Cagrilintide

One molecule, several program names

Cagrilintide is a peptide-based, long-acting amylin analogue. Historical records use AM833 and NNC0174-0833. The current standalone program uses NN9833. Code use changed over time, especially NN9838.^{1476,1477,1478,1479}

Cagrilintide and CagriSema

CagriSema combines cagrilintide with semaglutide. Studies with separate treatment arms help show what each ingredient contributes.^1480,1473

Investigational status

FDA stated on October 1, 2026 that cagrilintide is not a component of an approved drug and cannot be used in compounding under federal law.^{1475,1481,1482}

Standalone phase 2

A dose-finding trial tested weekly standalone cagrilintide for 26 weeks.

706 randomized

Adults without diabetes were randomized across five cagrilintide groups, daily liraglutide or placebo, with lifestyle intervention.¹⁴⁷²

Weight at week 26

Under the trial-product estimand, mean weight change ranged from 6.0% to 10.8% lower across cagrilintide groups versus 3.0% lower with placebo. The highest cagrilintide group was 10.8% lower versus 9.0% with liraglutide.¹⁴⁷²

Why the estimates differ

The treatment-policy analysis accounts for treatment discontinuation and gave estimated weight losses of 5.93% to 10.50% across cagrilintide groups, versus 8.31% with liraglutide and 2.90% with placebo. The trial-product analysis estimates the effect with continued assigned treatment.^1472,1483

Six weeks after treatment

At week 32, observed mean weight remained 5.0% to 9.8% below baseline across cagrilintide groups. Longer follow-up after stopping remains limited.¹⁴⁷²

REDEFINE 1

The phase 3 trial included standalone, combination, semaglutide and placebo arms.

68 weeks

Among 3,417 randomized adults, 302 were assigned to cagrilintide and 705 to placebo.¹⁴⁷³

Two valid weight estimates

At week 68, the official analysis reports 11.8% lower weight with cagrilintide versus 2.3% with placebo under the trial-product estimand. The treatment-policy values were 11.5% and 3.0%.¹⁴⁸⁴

Comparison with semaglutide

At week 68, estimated mean weight loss was 11.8% with cagrilintide and 16.1% with semaglutide using the trial-product analysis. The treatment-policy estimates were 11.5% and 14.9%, respectively.¹⁴⁸⁴

Further analyses

REDEFINE 1 also measured body composition, physical function, blood pressure and waist-related outcomes. These reports examine the same trial cohort.^{1473,1484,1485,1486,1487}

Type 2 diabetes evidence

Two trials provide standalone cagrilintide arms in adults with type 2 diabetes.

A small 32-week comparison

In a 92-person study, mean HbA1c changed by 0.9 percentage points lower with cagrilintide, 1.8 lower with semaglutide and 2.2 lower with CagriSema. Mean weight changed by 8.1%, 5.1% and 15.6% lower. Each arm had 30 or 31 participants.¹⁴⁸⁸

REIMAGINE 2

The standalone comparison included 152 cagrilintide participants and 149 pooled placebo participants. Under the treatment-regimen estimand, HbA1c changed by 1.02 points lower versus 0.62 lower, and weight by 7.4% lower versus 2.0% lower at week 68.¹⁴⁷⁴

How to read the two trials

The earlier study had no placebo group and 30 or 31 people per arm. REIMAGINE 2 was larger overall, with 152 participants in its standalone cagrilintide arm.^1488,1474

Combination evidence

CagriSema findings describe cagrilintide plus semaglutide.

Early combination trial

A 95-person exposed cohort compared ascending cagrilintide groups with matched placebo while everyone received semaglutide. At week 20, estimated weight changes reached 17.1% lower in one combination group versus 9.8% lower with pooled placebo plus semaglutide.¹⁴⁸⁰

Energy intake and appetite

A CagriSema study reported a 65% lower estimated freely chosen food intake than placebo under its test conditions. Another CagriSema study found lower appetite scores and changes in brain responses to food images. Both studies tested the combination.^1489,1490

Comparison with tirzepatide

The cited tirzepatide comparisons tested CagriSema. A completed direct comparison of standalone cagrilintide with tirzepatide was not identified.^1491,1492

Body composition and function

Secondary analyses add useful detail and narrower claims.

Fat and lean tissue

The DXA analysis included 252 participants across all treatment arms. In the cagrilintide subgroup, 62.9% of lost mass was fat and 37.1% was lean soft tissue, which includes muscle, water and other non-fat tissues.¹⁴⁸⁴

Physical function

A post hoc REDEFINE 1 analysis found larger improvements with cagrilintide than placebo on two physical-function questionnaires at week 68. These scores describe participants' reported ability to carry out physical activities.¹⁴⁸⁵

Further muscle research

A registered trial is studying skeletal-muscle insulin sensitivity, composition and function. No results were posted at the registry check.¹⁴⁹³

Safety and antibodies

Gastrointestinal events lead the current trial safety picture.

Gastrointestinal events

In the standalone phase 2 trial, gastrointestinal disorders occurred in 41% to 63% of cagrilintide participants versus 32% with placebo. Nausea occurred in 20% to 47% versus 18%.¹⁴⁷²

Treatment discontinuation

Across all 706 phase 2 participants, 30 stopped treatment because of an adverse event. The source reports this as an overall trial total rather than a cagrilintide-only count.¹⁴⁷²

Anti-drug antibodies

At week 26, anti-cagrilintide antibodies were detected in 46.3% to 73.2% of evaluable participants across dose groups. Neutralizing activity occurred in small numbers. Their clinical importance is unclear.¹⁴⁷²

FDA safety reports

The FDA database returned four report records: two naming cagrilintide alone and two also naming semaglutide. Reported events included gastrointestinal symptoms, allergic-type symptoms and other complaints. These reports cannot establish frequency or causation.^{1494,1495,1496,1497}

Pharmacokinetics

Small studies describe a long half-life and important limits.

Half-life

The phase 1b study with semaglutide reported a cagrilintide terminal half-life of 159 to 195 hours. Single-dose kidney and liver studies reported geometric mean half-lives of 174 to 211 hours.^1480,1498

Kidney impairment

The single-dose kidney study included 33 participants, five with severe impairment. Average exposure in the impairment groups was 1.18 to 1.23 times the normal-function group. Dialysis was excluded.¹⁴⁹⁸

Liver impairment

The single-dose liver study included 32 participants, four with severe impairment. Average exposure in the impairment groups was 0.99 to 1.11 times the normal-function group.¹⁴⁹⁸

Heart rhythm

In healthy participants, the study found no QT-prolongation signal at the reported measurement times: every upper 90% confidence bound for placebo-adjusted QTcF change was below 10 milliseconds. This finding comes from a conference abstract.¹⁴⁹⁹

Ongoing research

The standalone program is moving through phase 3 without posted outcomes yet.

RENEW 1 and RENEW 2

At the saved registry check, the two efficacy and safety studies were active but not recruiting. Estimated enrollments were 300 adults with overweight or obesity and 330 adults with overweight or obesity plus type 2 diabetes.^1500,1501

RENEW 4

The formulation-comparability trial was recruiting with an estimated enrollment of 285. It compares two cagrilintide presentations and had no posted results.¹⁵⁰²

Questions still open

Rare effects after years of exposure, pregnancy safety, completed paediatric outcomes and effects on oral-contraceptive exposure are unresolved.^{1481,1503,1504}

Common questions

01 What is cagrilintide?

Cagrilintide is an investigational, long-acting analogue of the hormone amylin. Human trials have studied it as a weekly subcutaneous injection on its own and together with semaglutide.^{1476,1505,1472,1480}

02 Is cagrilintide a peptide?

Yes. Cagrilintide is a modified amylin peptide with a molecular weight of about 4,409 g/mol. Its design gives it a longer duration of action than natural amylin.^{1476,1505,1506}

03 Do AM833, NNC0174-0833 and NN9833 refer to cagrilintide?

AM833 and NNC0174-0833 are historical cagrilintide names. NN9833 identifies the current standalone program. NN9838 referred to AM833 in 2017 and later became a code for the semaglutide combination.^{1477,1478,1479,1507,1508}

04 Is CagriSema the same as cagrilintide?

CagriSema combines cagrilintide with semaglutide. Cagrilintide is one of its two active ingredients.^{1480,1473,1509}

05 Is cagrilintide approved in the United States?

No. FDA stated on October 1, 2026 that cagrilintide is not a component of an FDA-approved drug. The cited approval and label searches also found no cagrilintide product.^{1475,1481,1482}

06 Can cagrilintide be compounded in the United States?

FDA stated on October 1, 2026 that cagrilintide cannot be used in compounding under federal law. The agency also says it is not a component of an FDA-approved drug.^1482,1510

07 Do the European, United Kingdom or Canadian records mean cagrilintide is approved?

These are development and review records. Europe issued a paediatric-development decision and the United Kingdom a paediatric waiver. Canada listed the cagrilintide-semaglutide combination as under review in its August 31, 2026 table; a separate Canadian record authorizes a clinical trial.^{1511,1512,1513,1514}

08 How much does cagrilintide cost?

There is no approved U.S. product with an established list price. Prices advertised online concern unapproved products.^1475,1481

09 What route has been studied in people?

The cited human studies used subcutaneous injections. Oral, nasal and sublingual cagrilintide remain unsupported by these clinical results.^{1472,1498,1515}

10 What did the standalone phase 2 weight trial find?

In 706 adults without diabetes, a 26-week trial compared five weekly cagrilintide groups with placebo and daily liraglutide. Estimated mean weight loss ranged from 6.0% to 10.8% with cagrilintide, versus 3.0% with placebo, using the trial-product analysis.^{1472,1483,1507}

11 How did cagrilintide compare with liraglutide in that trial?

At week 26, estimated mean weight loss was 10.8% in the 4.5 mg weekly cagrilintide group versus 9.0% with 3.0 mg daily liraglutide. The difference was 1.8 percentage points, p=0.03, using the trial-product analysis.¹⁴⁷²

12 How quickly did effects begin, and what happened after treatment stopped?

The strongest standalone results describe weight at 26 and 68 weeks. In the phase 2 study, six weeks after treatment ended, observed mean weight remained 5.0% to 9.8% below baseline across cagrilintide groups, versus 2.8% with placebo. Longer follow-up after stopping remains limited.¹⁴⁷²

13 What did the cagrilintide arm in REDEFINE 1 show?

REDEFINE 1 randomized 3,417 adults, including 302 assigned to cagrilintide and 705 to placebo. At week 68, estimated mean weight loss was 11.8% versus 2.3% using the trial-product analysis. The treatment-policy analysis gave 11.5% versus 3.0%.^1473,1484

14 Why do REDEFINE 1 summaries show both 11.8% and 11.5%?

The analyses handle treatment discontinuation differently. The 11.8% estimate describes the effect expected with continued assigned treatment. The 11.5% estimate includes the effect of treatment discontinuation under the trial's treatment-policy approach.¹⁴⁸⁴

15 How did standalone cagrilintide compare with semaglutide in REDEFINE 1?

At week 68, estimated mean weight loss was 11.8% with cagrilintide and 16.1% with semaglutide using the trial-product analysis. The treatment-policy estimates were 11.5% and 14.9%, respectively.¹⁴⁸⁴

16 What did the 92-person type 2 diabetes trial find for cagrilintide?

The 32-week study assigned 30 people to cagrilintide, 31 to semaglutide and 31 to CagriSema. Mean HbA1c fell by 0.9, 1.8 and 2.2 percentage points, respectively. Mean weight fell by 8.1%, 5.1% and 15.6%. Each arm was small, and the study had no placebo group.^{1488,1516,1517}

17 What did REIMAGINE 2 add for standalone cagrilintide?

The standalone comparison included 152 people assigned to cagrilintide and 149 to pooled placebo. At week 68, mean HbA1c fell by 1.02 versus 0.62 percentage points, and mean weight fell by 7.4% versus 2.0%, using the treatment-regimen analysis.¹⁴⁷⁴

18 Do CagriSema results prove what cagrilintide does alone?

Standalone results come from participants assigned to cagrilintide alone. The phase 2 monotherapy trial, REDEFINE 1 and REIMAGINE 2 all provide such comparisons. Results from participants receiving CagriSema describe both drugs together.^{1480,1472,1473,1474}

19 Has standalone cagrilintide been compared directly with tirzepatide?

The cited tirzepatide comparisons tested CagriSema. A completed direct comparison of standalone cagrilintide with tirzepatide was not identified.^1491,1492

20 How is cagrilintide thought to work?

Cagrilintide activates amylin receptors and related calcitonin-family receptors. Cell and animal research links these receptors to brain pathways involved in appetite and energy balance. Human trials measure its effects on weight and blood glucose.^{1505,1506,1518,1519,1520}

21 What evidence links cagrilintide to appetite or energy intake?

A CagriSema study reported a 65% lower estimated freely chosen food intake than placebo under its test conditions. Another CagriSema study found lower appetite scores and changes in brain responses to food images. Both studies tested the combination.^1489,1490

22 Does cagrilintide delay gastric emptying?

The standalone answer is uncertain. A CagriSema study found no delay using a paracetamol absorption test under its study conditions. A separate standalone cagrilintide study examined gastric emptying, but its results were not accessible in the cited sources.^{1489,1504,1521}

23 What adverse effects were common in the standalone phase 2 trial?

Gastrointestinal disorders occurred in 41% to 63% of cagrilintide participants versus 32% with placebo. Nausea occurred in 20% to 47% versus 18%. Across all 706 participants, 30 stopped treatment because of an adverse event. That discontinuation total was pooled across all study arms.¹⁴⁷²

24 Can cagrilintide cause tiredness, low mood or hair loss?

Reliable standalone rates for tiredness, sleepiness, low mood and hair loss were not available in the cited results. Gastrointestinal symptoms, especially nausea, were much better documented.^1472,1474

25 Did participants develop antibodies to cagrilintide?

Yes. At week 26, anti-cagrilintide antibodies were detected in 46.3% to 73.2% of evaluable participants across dose groups. Small numbers had antibodies with neutralizing activity in laboratory tests. Many positive follow-up samples also reacted with native amylin.¹⁴⁷²

26 What do the antibody findings mean clinically?

Binding antibodies were common in the phase 2 trial, while neutralizing activity was uncommon. The study left their effect on treatment benefit or safety unclear.^1472,1480

27 How long is cagrilintide's half-life?

The phase 1b study with semaglutide reported a cagrilintide terminal half-life of 159 to 195 hours. Single-dose kidney and liver studies reported geometric mean half-lives of 174 to 211 hours.^1480,1498

28 What is known in kidney or liver impairment?

Single-dose studies included 33 people across kidney-function groups and 32 across liver-function groups. Compared with normal function, average drug exposure was 1.18 to 1.23 times as high in the kidney-impairment groups and 0.99 to 1.11 times as high in the liver-impairment groups. The severe groups had five and four participants; dialysis was excluded.¹⁴⁹⁸

29 What did the QT study show?

In healthy participants, the study found no QT-prolongation signal at the reported measurement times: every upper 90% confidence bound for placebo-adjusted QTcF change was below 10 milliseconds. This finding comes from a conference abstract.^1499,1522

30 What do the FAERS reports show?

The FDA database returned four report records: two naming cagrilintide alone and two also naming semaglutide. Reported events included gastrointestinal symptoms, allergic-type symptoms and other complaints. In these records, frequency and causation are undetermined.^{1494,1495,1496,1497}

31 How complete is the long-term safety evidence?

The standalone evidence includes 26-week and 68-week randomized trials plus small pharmacology studies. Rare events, effects after years of exposure, pregnancy and broad use outside trial criteria remain incompletely characterized.^{1472,1473,1474,1500,1501}

32 Did REDEFINE 1 measure muscle loss?

It measured fat mass and lean soft tissue with DXA scans. In the cagrilintide subgroup, 62.9% of lost mass was fat and 37.1% was lean soft tissue. Lean soft tissue includes muscle, water and other non-fat tissues.¹⁴⁸⁴

33 Did physical function improve in REDEFINE 1?

A post hoc REDEFINE 1 analysis found larger improvements with cagrilintide than placebo on two physical-function questionnaires at week 68. These scores describe participants' reported ability to carry out physical activities.^1485,1473

34 What are the current standalone phase 3 trials?

At the October 2, 2026 UTC registry check, RENEW 1 and RENEW 2 were active but not recruiting, with estimated enrollments of 300 and 330. RENEW 4 was recruiting and planned to compare two presentations of cagrilintide in 285 participants. All three had no posted results.^{1500,1501,1502}

35 Has cagrilintide been studied in children?

Paediatric studies are registered, including protocols involving cagrilintide alone or with semaglutide. Completed paediatric efficacy and safety results were not available in the cited records.^{1511,1512,1503,1523,1524}

36 What is known about cagrilintide in pregnancy?

Human pregnancy safety is unknown. Cagrilintide has no approved U.S. label with pregnancy guidance.¹⁴⁸¹

37 Does cagrilintide change oral contraceptive exposure?

A registered standalone study examined oral-contraceptive exposure and gastric emptying. Its conference listing was accessible, but the results required a login. The effect on contraceptive exposure is unresolved in the accessible sources.^1504,1521

38 What is known about pH, preparation and storage?

There are no approved U.S. preparation or storage instructions for cagrilintide. Published patents describe particular experimental formulations; their pH and stability findings cannot be transferred to other products.^{1481,1525,1526}

39 Can cagrilintide be combined with tirzepatide, retatrutide or other peptides?

Human trials have studied cagrilintide alone and with semaglutide. Benefits and risks of self-selected combinations with tirzepatide, retatrutide or other peptides have not been established in the cited trials.^{1472,1480,1491,1492}

40 Is cagrilintide prohibited in tested sport?

WADA's S0 rule prohibits unapproved pharmacological substances not covered elsewhere, at all times. Cagrilintide's investigational status places it within that rule by interpretation. It is not individually named in the 2026 or 2027 lists.^{1527,1528,1475}

41 What doses and schedules were actually studied in people?

The 26-week phase 2 trial studied weekly subcutaneous cagrilintide doses of 0.3 to 4.5 mg with escalation. REDEFINE 1 used a 2.4 mg weekly standalone arm over 68 weeks. Kidney and liver pharmacokinetic studies used single doses of 0.6 and 0.9 mg, respectively.^{1472,1473,1498}

42 What if appetite suppression fades or weight loss plateaus?

The standalone trials provide average weight changes, but no dependable percentage for subjective appetite suppression or the timing of a plateau. The cited detailed appetite and food-intake experiments tested CagriSema.^{1472,1473,1489,1490}

43 What is known about amyloid and dementia concerns?

The cited human trials did not measure dementia or clinical amyloid outcomes. They therefore leave this question open.^{1505,1506,1472,1473}