What is Cagrilintide?

Cagrilintide is a long-acting synthetic analog of human amylin, developed by Novo Nordisk. It acts on amylin receptors (AMY1/AMY2/AMY3) to slow gastric emptying, suppress post-prandial glucagon, and increase satiety via central pathways. It is currently in Phase 2-3 clinical investigation.

What is CagriSema and why is it being studied?

CagriSema is the combination of Cagrilintide with semaglutide (a GLP-1 agonist). By acting on two distinct receptors — AMY receptors and GLP-1R — the combination produces a synergistic effect that surpasses either component alone. Phase 2 (REDEFINE) trials show weight reductions of ~15-20%, significantly greater than with semaglutide alone (~8-9%).

Is Cagrilintide available in Colombia?

No. Cagrilintide has no INVIMA approval and no regulatory approval from any agency for clinical use in humans. It is in advanced clinical research (Phase 3, REDEFINE 1/2 and SCALE NEXT trials). Vital Boost Colombia provides up-to-date educational information on the research status of this molecule.

What are the main contraindications for Cagrilintide?

According to clinical research protocols, Cagrilintide is contraindicated in: active pancreatitis or personal history of acute or chronic pancreatitis; pregnancy; breastfeeding/lactation; known hypersensitivity to amylin or its analogs. Concomitant use with insulin or other hypoglycemic agents increases the risk of hypoglycemia.

Cagrilintide in Colombia: Amylin Analog and CagriSema

Mechanism of Action: The Amylin Receptor

Amylin is a pancreatic hormone co-secreted alongside insulin by beta cells. It acts in the brain and gastrointestinal tract to complement insulin: it slows gastric emptying, suppresses post-prandial glucagon, and generates satiety centrally via the area postrema and the nucleus tractus solitarius.(1)

Cagrilintide mimics this effect with a prolonged half-life (approximately 7 days), enabling weekly administration. By activating AMY1, AMY2, and AMY3 receptors, it produces metabolic effects that are distinct from — and complementary to — GLP-1 agonists such as semaglutide.(2)

AMY

Amylin Receptors

Activates AMY1/2/3 in the brainstem and pancreas, with a distinct action profile from GLP-1R.

Gastric Control

Reduces the rate of post-prandial gastric emptying, contributing to prolonged satiety.

Glc

Post-prandial Glucagon

Suppresses glucagon secretion after meals, improving overall glycemic control.

CagriSema: The Most Studied Combination

The CagriSema combination (Cagrilintide 2.4 mg + Semaglutide 2.4 mg, both weekly) is the most advanced formulation in research. By simultaneously targeting the amylin receptor (AMY) and the GLP-1 receptor (GLP-1R), the combination generates an additive or synergistic effect that surpasses each compound individually.(3)

Phase 2 trial data published in 2023 showed that CagriSema participants achieved significantly greater weight reductions compared to semaglutide alone or cagrilintide alone, establishing the rationale for the currently ongoing Phase 3 trials.(3)

Clinical Evidence (Phase 2-3)

~15-20%

Mean weight reduction with CagriSema in Phase 2 trial (REDEFINE) at 32 weeks

Phase 3

REDEFINE 1/2 and SCALE NEXT trials ongoing (Novo Nordisk, 2024-2025)

vs. Sema

CagriSema outperforms semaglutide alone in weight loss across all Phase 2 analyses

The Phase 3 trials REDEFINE 1 (obesity without type 2 diabetes) and REDEFINE 2 (type 2 diabetes with obesity) aim to demonstrate the superiority of CagriSema over semaglutide alone, with results expected in 2025-2026. The SCALE NEXT trial evaluates the combination in long-duration settings.

Contraindications and Safety Warnings

⚠ Important warnings — please read before considering any protocol

No INVIMA approval: Cagrilintide has no regulatory approval from INVIMA, the FDA, or the EMA for clinical use in humans. Use outside authorized clinical trials is not endorsed.
Pancreatitis: Contraindicated in patients with active pancreatitis or a personal history of acute or chronic pancreatitis. Amylin analogs and incretin agonists may be associated with a risk of pancreatic inflammation.
Pregnancy: Contraindicated. No safety data exist for pregnant women; teratogenic potential has not been evaluated.
Breastfeeding / Lactation: Contraindicated. It is unknown whether cagrilintide is excreted in breast milk or what its effect on the infant would be.
Hypoglycemia risk: Concomitant use with insulin, sulfonylureas, or other hypoglycemic agents increases the risk of hypoglycemia. Strict medical supervision and dose adjustment are required.
GI side effects: Nausea, vomiting, and decreased appetite are common at the start of treatment in clinical studies.

Regulatory Status

As of the date this profile was prepared, Cagrilintide has no INVIMA registration in Colombia and is not approved for any clinical indication. Its regulatory category is advanced clinical investigational compound.

The information on this page is intended exclusively for healthcare professionals, researchers, and individuals seeking to understand the current state of the scientific literature on this molecule. It does not constitute a recommendation of use or commercial information.

References

Hay DL, et al. (2015). Amylin: Pharmacology, Physiology, and Clinical Potential. Pharmacological Reviews, 67(3), 564-600.
Enebo LB, et al. (2021). Safety, tolerability, pharmacokinetics, and pharmacodynamics of cagrilintide with semaglutide 2·4 mg for obesity (SCALE NEXT): A randomised, double-blind, placebo-controlled, phase 1 trial. The Lancet.
Funch M, et al. (2023). Weight loss and cardiometabolic risk factors with cagrilintide 2·4 mg alone or in combination with semaglutide 2·4 mg (CagriSema) versus semaglutide 2·4 mg alone in adults with overweight or obesity. The Lancet Diabetes & Endocrinology.
Novo Nordisk (2024). REDEFINE Phase 3 Programme. ClinicalTrials.gov: NCT05959564, NCT05975658.

Cagrilintide