Cagrilintide is an investigational long-acting analog of amylin, the pancreatic hormone that signals fullness after a meal, developed by Novo Nordisk under the original designation AM833. Its clinical interest sits in weight management, studied both on its own and, more prominently, in the fixed-combination product CagriSema that pairs it with the GLP-1 receptor agonist semaglutide. As of this writing it carries no FDA or other major-regulator approval for any indication and remains an experimental compound moving through late-stage trials.
Cagrilintide is an investigational once-weekly amylin analog developed by Novo Nordisk that is not approved by the FDA or other major regulators for any indication as of this writing.
Cagrilintide is a synthetic analog of amylin, the 37-amino-acid hormone that pancreatic beta cells release alongside insulin when blood glucose rises after eating. Native amylin ends a meal by slowing gastric emptying, signaling fullness through hindbrain receptors, and holding down glucagon, but it aggregates readily and clears within minutes, which makes it impractical as a drug. Cagrilintide was re-engineered to keep those actions while lasting about a week, so a single weekly injection can hold appetite and gastric emptying in check across the whole dosing interval.
Cagrilintide is a dual amylin and calcitonin receptor agonist engineered with albumin binding to extend its half-life to roughly one week, reproducing amylin's appetite-suppressing effects across a once-weekly dose.
Cagrilintide's development program centers on chronic weight management, the same broad indication that carried GLP-1 drugs like semaglutide into widespread use. Because the compound is investigational, the people actually receiving it are trial participants who meet defined enrollment criteria and are monitored under protocol, not the general public. The realistic population today is adults with obesity or overweight-plus-complications enrolled in a supervised trial.
Cagrilintide is being studied for chronic weight management in adults with obesity (body mass index of 30 or higher) or overweight (body mass index of 27 or higher) with a weight-related complication, with an extended arm in adults who have type 2 diabetes.
The clinical record shows cagrilintide produces clinically meaningful weight loss, larger in combination with semaglutide than as a single agent. Single-agent trials landed in the high single digits to about ten percent of body weight over roughly six months, while the CagriSema phase 3 program reported roughly fifteen to twenty-two percent depending on the population and the completion analysis. Those combination figures drew scrutiny because a sizable share of participants never reached the maximum dose.
In phase 3 trials CagriSema produced average weight loss of roughly fifteen to twenty-two percent of body weight depending on the population and analysis, larger than single-agent cagrilintide's high-single-digit to roughly ten percent reductions.
CagriSema is a fixed-dose combination that co-formulates cagrilintide, the long-acting amylin analog, with semaglutide, the GLP-1 receptor agonist already marketed for diabetes and obesity, into a single once-weekly subcutaneous injection. The logic is mechanistic complementarity: GLP-1 agonists work through the GLP-1 receptor, amylin analogs through the separate amylin and calcitonin system, so the pairing recruits two distinct satiety pathways instead of pushing harder on one. In practice that produced greater average weight loss than semaglutide alone, though the flagship obesity trial landed somewhat below the highest pre-trial expectations.
| Criteria | Cagrilintide alone | Semaglutide alone | CagriSema |
|---|---|---|---|
| Receptor pathway | Amylin/calcitonin | GLP-1 | Both pathways combined |
| Typical weight loss | High single digits to ~10% | ~15% in obesity trials | Mid-teens to low-twenties percent |
| Dosing | Once-weekly subcutaneous | Once-weekly subcutaneous | Single once-weekly co-formulated pen |
| Dominant side effects | Gastrointestinal | Gastrointestinal | Gastrointestinal, not multiplied in lockstep |
CagriSema co-formulates cagrilintide and semaglutide into one weekly injection that recruits both the amylin and GLP-1 satiety pathways, producing mid-teens to low-twenties percent average weight loss, greater than semaglutide monotherapy.
Cagrilintide is delivered as a subcutaneous injection, typically into the abdomen, thigh, or upper arm, once weekly, matching the long half-life the molecule was engineered for. Dosing is not started at full strength; the dose is escalated in steps over several weeks so the gastrointestinal effects that dominate the early weeks stay tolerable. All of these specifics come from investigational protocols, since there is no approved cagrilintide label defining an official dose for general use.
Investigational protocols describe cagrilintide as a once-weekly subcutaneous injection escalated in steps over several weeks, with no approved label defining an official dose for general use.
The side-effect profile is dominated by gastrointestinal effects, the same category that limits GLP-1 drugs, since both slow gastric emptying and act on appetite centers. Most reported problems are most intense during the early dose-escalation weeks before easing as the body adapts, and most are described as mild to moderate. Because the compound is still investigational, its rare and long-term risks are not yet fully characterized.
Cagrilintide's most common adverse effects are gastrointestinal, including nausea, vomiting, diarrhea, and constipation concentrated in the early dose-escalation weeks, while its rare and long-term risks remain uncharacterized because the compound is still investigational.
The clearest way to place cagrilintide next to semaglutide and tirzepatide is by mechanism. Semaglutide is a GLP-1 receptor agonist, tirzepatide is a dual GIP and GLP-1 agonist, and cagrilintide is neither, acting on the amylin and calcitonin system, so it is positioned as a complement that stacks onto GLP-1 therapy rather than a head-to-head incretin rival. On its own its weight-loss magnitude generally sits below the strongest single agents like high-dose tirzepatide, which is why the combination approach is emphasized.
| Criteria | Semaglutide | Tirzepatide | Cagrilintide |
|---|---|---|---|
| Receptor mechanism | GLP-1 agonist | Dual GIP/GLP-1 agonist | Amylin/calcitonin agonist |
| Role in weight management | Established monotherapy | Peak-efficacy monotherapy | Complement stacked onto GLP-1 |
| Single-agent weight loss | ~15% in obesity trials | Among the largest recorded | Below strongest single agents |
| Side-effect character | Gastrointestinal | Gastrointestinal | Gastrointestinal |
Cagrilintide acts on the amylin and calcitonin receptor system rather than the incretin receptors targeted by semaglutide (GLP-1) and tirzepatide (GIP and GLP-1), positioning it as a complement stacked onto GLP-1 therapy rather than a competing single agent.
As of this writing, cagrilintide is not approved by the U.S. Food and Drug Administration or by other major regulatory agencies for any use, on its own or as the combination product CagriSema. It is an investigational drug, existing legally only within the framework of authorized clinical trials and regulatory submissions, with no approved label and no official dose for general prescribing. That status is what separates the trial-grade compound from peptides sold through gray-market channels as research chemicals or compounded products.
Cagrilintide is an investigational drug with no FDA or other major-regulator approval for any use, meaning it has no approved label, no official general-use dose, and no legal prescribing pathway outside an authorized clinical trial.
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