Dulaglutide

Trulicity

Grade A: Approved and proven

TL;DR: Dulaglutide (Trulicity) is an FDA-approved once-weekly GLP-1 receptor agonist for type 2 diabetes with an extensive clinical evidence base. The AWARD trial series demonstrated consistent reductions in HbA1c across a range of backgrounds and comparators. The REWIND cardiovascular outcomes trial enrolled approximately 9,900 patients with type 2 diabetes, including a high proportion (about 68%) without prior cardiovascular events, over a median of 5.4 years and showed a significant 12% relative reduction in major adverse cardiovascular events; this broad enrollment profile is notable among GLP-1 cardiovascular outcomes trials. Dulaglutide is not approved for chronic weight management as a primary indication, though modest weight reduction is observed. The SURPASS-CVOT trial published results showing tirzepatide was non-inferior to dulaglutide for MACE in type 2 diabetes with established cardiovascular disease, with tirzepatide producing greater metabolic and weight benefits. Evidence supporting type 2 diabetes treatment is grade A and well-established.

Key Takeaways

Grade A: Approved and proven
FDA approved: Approved as Trulicity (once-weekly subcutaneous injection) for glycemic control in type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
Compounding: FDA-approved; brand name Trulicity; no mass compounding indications apply to an approved, in-market product. Generic development status unclear as of mid-2026.

Mechanism

Dulaglutide is a GLP-1 receptor agonist that promotes glucose-dependent insulin secretion, suppresses glucagon release, slows gastric emptying, and reduces food intake.

Evidence

Dulaglutide (Trulicity) is an FDA-approved once-weekly GLP-1 receptor agonist for type 2 diabetes with an extensive clinical evidence base. The AWARD trial series demonstrated consistent reductions in HbA1c across a range of backgrounds and comparators. The REWIND cardiovascular outcomes trial enrolled approximately 9,900 patients with type 2 diabetes, including a high proportion (about 68%) without prior cardiovascular events, over a median of 5.4 years and showed a significant 12% relative reduction in major adverse cardiovascular events; this broad enrollment profile is notable among GLP-1 cardiovascular outcomes trials. Dulaglutide is not approved for chronic weight management as a primary indication, though modest weight reduction is observed. The SURPASS-CVOT trial published results showing tirzepatide was non-inferior to dulaglutide for MACE in type 2 diabetes with established cardiovascular disease, with tirzepatide producing greater metabolic and weight benefits. Evidence supporting type 2 diabetes treatment is grade A and well-established.

Safety and risks

Boxed warning: dulaglutide causes thyroid C-cell tumors in rats in a dose- and duration-dependent manner; human relevance is unknown. Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); one case of MTC was reported during the clinical trial program. Patients should report any neck lump, hoarseness, difficulty swallowing, or dyspnea. Acute pancreatitis has been reported; discontinue if severe persistent upper abdominal pain occurs, and do not restart if pancreatitis is confirmed. Gallbladder disease including cholelithiasis and cholecystitis has been reported; monitor for biliary symptoms. Hypoglycemia risk is substantially elevated when co-administered with insulin secretagogues or insulin. Serious hypersensitivity reactions have been reported. The most common adverse effects are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Interactions

Increased hypoglycemia risk when combined with insulin or sulfonylureas; dose reduction of the secretagogue or insulin may be needed. Delayed gastric emptying may affect oral drug absorption.

Federal compounding status

FDA-approved drug as of 2026-06-02.

An FDA-approved drug that should be obtained as the licensed product. It is not a 503A bulk-substance candidate; compounding from bulk is limited under federal rules and generally permitted only during a declared shortage.

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

FDA-approved; brand name Trulicity; no mass compounding indications apply to an approved, in-market product. Generic development status unclear as of mid-2026.

Sources

Dulaglutide is FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).