CagriSema: difference between revisions
Diff·revision 16 → 17·22:18, 4 Jul 2025
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| Revision 16 — 14:00, 15 Jun 2025 TrialsTabitha (talk) add see also to the amylin analogue 4,185 bytes +18 | Revision 17 — 22:18, 4 Jul 2025 CustomsClarke (talk) the storage condition applies to the unopened pen; say so 5,302 bytes +1,117 | ||
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| 30 | The adverse-effect profile is that of the two components, dominated by gastrointestinal events. Whether combining two agents that both delay gastric emptying is additive for nausea is not directly addressed by the published designs.{{r|lau2021}} | 30 | The adverse-effect profile is that of the two components, dominated by gastrointestinal events. Whether combining two agents that both delay gastric emptying is additive for nausea is not directly addressed by the published designs.{{r|lau2021}} |
| 31 | 31 | ||
| + | 32 | == Formulation considerations == | |
| + | 33 | A fixed-ratio co-formulation requires that both peptides be stable in the same vehicle at the same pH and concentration for the shelf life of the product. This is a non-trivial constraint: [[Amylin|amylin]] analogues are engineered to resist aggregation but remain more aggregation-prone than acylated incretin analogues, and the buffer that best stabilises one may not best stabilise the other. A specification for a two-component product must accordingly cover both actives and the degradation routes of each.{{r|usp1503,ich_q6b}} | |
| + | 34 | ||
| + | 35 | The combination also fixes the dose ratio across the whole titration, so a participant intolerant of one component cannot reduce it independently. In practice this means escalation is governed by the less tolerated component. | |
| + | 36 | ||
| 32 | == References == | 37 | == References == |
| 33 | {{reflist}} | 38 | {{reflist}} |
| 34 | <ref name="frias2023cagri">Frías JP, Deenadayalan S, Erichsen L, et al. "Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial." ''The Lancet'' 402(10403):720–730 (2023). PMID 37364590.</ref> | 39 | <ref name="frias2023cagri">Frías JP, Deenadayalan S, Erichsen L, et al. "Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial." ''The Lancet'' 402(10403):720–730 (2023). PMID 37364590.</ref> |
| 35 | <ref name="lau2021">Lau DCW, Erichsen L, Francisco AM, et al. "Once-weekly cagrilintide for weight management in people with overweight and obesity." ''The Lancet'' 398(10317):2160–2172 (2021). PMID 34798060.</ref> | 40 | <ref name="lau2021">Lau DCW, Erichsen L, Francisco AM, et al. "Once-weekly cagrilintide for weight management in people with overweight and obesity." ''The Lancet'' 398(10317):2160–2172 (2021). PMID 34798060.</ref> |
| + | 41 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| + | 42 | <ref name="ich_q6b">International Council for Harmonisation, ''Q6B: Specifications — Test Procedures and Acceptance Criteria for Biotechnological/Biological Products'' (1999).</ref> | |
| 36 | 43 | ||
| 37 | == See also == | 44 | == See also == |