpose, 68 weeks

Measured in people

Source [08]Source [17]

How the combination did against tirzepatide, the strongest weight drug on the market

It lost. Over 84 weeks, cagrilintide with semaglutide took off 23.0% of body weight and tirzepatide 15 mg took off 25.5%, counting people as though they took the drug as intended; counting everyone whatever they did, 20.2% against 23.6%. The trial was set up to show the combination was not meaningfully worse than tirzepatide, and it failed to show that. These figures come from Novo Nordisk's announcement of 23 February 2026 and had not been published in a journal at the time of writing.

809 adults with obesity and at least one other health problem, mean starting weight 114.2 kg, everyone knowing which drug they were on, 84 weeks

Measured in people

Source [18]

How much the cagrilintide adds when it is put on top of semaglutide, in Japan and Taiwan

Weight down 18.4% on the combination against 11.9% on semaglutide alone, a difference of 6.5 percentage points (95% CI 8.4 to 4.6). This is the cleanest published answer to the question of what the amylin half of CagriSema contributes, because both groups got semaglutide. Side effects were reported by 87% of the combination group and 84% of the semaglutide group; 10% left the combination against 6%.

331 adults with a BMI of 27 or more plus at least two weight-related health problems, or 35 or more plus one, with or without type 2 diabetes; 68% male, 24% with diabetes; 21 sites in Japan and 1 in Taiwan, 68 weeks

Measured in people

Source [19]

The first time the two drugs were put together in people, over 20 weeks

Adding cagrilintide 2.4 mg to semaglutide 2.4 mg gave 17.1% weight loss against 9.8% for semaglutide with a dummy standing in for the cagrilintide — a difference of 7.4 percentage points (95% CI 11.2 to 3.5). This is the study every later trial was built on, and it is small: 95 people, all of them healthy volunteers aged 18 to 55 at one centre in the United States, none of them with diabetes.

96 healthy adults enrolled and 95 given treatment, aged 18 to 55 with a BMI between 27.0 and 39.9, one centre in the United States, six overlapping groups, 20 weeks

One small study

Source [20]

In REDEFINE 1, stomach and bowel side effects were reported by 79.6% in the combination group versus 39.9% for placebo — nausea, vomiting, diarrhoea, constipation and abdominal pain, which the authors say were usually temporary and mild to moderate. Because the combination contains semaglutide, the risks of the GLP-1 class apply here too. Long-term safety for amylin analogues has not been established.

EffectWhat it feels likeHow often

Death during the trialsSerious

The causes in REDEFINE 2 were cancer of the pancreas, a sudden death from a heart cause, a suicide and one other non-heart cause. All were assessed by an independent committee set up to review deaths without knowing which treatment the person had been on. Six deaths across two trials cannot tell you whether the drug caused any of them; they are here because a record of an unapproved drug that omitted them would be dishonest.

Two of the 2,106 people given cagrilintide together with semaglutide in REDEFINE 1 died — one by suicide, one of a cancer whose origin was never found. Nobody died on cagrilintide alone, on semaglutide alone, or on dummy injections in that trial. In REDEFINE 2, four of 904 on the combination died and none of the 302 on dummy injections.

Source [08]Source [13]

Something serious enough for hospitalSerious

Read the cagrilintide-alone figure carefully: at 8.9% it sits nearer the combination than the dummy injections, which is not what you would guess from the gut-side-effect numbers. What the events actually were differed by group. In the combination group they clustered in the liver, gallbladder and gut; in the cagrilintide-alone group they clustered in infections and in muscle, bone and joint problems. Neither trial reports a rate for individual serious events in the cagrilintide-alone arm.

In REDEFINE 1: 9.8% of people given cagrilintide together with semaglutide, 8.9% of people given cagrilintide alone, 5.0% on semaglutide alone and 6.1% on dummy injections. In REDEFINE 2, on the combination, 10.4% against 12.9% on dummy injections — lower on the drug.

Source [08]Source [13]

Inflammation of the pancreasSerious

Severe pain high in the belly that bores through to the back, often with vomiting. It is a known problem of the semaglutide half of the combination rather than something anyone has pinned on cagrilintide, and no case at all was recorded in either cagrilintide-alone group. With seven cases across more than 3,000 people on the combination, nothing here settles whether the rate is higher than it would have been anyway.

Four of 2,106 people given cagrilintide together with semaglutide in REDEFINE 1 (0.2%), against one of 302 on semaglutide alone (0.3%), none of the 302 on cagrilintide alone and none on dummy injections. In REDEFINE 2, three of 904 on the combination (0.3%) and none of the 302 on dummy injections.

Source [08]Source [13]

Gallbladder problemsSerious

Pain under the right ribs, sometimes fever, sometimes yellowing of the eyes, and sometimes an operation to remove the gallbladder. Losing a lot of weight quickly causes gallstones on its own, so some of this gap is the weight loss rather than the drug — but the dummy group lost weight too and had a quarter the rate.

In REDEFINE 1: 4.1% of people given cagrilintide together with semaglutide, 2.3% on cagrilintide alone, 3.0% on semaglutide alone, 1.0% on dummy injections. In REDEFINE 2: 2.0% on the combination against 0.7% on dummy injections.

Source [08]Source [13]

Blood sugar dropping too lowSerious

Shaking, sweating, confusion and hunger. The detail that matters: both severe episodes were in people also taking a sulfonylurea, an older diabetes tablet that pushes insulin out whether the blood sugar needs it or not. Neither cagrilintide nor semaglutide does that on its own. In REDEFINE 1, where nobody had diabetes, this was not a feature of the trial.

Only really an issue in people who already have type 2 diabetes and are on other diabetes medicines. In REDEFINE 2, among people given cagrilintide together with semaglutide, episodes low enough to matter clinically were reported by 6.0% against 3.3% on dummy injections. Episodes severe enough to need another person's help happened to 2 of 904 (0.2%) and to nobody on dummy injections.

Source [13]

Cancers found during the trialsSerious

Growths of every kind counted together, most of them not cancer, ran at 6.4% on the combination and 4.4% on dummy injections in REDEFINE 1 — and at 1.7% on cagrilintide alone, the lowest of the four groups. The cancers themselves were spread across many different types with no pattern. Sixty-eight weeks is far too short to say anything about cancer risk either way.

In REDEFINE 1, cancers confirmed by the independent review committee: 0.7% on cagrilintide together with semaglutide, 0.7% on cagrilintide alone, 0.7% on semaglutide alone, 0.6% on dummy injections — the same in every group. In REDEFINE 2, 1.5% on the combination against 1.3% on dummy injections.

Source [08]Source [13]

Thoughts of suicide or self-harmSerious

Both trials screened for this deliberately, using a standard interview about suicidal thinking and a nine-question depression questionnaire, at every visit. Neither found a signal in the numbers. A single death does not overturn that, and it is also not nothing.

In REDEFINE 2, screening at every visit found this in 8 of 878 people given cagrilintide together with semaglutide (0.9%) and in 4 of 296 on dummy injections (1.4%) — less common on the drug. In REDEFINE 1, scores on the same screening questionnaires were similar across all four groups and did not shift over the trial. One of the two deaths in REDEFINE 1 was a suicide.

Source [08]Source [13]

Feeling sick, being sick, loose stools and constipation

The defining side effect of this whole class, and cagrilintide by itself is the gentlest version of it here. The sickness and the loose stools were at their worst while the weekly amount was still being stepped up and then eased off; the constipation did not ease and stayed roughly level for the rest of the trial. A pooled analysis of the early trials found vomiting significantly less common on cagrilintide than on semaglutide or liraglutide.

On cagrilintide alone, some gut reaction in 54.0% against 39.9% on dummy injections. On cagrilintide together with semaglutide, 79.6%. On semaglutide alone, 73.8%. In the earlier dose-finding trial, nausea specifically ran from 20% at the smallest amount to 47% at the largest, against 18% on dummy injections.

Source [07]Source [08]Source [21]

Reactions where the needle goes in

Redness, itching or a lump where the injection went. This is the one thing cagrilintide does more of on its own than in the combination, and nobody has explained why. It was already the second most frequent complaint in the 2021 dose-finding trial, alongside gut trouble. It very rarely stopped anyone: only 2.6% of the cagrilintide-alone group left the trial for any side effect at all, which was fewer than left the dummy group.

16.9% on cagrilintide alone against 3.0% on dummy injections — the highest rate of any group in REDEFINE 1. On the combination, 12.2%; on semaglutide alone, 2.6%. In REDEFINE 2, 4.9% on the combination against none at all on dummy injections.

Source [07]Source [08]

Tiredness, dizziness and hair thinning

Hair thinning after fast weight loss is common enough that it is worth naming even without a number, and this is the state of the published evidence: the paper says it happened more often on the combination and does not say how often. Nothing at all is published about how often it happens on cagrilintide alone.

No rate published for any of the three. REDEFINE 1 names them as occurring more often in the group given cagrilintide together with semaglutide than in the dummy group, and prints the numbers only in a supplementary table that is not part of the paper.

Source [08]

Eye problems in people with diabetes

Worth reading twice for the same reason liraglutide's headache figures are. This is a real worry with drugs that drop blood sugar fast in people with long-standing diabetes, it was counted, and the two groups came out level. That is what it looks like when a side effect is mostly not the drug. It was not measured in REDEFINE 1 because nobody there had diabetes.

8.3% on cagrilintide together with semaglutide against 7.9% on dummy injections, in people who already had type 2 diabetes. Almost the same.

Source [13]

Giving up on it

Cagrilintide alone is the only thing in this record that people abandoned less often than they abandoned dummy injections. The combination is a different story, and the pattern is what you would expect: the group with the most gut trouble is the group with the most people walking away. Even so, 88.2% of the combination group were still injecting at week 68, and only 57.4% of them were on the full amount.

In REDEFINE 1, side effects ended treatment for 5.9% of people on cagrilintide together with semaglutide, 2.6% on cagrilintide alone, 3.6% on semaglutide alone and 3.5% on dummy injections. In REDEFINE 2 it was 8.4% on the combination against 3.0%. In the 2021 dose-finding trial, 10% stopped for any reason and 4% because of a side effect.

Source [07]Source [08]Source [13]

These are the amounts the studies below gave their participants, and they are here as facts about those studies. They are not a recommendation, not a starting point and not a range to pick from. What a person should take, if anything, is a question for a doctor who knows them.

The phase 2 dose-finding trial, cagrilintide on its own for weight, 706 adults with obesity and no diabetes — the study that chose the amount everything since has used

0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg once a week, injected under the skin by the participants themselves, with a comparison group on liraglutide 3.0 mg once a day

26 weeks, of which the first 6 were spent stepping the amount up, followed by 6 weeks with no treatment

Source [07]

REDEFINE 1, the cagrilintide-alone arm — the largest and longest study of cagrilintide by itself, 302 adults

2.4 mg once a week, injected under the skin

68 weeks, with the amount stepped up every 4 weeks to the full 2.4 mg by week 16, then held for the rest; 82.5% of this group were on the full amount at week 68

Source [08]

REDEFINE 1, the combination arm — cagrilintide and semaglutide as one injection in a two-chamber pen, 2,108 adults with obesity and no diabetes

2.4 mg of cagrilintide and 2.4 mg of semaglutide once a week, injected under the skin

68 weeks: starting at 0.25 mg of each, increased every 4 weeks to 2.4 mg of each by week 16, then 52 weeks holding there, then 7 weeks of follow-up off treatment. Only 57.4% were on the full amount at week 68 — investigators were allowed to hold people at less

Source [08]

REDEFINE 2, the combination in 904 adults who also had type 2 diabetes

2.4 mg of cagrilintide and 2.4 mg of semaglutide once a week, injected under the skin

68 weeks, stepped up every 4 weeks through 0.5, 1.0 and 1.7 mg of each to the full amount by week 16; 61.9% were on the full amount at the end

Source [13]

REIMAGINE 2, the cagrilintide-alone arm in 152 adults with type 2 diabetes already taking metformin, the usual first diabetes tablet

2.4 mg once a week, injected under the skin

68 weeks

Source [12]

REDEFINE 4, the combination against tirzepatide in 809 adults with obesity

2.4 mg of cagrilintide and 2.4 mg of semaglutide once a week, against tirzepatide 15 mg once a week

84 weeks, with everyone knowing which drug they were on

Source [18]

The first-in-people combination study, 95 healthy volunteers at one centre in the United States

cagrilintide between 0.16 mg and 4.5 mg once a week, given alongside semaglutide 2.4 mg once a week

20 weeks: 16 weeks stepping both drugs up together, 4 weeks at the target amount, then 5 weeks of follow-up

Source [20]

The kidney and liver studies, 65 people in total, at amounts well below what the weight trials used

a single 0.6 mg injection in the kidney study; a single 0.9 mg injection in the liver study

One injection, then tracking of how it cleared the body

Source [16]

What people report

• Whether it prevents a single heart attack or stroke — the 7,101-person trial built to find out is not due to report until September 2027
• How much weight comes back after stopping — no trial has published a figure, and the longest anyone has been watched off the drug is 7 weeks
• Whether it does anything beyond 68 weeks — no study of cagrilintide alone has run longer, and the extension does not finish until October 2028
• How much muscle it takes off — the only body scans in the whole programme were done in 7.4% of one trial and only in people given the combination
• Whether it slows the stomach down in people — the effect is claimed by sellers and is a known property of amylin, but no published trial has measured it for cagrilintide
• Why reactions where the needle goes in are more common on cagrilintide alone, at 16.9%, than on the combination, at 12.2% — nobody has explained it
• Why serious events ran at 8.9% on cagrilintide alone against 6.1% on dummy injections, when the same group had fewer side effects and fewer dropouts than the dummy group
• What the fall in resting heart rate means — cagrilintide lowered it by more than three beats a minute, the opposite of what semaglutide and liraglutide do, and nobody has followed that anywhere
• Whether it is safe in pregnancy — no published trial enrolled a pregnant woman and no reproductive safety data has been published at all
• Whether it does anything in children or teenagers — every published trial required participants to be 18 or over
• Whether it affects bone — cagrilintide also acts on the receptor for calcitonin, a hormone the body uses in bone and calcium handling, and no trial has scanned anyone's bones
• Whether it activates the hormone system that controls blood pressure and kidney function, as one 2026 hypothesis in the Lancet proposes — the four studies suggested to test it have not been done
• What is actually in the vials sold online as cagrilintide — no published laboratory analysis of a gray-market sample exists
• How well any of this holds outside a trial — no health service anywhere prescribes it, so there is no real-world record of who keeps taking it or what they lose

Can I get it? Is it approved?

No, and it is not approved in any country. Novo Nordisk applied to the American regulator in December 2025 for the combination with semaglutide, not for cagrilintide by itself, and said in June 2026 that it expected a decision in the last three months of 2026. Cagrilintide on its own has not been submitted for approval anywhere. Legally, in the United States, selling it is an offence: the regulator has written to sellers telling them so.

Source [05]Source [11]Source [22]

Is CagriSema the same thing as cagrilintide?

No, and this is the single most misread thing about this drug. CagriSema is two drugs in one injection: cagrilintide, and semaglutide — the same semaglutide sold as Wegovy and Ozempic. Almost every figure you will see quoted about cagrilintide, including the 20% and 22.7% weight-loss headlines, belongs to the pair. Cagrilintide on its own, in the same trial and over the same 68 weeks, took off 11.5%. The regulator has documented a seller quoting a CagriSema figure on a page selling cagrilintide alone.

Source [08]Source [22]

How much weight does cagrilintide alone actually take off?

11.5% of body weight over 68 weeks, against 3.0% for people injecting a dummy — so around 8.5 percentage points of it is the drug. Roughly half of people lost at least a tenth of their weight, against about one in seven on dummy injections. At 26 weeks in the earlier trial it was 9.7%, and a larger 4.5 mg amount reached 10.8% and beat daily liraglutide's 9.0%. In people who already had type 2 diabetes it was smaller, 8.4% — the same gap this whole class shows.

Source [07]Source [08]Source [11]

Does it make you as sick as semaglutide?

On its own, clearly less. Some gut reaction was recorded in 54.0% of people on cagrilintide alone, against 73.8% on semaglutide alone and 39.9% on dummy injections, in the same trial. A pooled analysis of the early studies found vomiting significantly less common with cagrilintide than with semaglutide or liraglutide. Fewer people abandoned cagrilintide than abandoned the dummy injections. Combine the two drugs, though, and it becomes the worst of the lot: 79.6%.

Source [08]Source [21]

Did the combination beat Mounjaro?

No. Over 84 weeks against tirzepatide 15 mg — the drug sold as Mounjaro and Zepbound — cagrilintide with semaglutide took off 23.0% of body weight against tirzepatide's 25.5%, and 20.2% against 23.6% once people who stopped or changed treatment are counted in. The trial was designed only to show the combination was not meaningfully worse, and it did not manage even that. This is Novo Nordisk's own announcement of February 2026 and has not been published in a journal.

Source [18]

What happens if I stop?

Nobody has published the answer. That is a straight statement of the record, not a hedge. The dose-finding trial followed people for 6 weeks after treatment ended and REDEFINE 1 for 7 weeks, and neither published what the weight did in that window. There is no figure anywhere for how much comes back after cagrilintide. The extension study set up to follow people from REDEFINE 1 is running and is not due to finish until October 2028. For related drugs, pooled across six trials in 3,236 people, about 60% of the lost weight was back within a year of stopping — but that is those drugs, not this one.

Source [08]Source [23]Source [24]

Does it protect the heart, like semaglutide does?

Unknown, and the trial that will answer it has not reported. Blood pressure falls sharply on the combination, and there is a difference worth knowing about between the two halves: semaglutide pushed resting heart rate up by about one beat a minute while cagrilintide alone pulled it down by more than three. Whether any of that translates into fewer heart attacks is being tested in 7,101 people who already have heart disease, and that trial is not due to report until September 2027.

Source [08]Source [14]Source [15]

Is the powder sold online as cagrilintide the same drug?

Nobody has published a test. The American regulator has confirmed that websites offer cagrilintide for sale labelled 'for laboratory research purposes only' and 'not for human consumption', has said plainly that the label does not change what the product is being sold for, and has told at least one seller that offering it breaks the law. What is in the vial is a separate question from what the label says, and no published analysis of gray-market cagrilintide exists to answer it.

Source [22]

Would it show up in a drug test in sport?

It is banned, and testing for it is being built. Cagrilintide falls under the World Anti-Doping Agency's rule on substances that no health authority anywhere has approved, which applies in and out of competition. A 2026 laboratory study worked out what cagrilintide breaks down into, confirmed those fragments in blood from rats that had been given it, and validated a method for detecting them — the first systematic work of its kind for amylin drugs.

Source [06]Source [25]

1. [01]Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med (2025)
2. [02]Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2). N Engl J Med (2025)
3. [03]Kruse T m.fl. Development of Cagrilintide, a Long-Acting Amylin Analogue. J Med Chem (2021)
4. [04]ClinicalTrials.gov NCT05813925 (REDEFINE 5), fas 3, faktiskt antal deltagare 331, Japan och Taiwan
5. [05]Novo Nordisk – CagriSema new drug application filed with the FDA on 18 December 2025; not approved in the US or the EU (2025)
6. [06]WADA Prohibited List 2026, S0 non-approved substances: substances in clinical development without regulatory approval are prohibited at all times (official publication, Austrian BGBl. III no. 219/2025) (2025)
7. [07]Lau DCW et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trial. Lancet (2021)
8. [08]Garvey WT et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1), Figure 1 and Table 2, cagrilintide-alone arm. N Engl J Med (2025)
9. [09]Carvas AO et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 (mice). EBioMedicine (2025)
10. [10]Ludwig MQ et al. A cross-species atlas of the dorsal vagal complex reveals neural mediators of the effects of cagrilintide on energy balance. Nat Metab (2026)
11. [11]Novo Nordisk — CagriSema results across the REIMAGINE programme presented at ADA 2026, per-arm figures including cagrilintide 2.4 mg alone (company press release, not a peer-reviewed publication) (2026)
12. [12]Buse JB et al. Cagrilintide-semaglutide versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2). Lancet Diabetes Endocrinol (2026)
13. [13]Davies MJ et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2), Table 3 and hypoglycaemia. N Engl J Med (2025)
14. [14]Verma S et al. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Hypertension (2026)
15. [15]ClinicalTrials.gov NCT05669755 (REDEFINE 3), cardiovascular outcomes, 7,101 participants enrolled, primary completion estimated September 2027
16. [16]Nielsen MJF et al. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet (2026)
17. [17]Busetto L et al. Efficacy of CagriSema for Reaching Anthropometric Treatment Targets and Cardiometabolic Outcomes: A Secondary, Post hoc Analysis of REDEFINE 1. Diabetes Obes Metab (2026)
18. [18]Novo Nordisk — REDEFINE 4 headline results, 23 February 2026: CagriSema did not meet the primary endpoint of non-inferiority against tirzepatide 15 mg (company announcement, not a peer-reviewed publication) (2026)
19. [19]Yamauchi T et al. 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 Endocrinol (2026)
20. [20]Enebo 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)
21. [21]Dutta D et al. Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide as Anti-Obesity Medications: A Systematic Review and Meta-Analysis (3 randomised trials, 430 people). Indian J Endocrinol Metab (2024)
22. [22]US Food and Drug Administration warning letter to Prime Sciences, 31 March 2026: cagrilintide offered for sale is an unapproved new drug under section 505(a) (2026)
23. [23]ClinicalTrials.gov NCT06780449, long-term extension of CagriSema in obesity, 400 participants, estimated completion October 2028
24. [24]Trajectory of weight regain after cessation of GLP-1 receptor agonists: a systematic review and nonlinear meta-regression (6 trials, 3,236 participants; does not include cagrilintide). eClinicalMedicine (2026)
25. [25]Alhalabi H et al. In vitro metabolic profiling of weight-loss-inducing amylin receptor agonists in the context of preventive doping research. J Pharm Biomed Anal (2026)