Dulaglutide — compound monograph
GLP-1 receptor agonist, Fc-fusion protein. Approved. The Institute assesses 4 outcomes for this compound and grades the strongest at high certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Dulaglutide
- Compound class
- GLP-1 receptor agonist, Fc-fusion protein
- Assessment series
- Incretin receptor agonists
- Synonyms and codes
- LY2189265 · dulaglutide (INN) · Trulicity (trade)
- 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
- 923950-08-7
- Molecular formula
- not applicable (glycoprotein)
- Average mass
- ≈59,670 Da (63 kDa nominal)
- Monoisotopic mass
- not applicable
- ATC classification
- A10BJ05
§1.3Sequence and structural notes
Unlike the acylated analogues, dulaglutide achieves its long half-life through Fc-mediated recycling via the neonatal Fc receptor. It is a recombinant glycoprotein expressed in mammalian cell culture, not a solid-phase synthetic peptide, and therefore falls outside the analytical framework applicable to synthetic peptides.
§1.4Assessment status
The Institute assesses Dulaglutide across 4 indications and grades the strongest of them at high certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Dulaglutide, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Atherosclerotic cardiovascular disease and cardiovascular risk reduction | MACE hazard ratio 0.88 in a population with a majority without established cardiovascular disease | High | 1 |
| Type 2 diabetes mellitus | −1.1 to −1.9 % HbA1c across the AWARD programme; 4.5 mg gave −1.9 % in AWARD-11 | High | 5 |
| Obesity and overweight in adults | −4.6 kg at 4.5 mg over 52 weeks in type 2 diabetes | Moderate | 1 |
| Chronic kidney disease in type 2 diabetes | Slower eGFR decline versus insulin glargine in moderate-to-severe chronic kidney disease | Low | 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.