Source: FDA label
| Registered trials | 146 |
|---|---|
| Drug class | GLP-1 Receptor Agonist [EPC] |
| Brand names | TRULICITY |
Boxed warning: The FDA label for this compound includes a boxed warning, the FDA's strongest safety warning. See the full prescribing information for details.
Mechanism of Action
12.1 Mechanism of Action TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.
Overview
Managing blood sugar in type 2 diabetes often means balancing glycemic control against cardiovascular risk. Dulaglutide, sold as Trulicity, is a GLP-1 receptor agonist approved to address both.
Key takeaways
- Dulaglutide is a GLP-1 receptor agonist approved for adults and children 10 and older with type 2 diabetes.
- It also carries an approval to reduce major cardiovascular events in adults with type 2 diabetes and existing heart disease or risk factors.
- The label carries a boxed warning.
- More than 140 registered trials have studied dulaglutide or related compounds across multiple phases.
- FAERS reports for dulaglutide are dominated by gastrointestinal effects and injection-related issues.
What dulaglutide is
Dulaglutide is a human GLP-1 receptor agonist that shares 90% of its amino acid sequence with the body's own GLP-1 hormone. It binds the GLP-1 receptor on pancreatic beta cells, raising intracellular cAMP and triggering insulin release only when blood glucose is elevated. It also lowers glucagon secretion and slows gastric emptying, which together help moderate post-meal blood sugar spikes.
What dulaglutide is approved for
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. The label includes a boxed warning.
What the evidence shows
Dulaglutide and related compounds appear across 146 registered clinical trials. A completed Phase 2 study examined the drug's effects on blood pressure and heart rate in people with type 2 diabetes, while a completed Phase 4 study looked at whether incretin-based therapies like dulaglutide should be held or continued before upper endoscopy procedures.
Reported side effects
FAERS reports for dulaglutide are led by gastrointestinal complaints: nausea (10,199 reports), diarrhoea (5,948), and vomiting (5,608). Injection site pain (9,872 reports) and elevated blood glucose (9,831) are also frequently reported, alongside dosing and administration errors such as incorrect dose given (5,535) and inappropriate scheduling of doses (3,831). Reports of the drug being ineffective (3,602) also appear in the data. These figures reflect submitted reports, not confirmed incidence or proven causation, and they do not account for how many people used the drug overall.
FAQ
What is dulaglutide used for?
Dulaglutide, sold under the brand name Trulicity, is approved as an add-on to diet and exercise to improve blood sugar control in adults and children 10 and older with type 2 diabetes. It is also approved to lower the risk of major cardiovascular events in adults with type 2 diabetes who have heart disease or multiple cardiovascular risk factors.
How does dulaglutide work?
It activates the GLP-1 receptor on pancreatic beta cells, which increases insulin release when blood glucose is high. It also reduces glucagon secretion and slows stomach emptying, helping to moderate blood sugar rises after meals.
Does dulaglutide have a boxed warning?
Yes, the FDA label for dulaglutide (Trulicity) includes a boxed warning. Patients should review the full prescribing information with their healthcare provider for details.
What are the most commonly reported side effects of dulaglutide?
The most frequently reported issues in FAERS data are nausea, diarrhoea, vomiting, and injection site pain, along with reports of elevated blood glucose. Dosing and scheduling errors are also commonly reported. These are counts of submitted reports, not confirmed rates of occurrence.
Has dulaglutide been studied in clinical trials?
Dulaglutide and related compounds have been part of 146 registered clinical trials. Examples include a completed Phase 2 study on blood pressure and heart rate effects and a completed Phase 4 study on managing incretin-based therapy before endoscopy.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication.
Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: DailyMed label (Trulicity) ClinicalTrials.gov FAERS
Updated 2026-08-03