Cagrilintide (AM833)
Long-Acting Amylin Receptor Agonist · Weight Loss & Diabetes
Overview
Novel long-acting lipidated amylin analog functioning as dual amylin and calcitonin receptor agonist for weight management and type 2 diabetes. Phase 3 trials demonstrate 22.7% weight loss with CagriSema combination.
Subcutaneous injection enables optimal bioavailability, targeting dual amylin and calcitonin receptors for satiety and metabolic regulation. Enhances insulin sensitivity and controls gastric emptying.
Phase 3 trials demonstrate significant weight loss.
22.7% weight loss with CagriSema combination, surpassing existing therapies.
15.7% weight loss in diabetic patients with concurrent glycemic improvements.
2.2% HbA1c reduction with CagriSema versus semaglutide alone.
Mechanism
Novel long-acting lipidated amylin analog functioning as dual amylin and calcitonin receptor agonist for weight management and type 2 diabetes. Phase 3 trials demonstrate 22.7% weight loss with CagriSema combination.
Subcutaneous injection enables optimal bioavailability, targeting dual amylin and calcitonin receptors for satiety and metabolic regulation. Enhances insulin sensitivity and controls gastric emptying.
Phase 3 trials demonstrate significant weight loss.
Research areas
- Novel long-acting lipidated amylin analog functioning as dual amylin and calcitonin receptor agonist for weight management and type 2 diabetes. Phase 3 trials demonstrate 22.7% weight loss with CagriSema combination.
- Subcutaneous injection enables optimal bioavailability, targeting dual amylin and calcitonin receptors for satiety and metabolic regulation. Enhances insulin sensitivity and controls gastric emptying.
- Phase 3 trials demonstrate significant weight loss.
- 22.7% weight loss with CagriSema combination, surpassing existing therapies.
- 15.7% weight loss in diabetic patients with concurrent glycemic improvements.
- 2.2% HbA1c reduction with CagriSema versus semaglutide alone.
- Amylin receptor activation enhances insulin sensitivity and glucose metabolism.
- Dual pathway satiety via amylin and calcitonin receptor activation.
Research notes
- Gastrointestinal effects (nausea, vomiting, diarrhea) during initial weeks
- Anti-cagrilintide antibodies develop in 46-73% but do not affect efficacy
- Only 57.3% achieved maximum 2.4mg dose in REDEFINE 1 trial
- Severe persistent nausea/vomiting preventing hydration
- Pancreatitis signs (severe abdominal pain radiating to back)
- Severe allergic reactions or anaphylaxis
- Significant injection site reactions or abscess formation
- Not recommended in pregnancy or breastfeeding
- Not yet commercially available (FDA approval expected Q1 2026)
Pharmacokinetics
- Subcutaneous injection enables optimal bioavailability, targeting dual amylin and calcitonin receptors for satiety and metabolic regulation. Enhances insulin sensitivity and controls gastric emptying.
References
FAQs
How much weight loss can I expect from CagriSema combination therapy?
Phase 3 REDEFINE trials showed estimated mean weight loss of -20.4% at 68 weeks without diabetes vs -3% placebo. In diabetic patients, CagriSema achieved -13.7% weight loss vs -3.4% placebo. These are the most dramatic weight loss results seen with any approved or experimental therapy to date.
Why do 46-73% of people develop anti-cagrilintide antibodies, and does it matter?
Anti-cagrilintide antibodies develop in roughly half of users, likely due to the peptide being foreign. Remarkably, clinical trial data showed these antibodies do NOT reduce efficacy—weight loss continues despite antibody formation. This unusual finding suggests the antibodies don't significantly neutralize the therapeutic effect.
Why is pH so critical when reconstituting cagrilintide?
Cagrilintide's peptide structure is prone to fibril formation and aggregation at neutral pH. Maintaining pH 3.5-4.5 prevents this self-assembly into inactive clumps. Solution must remain clear; any cloudiness or particles indicate degradation, and the dose should be discarded to avoid injecting aggregated, potentially less potent or harmful material.
When will cagrilintide be available and can I get it now?
Cagrilintide is not yet commercially available. FDA approval is expected Q1 2026. Current access is limited to clinical trial participants. Anyone claiming to sell cagrilintide now is offering an unapproved, likely research-grade product of unknown quality and purity.