Cagrilintide¶
Tags: Weight Loss, Amylin Analogue, CagriSema, Type 2 Diabetes
Quick Summary
Cagrilintide is a long-acting lipidated amylin analogue shown to produce substantial weight loss, especially when combined with semaglutide (CagriSema); weekly subcutaneous dosing.
Overview¶
Cagrilintide (AM833) is a long-acting, lipidated amylin analogue that activates amylin and calcitonin receptors. It was developed for weight management and type 2 diabetes, and clinical data show substantial weight loss — especially when combined with semaglutide (the combination is often referred to as "CagriSema"). Recent Phase 3 results report up to ~22.7% mean weight reduction in combination therapy.
Key Benefits¶
- Once-weekly dosing (convenient maintenance)
- Demonstrated large weight-loss efficacy in Phase 3 when combined with semaglutide
- Designed for sustained weight maintenance and metabolic benefits in people with obesity and type 2 diabetes
Mechanism of Action¶
As a lipidated amylin analogue, cagrilintide targets both amylin and calcitonin receptors to increase satiety and modulate metabolic pathways. Lipidation extends circulation time, allowing weekly subcutaneous dosing.
Molecular Information¶
- Weight: 4,409.01 Da
- Length: 37 amino acids
- Type: Amylin receptor agonist (lipidated)
Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe-Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr-Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2
N-terminal lipidation with a γ-glutamic acid spacer and a C20 fatty diacid (pharmaceutical formulations).
Research Indications¶
- Weight loss (most effective; particularly when used with semaglutide)
- Type 2 diabetes with associated weight reduction and improved glycemic control
- Sustained weight maintenance during continued therapy
Research Protocols¶
| Goal | Dose | Frequency | Route |
|---|---|---|---|
| Weight Loss (Monotherapy) | 2.4 mg | Once weekly | Subcutaneous injection |
| Weight Loss (CagriSema) | 2.4 mg + semaglutide 2.4 mg | Once weekly | Subcutaneous injection |
| Type 2 Diabetes Management | 2.4 mg | Once weekly | Subcutaneous injection (often with metformin) |
| Dose Escalation | 0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg | Weekly increases over 16 weeks | Subcutaneous injection |
| Combination Diabetes Therapy | 2.4 mg + SGLT2 inhibitor | Once weekly | Subcutaneous injection |
| Cardiovascular Risk Reduction (REDEFINE 3) | 2.4 mg | Once weekly | Subcutaneous injection |
Timing: administer on the same day each week; evening dosing may reduce morning nausea. Because the route is subcutaneous, it can be given with or without food.
Peptide Interactions¶
Compatible / Complementary
- Semaglutide — Synergistic (combination = CagriSema)
- Tirzepatide — Compatible
- Liraglutide — Compatible
- Metformin — Compatible
- SGLT2 inhibitors — Compatible
- Oral contraceptives — May require timing adjustments
Monitor
- Insulin — Monitor when combined (adjust doses as needed)
- Retatrutide — Use caution and monitor clinically
Avoid
- Pramlintide — Avoid combination
How to Reconstitute (practical notes)¶
- Cagrilintide formulations require an acidic pH (optimal ~3.5–4.5) to avoid fibril formation. Standard bacteriostatic water (pH ~5.5–6) is acceptable for short-term refrigerated use (<30 days), but acidification to ~pH 4.0 (for long-term stability) is recommended in research settings.
- Reconstitute slowly down the vial wall and gently swirl — do not shake.
- Verify pH after reconstitution (3.5–4.5) and ensure the solution is clear; discard if cloudy or if particles are visible.
- Store frozen at -20°C and refrigerate after thawing; inspect for clarity before each injection.
- Allow the vial to warm to room temperature for 15–30 minutes before injection and rotate subcutaneous injection sites weekly.
Quality Indicators¶
Positive Signs
- Pre-filled pen design likely for commercial formulation (post-approval)
- Clinical-grade material shows >98% purity with correct lipidation and folding
- Stable pharmacokinetics support 7-day dosing intervals when stored and handled properly
Warning Signs
- Amylin analogs can form amyloid fibrils at neutral/alkaline pH; maintain acidic conditions to prevent aggregation
What to Expect (timeline)¶
- Week 1–2: GI adaptation, mild nausea possible during dose escalation
- Week 4–8: Early weight loss (approx. 2–5%), reduced appetite
- Week 12–26: Accelerated weight loss (≈10–15%), improved satiety
- Week 26+: Peak efficacy (≈15–23% weight loss when combined with semaglutide), sustained with ongoing therapy
Side Effects & Safety¶
- Most common: gastrointestinal symptoms (nausea, vomiting, diarrhea) during early treatment
- Anti-cagrilintide antibodies are frequently seen (46–73%) but have not been shown to affect efficacy in trials
- No clinically meaningful QT prolongation observed in thorough QT assessments
- Not all patients reach the 2.4 mg target dose (REDEFINE 1 achieved 2.4 mg in ~57.3% of participants)
- Maintain acidic formulation to avoid fibril formation and deamidation; inspect reconstituted solutions before use
References¶
REDEFINE 1 Trial - Phase 3 Weight Loss (2025)
- Humans | 2.4 mg weekly | 68 weeks | 22.7% weight loss vs 2.4% placebo
- Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2502081
REDEFINE 2 Trial - Phase 3 Type 2 Diabetes (2025)
- Humans | 2.4 mg weekly | 68 weeks | 15.7% weight loss, 73.5% achieved HbA1c ≤6.5%
- Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2502082
Phase 2 Type 2 Diabetes Combination Study (2023)
- Humans | 2.4 mg weekly | 32 weeks | 15.6% weight loss, 2.2% HbA1c reduction with CagriSema
- Link: https://www.sciencedirect.com/science/article/abs/pii/S0140673623011637