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Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment)

Dulaglutide

Approvedaka Trulicity, LY2189265

Dulaglutide is an approved once-weekly GLP-1 therapy for type 2 diabetes. It is a GLP-1 analogue fused to an antibody (IgG4 Fc) fragment, a design that extends its half-life. Randomized trials in the AWARD program show reductions in HbA1c and body weight, and the REWIND trial demonstrated a reduction in major adverse cardiovascular events in a broad type 2 diabetes population. It is not approved as a stand-alone weight-management medicine.

Mechanism

In plain terms, dulaglutide copies a natural gut hormone that lowers blood sugar and curbs appetite. Technically, it is a GLP-1 receptor agonist consisting of GLP-1 analogue peptides covalently linked to a modified human immunoglobulin G4 (IgG4) Fc fragment; the Fc fusion increases molecular size and slows clearance to allow once-weekly dosing. Receptor activation enhances glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying, and reduces food intake.

Regulatory Status by Region

  • United States (FDA)Approved. Trulicity for type 2 diabetes (2014); an indication to reduce major adverse cardiovascular events in adults with type 2 diabetes was added in 2020.
  • Australia (TGA)Registered on the ARTG (Trulicity) for type 2 diabetes, available on prescription.
  • European Union (EMA)Authorized (Trulicity) for type 2 diabetes (marketing authorization granted 2014).
  • WADANot prohibited. GLP-1 receptor agonists are not on the WADA Prohibited List and are not banned substances; the class is tracked under WADA's monitoring program rather than prohibited.

Key Studies

  • Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial (Gerstein et al.) (Lancet 2019;394:121-130; PMID 31189511)
  • Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6; Dungan et al.) (Lancet 2014;384:1349-1357)

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