CagriSema (cagrilintide with semaglutide) — compound monograph
Fixed-ratio combination of a long-acting amylin analogue and a GLP-1 receptor agonist. Phase 3. The Institute assesses 2 outcomes for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- CagriSema (cagrilintide with semaglutide)
- Compound class
- Fixed-ratio combination of a long-acting amylin analogue and a GLP-1 receptor agonist
- Assessment series
- Combinations and unimolecular co-agonists
- Synonyms and codes
- CagriSema · cagrilintide 2.4 mg / semaglutide 2.4 mg · NNC0174-0833 + NN9535
- Route as evaluated
- Subcutaneous once weekly
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- not applicable (combination)
- Molecular formula
- not applicable
- Average mass
- not applicable
- Monoisotopic mass
- not applicable
- ATC classification
- not assigned
§1.3Sequence and structural notes
The combination is a co-formulation, not a chimeric molecule. Analytical characterisation therefore requires a method that resolves and quantifies both actives independently in a single run, together with a content-ratio specification.
§1.4Assessment status
The Institute assesses CagriSema (cagrilintide with semaglutide) across 2 indications and grades the strongest of them at moderate certainty. In confirmatory clinical development; no marketing authorisation.
Table 1. Assessed outcomes for CagriSema (cagrilintide with semaglutide), ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Obesity and overweight in adults | −22.7 % body weight at 68 weeks versus −2.3 % with placebo in adults with obesity without diabetes | Moderate | 3 |
| Type 2 diabetes mellitus | −13.7 % body weight and −1.8 % HbA1c at 68 weeks in type 2 diabetes | Moderate | 1 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.