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This page remains under independent editorial review (reviewPending). Visible in the wiki but noindexed until gate. Educational reference only — not prescribing advice.
BOXED WARNING — Thyroid C-cell tumors
US labelling carries a boxed warning for thyroid C-cell tumors observed in rodents. Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Counsel patients on symptoms of thyroid tumors. Human relevance of rodent C-cell findings is uncertain — the warning remains on the USPI.
Section 1 of 8Overview
Overview
Dulaglutide (brand Trulicity; Lilly code LY2189265) is an FDA- (2014) and EMA-approved once-weekly GLP-1 receptor agonist. Chemically it is a recombinant fusion protein: two GLP-1 analogue domains (~90% homology to human GLP-1(7–37) in the peptide portion) linked to a modified human IgG4 Fc, at about 63 kDa. There is no small-molecule PubChem CID (expected for a biologic of this size). Plasma half-life is about 5 days, supporting weekly injection.
Section 2 of 8Indications (label-level)
Indications (label-level)
- Glycemic control in type 2 diabetes — adults and pediatrics ≥10 years (US/EMA framing).
- Reduce MACE (CV death, non-fatal MI, non-fatal stroke) in adults with T2D and established CVD or multiple CV risk factors (FDA; CV data summarised in EMA SmPC §5.1).
Not indicated for type 1 diabetes or diabetic ketoacidosis. Unlike semaglutide as Wegovy, dulaglutide does not carry a separate US chronic weight-management brand indication.
Section 3 of 8Label dosing (citation only)
Label dosing (citation only)
Dosing is defined only by the official labels and is not reproduced here: Trulicity prescribing information (DailyMed) (opens in a new tab) and Trulicity EPAR (EMA) (opens in a new tab). Label citation only — not a self-use protocol.
Section 4 of 8Key evidence
Key evidence
| Study | Design | Result | Source |
|---|---|---|---|
| REWIND | Phase 3 CVOT; n=9901; median 5.4 y; 1.5 mg vs placebo | MACE HR 0.88 (0.79–0.99); p=0.026 | PMID 31189511; NCT01394952 |
| AWARD-11 | Dose comparison 1.5 / 3 / 4.5 mg + metformin | Higher doses → greater HbA1c and weight reduction | PMID 33397768 |
| AWARD programme | Glycemic RCTs | Foundation for the initial approval | Label §14 |
REWIND enrolled a mixed primary-/secondary-prevention diabetes population with relatively lower baseline HbA1c than many other CVOTs — useful context when comparing MACE effect sizes across drugs.
Section 5 of 8Safety (beyond the boxed warning)
Safety (beyond the boxed warning)
Common adverse reactions: nausea, diarrhea, vomiting, abdominal pain, decreased appetite. Other labelled warnings include pancreatitis, hypoglycemia when combined with insulin/sulfonylurea, acute kidney injury with volume depletion, severe GI disease (avoid in severe gastroparesis), diabetic retinopathy complications, gallbladder disease, and perioperative pulmonary aspiration risk (class labelling).
Section 6 of 8Comparison snapshot
Comparison snapshot
| Liraglutide | Dulaglutide | Semaglutide | Tirzepatide | |
|---|---|---|---|---|
| Schedule | Daily | Weekly | Weekly (inj) / oral | Weekly |
| Structure | Acylated GLP-1 | Fc fusion | Acylated GLP-1 | Dual GIP/GLP-1 |
| Landmark CVOT | LEADER | REWIND | SUSTAIN-6 / SELECT | SURPASS-CVOT programme |
| Typical weight vs high-dose sema | Smaller | Smaller | Larger | Often largest (dual) |
Also see exenatide for an earlier GLP-1 RA lineage.
Section 7 of 8Claims vs evidence
Claims vs evidence
| Claim | Assessment |
|---|---|
| Approved QW GLP-1 for T2D + MACE risk reduction | Supported |
| Obesity indication like Wegovy | No |
| No boxed warning | False |
| Research “dulaglutide vials” = Trulicity | False — prescription biologic |