Dulaglutide: Weekly GLP-1 Agonist Guide

Before semaglutide became a household name, dulaglutide was the world's best-selling GLP-1 receptor agonist. Marketed as Trulicity by Eli Lilly, it peaked at $7.4 billion in annual revenue in 2022 and spent years as the go-to weekly injectable for type 2 diabetes. Then Ozempic happened, and dulaglutide's dominance faded.

But market performance is not the same thing as clinical value. Dulaglutide's evidence base remains one of the strongest in the GLP-1 class. Its AWARD trial program tested it across nearly every diabetes treatment scenario. And the REWIND cardiovascular outcomes trial did something no other GLP-1 study had done: it showed cardiovascular benefit in a population where the majority of participants did not have established heart disease.

This guide covers everything researchers and clinicians need to know about dulaglutide -- its molecular design, its clinical record, its safety profile, and where it stands today in a GLP-1 market that has shifted dramatically since its 2014 approval.

Quick Facts
What Is Dulaglutide?
Development History
How Dulaglutide Works: Mechanisms of Action
Clinical Research
Administration and Dosing
Safety Profile and Side Effects
Legal and Regulatory Status
Frequently Asked Questions
The Bottom Line

Quick Facts

Property	Detail
Generic Name	Dulaglutide
Brand Name	Trulicity
Manufacturer	Eli Lilly and Company
Drug Class	GLP-1 receptor agonist (incretin mimetic)
Molecular Type	GLP-1 analog fused to modified human IgG4 Fc fragment
Molecular Weight	~59.7 kDa (homodimer)
Route of Administration	Subcutaneous injection
Dosing Frequency	Once weekly
Available Doses	0.75 mg, 1.5 mg, 3.0 mg, 4.5 mg
Half-Life	~5 days
FDA Approval	September 2014
Primary Indication	Type 2 diabetes mellitus (as adjunct to diet and exercise)
Cardiovascular Indication	Reduction of major adverse cardiovascular events in adults with type 2 diabetes and established or at-risk cardiovascular disease
Storage	Refrigerated (2-8°C); can be kept at room temperature for up to 14 days

What Is Dulaglutide?

Dulaglutide is a long-acting GLP-1 receptor agonist designed for once-weekly subcutaneous injection. It belongs to the incretin mimetic class of diabetes medications, which work by mimicking the gut hormone glucagon-like peptide-1.

At the molecular level, dulaglutide is an engineered fusion protein. It consists of two modified GLP-1 analog sequences, each covalently linked to a modified human immunoglobulin G4 (IgG4) Fc fragment through a small peptide linker. The resulting homodimer weighs roughly 59.7 kilodaltons -- far larger than native GLP-1, which is a 30-amino-acid peptide that gets chewed up by DPP-4 enzymes within minutes of release.

This design is what gives dulaglutide its long duration of action. The IgG4 Fc fragment does three things: it protects the GLP-1 moiety from enzymatic degradation, it reduces renal clearance due to sheer molecular size, and it enables FcRn-mediated recycling -- the same mechanism that gives natural antibodies their long circulating life. The GLP-1 portion itself has been modified at several amino acid positions to further resist DPP-4 cleavage while retaining strong binding affinity for the GLP-1 receptor.

The net result is a molecule with a half-life of approximately five days, long enough to maintain therapeutic drug levels with a single weekly injection. This approach differs from how other long-acting GLP-1 agonists achieve their extended action. Semaglutide uses fatty acid acylation to bind albumin. Exenatide extended-release uses microsphere encapsulation. Liraglutide relies on albumin binding through a C16 fatty acid chain but requires daily dosing. Dulaglutide's Fc fusion strategy was a distinct engineering choice that turned out to produce reliable weekly coverage.

Development History

Dulaglutide was developed entirely by Eli Lilly and Company, building on the pharmaceutical industry's growing understanding of incretin biology in the 2000s.

The drug moved through clinical development under the code name LY2189265. Eli Lilly filed for FDA approval based on data from the AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) clinical trial program, which began in 2011 and eventually grew to include 11 completed phase 3 studies.

The FDA approved dulaglutide (as Trulicity) on September 18, 2014, for the treatment of type 2 diabetes as an adjunct to diet and exercise. It was the fifth GLP-1 receptor agonist to reach the US market, following exenatide (Byetta, 2005), liraglutide (Victoza, 2010), exenatide extended-release (Bydureon, 2012), and albiglutide (Tanzeum, 2014). It was the third to offer once-weekly dosing.

What set Trulicity apart commercially was its injection device. Lilly designed a single-use, pre-filled, auto-injector pen with a hidden needle -- patients never see or handle the needle. This turned out to matter enormously for real-world adherence. Many patients with diabetes have injection anxiety, and the Trulicity pen consistently scored high in patient preference studies compared to other injectable devices.

By 2020, Trulicity had become the world's best-selling GLP-1 receptor agonist, surpassing Victoza (liraglutide). It peaked at roughly $7.4 billion in global sales in 2022.

In 2020, the FDA expanded Trulicity's label to include reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors, based on data from the REWIND trial. This made it one of only a few GLP-1 agonists with a formal cardiovascular indication.

In 2020, Lilly also received FDA approval for two higher doses -- 3.0 mg and 4.5 mg -- based on the AWARD-11 trial, providing more dose flexibility for patients needing additional glycemic control. The original approval had included only the 0.75 mg and 1.5 mg doses.

How Dulaglutide Works: Mechanisms of Action

Dulaglutide's effects flow from a single upstream event: activation of the GLP-1 receptor (GLP-1R), a G-protein-coupled receptor expressed on pancreatic beta cells, the gastrointestinal tract, the central nervous system, and the cardiovascular system.

When dulaglutide binds GLP-1R, it triggers a cascade of intracellular signaling through cyclic AMP (cAMP) and other pathways. The downstream effects can be grouped into several categories.

Glucose-Dependent Insulin Secretion

Dulaglutide increases insulin release from pancreatic beta cells, but only when blood glucose is elevated. This glucose-dependent mechanism is a defining feature of the GLP-1 class and is the main reason these drugs carry a lower hypoglycemia risk than sulfonylureas or exogenous insulin. When glucose levels drop to normal, the insulinotropic signal fades.

Glucagon Suppression

The drug simultaneously suppresses glucagon secretion from pancreatic alpha cells, again in a glucose-dependent manner. Since glucagon drives hepatic glucose output, lowering it helps bring down fasting and postprandial blood sugar. In phase 3 monotherapy studies, dulaglutide 0.75 mg and 1.5 mg reduced fasting glucagon concentrations by 1.71 and 2.05 pmol/L from baseline, respectively (Smith et al., 2016).

Delayed Gastric Emptying

Like other GLP-1 agonists, dulaglutide slows the rate at which the stomach empties food into the small intestine. This has a direct effect on postprandial glucose spikes -- food enters the bloodstream more gradually, giving insulin time to match the glucose load. The gastric emptying effect is strongest after the first dose and tends to diminish somewhat with continued treatment (Trulicity prescribing information, Eli Lilly).

Appetite Reduction and Weight Loss

GLP-1 receptors in the hypothalamus and brainstem regulate hunger and satiety signaling. Dulaglutide activates these receptors, reducing appetite and food intake. Across the AWARD program, patients on dulaglutide consistently lost weight -- typically 1 to 3 kg more than comparator groups over 26 to 52 weeks. The weight loss is modest compared to what semaglutide or tirzepatide can achieve at higher doses, but it is a clear and reproducible effect.

Cardiovascular Effects

GLP-1 receptors are expressed in cardiac tissue and the vasculature. Beyond glucose lowering, dulaglutide appears to exert direct cardiovascular effects -- reducing systolic blood pressure, improving endothelial function, and modifying lipid profiles. The REWIND trial showed a 12% reduction in major cardiovascular events. Post-hoc analyses suggested that 42-65% of dulaglutide's cardiovascular benefit may be mediated through non-glycemic pathways including changes in waist circumference, LDL cholesterol, and urinary albumin-to-creatinine ratio (Konig et al., 2021).

Clinical Research

Dulaglutide's clinical evidence base is built on two main pillars: the AWARD trial program (glycemic efficacy and safety) and the REWIND trial (cardiovascular outcomes).

The AWARD Program

The AWARD program comprised 11 phase 3 randomized controlled trials enrolling thousands of adults with type 2 diabetes across a wide range of treatment backgrounds. These trials tested dulaglutide at various doses against placebo and active comparators including metformin, sitagliptin, exenatide, liraglutide, insulin glargine, and SGLT2 inhibitors (Jendle et al., 2016).

Key findings across the program:

AWARD-1 tested dulaglutide 0.75 mg and 1.5 mg against exenatide 10 mcg twice daily (plus metformin and pioglitazone background). At 26 weeks, dulaglutide 1.5 mg reduced HbA1c by 1.5% versus 1.0% for exenatide -- a statistically significant difference (Wysham et al., 2014).

AWARD-3 compared dulaglutide monotherapy to metformin in treatment-naive patients. Both dulaglutide doses (0.71% and 0.78% HbA1c reduction) were superior to metformin (0.56%) at 26 weeks (Umpierrez et al., 2014).

AWARD-5 showed dulaglutide 1.5 mg and 0.75 mg were both superior to sitagliptin 100 mg daily at 52 weeks, with HbA1c reductions of 1.10%, 0.87%, and 0.39%, respectively (Nauck et al., 2014).

AWARD-6 was a head-to-head non-inferiority study against liraglutide 1.8 mg daily. Dulaglutide 1.5 mg met the primary endpoint of non-inferiority for HbA1c reduction at 26 weeks, making it the first once-weekly GLP-1 agonist to demonstrate non-inferiority against liraglutide (Dungan et al., 2014).

AWARD-10 tested dulaglutide as an add-on to SGLT2 inhibitor therapy -- one of the first GLP-1 trials to examine this combination. Dulaglutide 1.5 mg added to an SGLT2 inhibitor reduced HbA1c by 1.34% versus 0.54% for placebo (Ludvik et al., 2018).

AWARD-11 (2021) established the safety and efficacy of the higher 3.0 mg and 4.5 mg doses. In metformin-treated patients, dulaglutide 4.5 mg achieved an HbA1c reduction of 1.77% at 36 weeks, versus 1.54% for 1.5 mg -- with correspondingly greater weight loss (Frias et al., 2021).

Across the full program, dulaglutide showed superiority to the active comparator in four of five head-to-head AWARD studies. Gastrointestinal side effects (nausea, diarrhea, vomiting) were the most commonly reported adverse events, consistent with the GLP-1 class.

The REWIND Trial

REWIND (Researching Cardiovascular Events with a Weekly Incretin in Diabetes) was a landmark cardiovascular outcomes trial -- and the one that most distinguishes dulaglutide's evidence base from its competitors.

Published in The Lancet in 2019, REWIND randomized 9,901 adults with type 2 diabetes to dulaglutide 1.5 mg weekly or placebo, with a median follow-up of 5.4 years -- the longest follow-up of any GLP-1 cardiovascular outcomes trial at the time of publication (Gerstein et al., 2019).

What made REWIND unique was its study population. Most prior GLP-1 cardiovascular trials (including LEADER for liraglutide and SUSTAIN 6 for semaglutide) enrolled predominantly patients with established cardiovascular disease. REWIND enrolled a broader population: only 31.5% of participants had established cardiovascular disease at baseline. The majority (68.5%) were enrolled based on cardiovascular risk factors alone -- things like hypertension, dyslipidemia, smoking, or microalbuminuria.

The primary endpoint was a composite of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death (three-point MACE). Dulaglutide reduced this composite by 12% (hazard ratio 0.88; 95% CI 0.79-0.99; p=0.026).

Exploratory analyses revealed additional findings:

Stroke reduction: Dulaglutide reduced the incidence of non-fatal stroke by 24% (HR 0.76, 95% CI 0.61-0.95), a particularly striking result (Gerstein et al., 2020).
Renal protection: Dulaglutide reduced the composite renal outcome (new macroalbuminuria, sustained decline in eGFR of 30% or more, or chronic renal replacement therapy) by 15% (Gerstein et al., 2019).
Cognitive outcomes: An exploratory analysis found that dulaglutide reduced the risk of cognitive impairment (as measured by the Montreal Cognitive Assessment and the Digit Symbol Substitution Test) (Cukierman-Yaffe et al., 2020).

The REWIND results were significant because they suggested GLP-1 receptor agonists could provide cardiovascular protection in a wider type 2 diabetes population -- not just those who already had heart disease. This expanded the clinical rationale for earlier GLP-1 use in the disease course.

Head-to-Head vs. Semaglutide: SUSTAIN 7

The SUSTAIN 7 trial, published in The Lancet Diabetes & Endocrinology in 2018, was the head-to-head comparison that redefined dulaglutide's competitive position. This open-label, phase 3b trial compared once-weekly semaglutide (0.5 mg and 1.0 mg) against once-weekly dulaglutide (0.75 mg and 1.5 mg) in 1,201 adults with type 2 diabetes on metformin background therapy (Pratley et al., 2018).

At 40 weeks, semaglutide was superior to dulaglutide at both dose comparisons:

Low dose: Semaglutide 0.5 mg reduced HbA1c by 1.5% versus 1.1% for dulaglutide 0.75 mg.
High dose: Semaglutide 1.0 mg reduced HbA1c by 1.8% versus 1.4% for dulaglutide 1.5 mg.
Weight loss: Semaglutide produced significantly greater weight loss at both dose levels -- an average of 4.6 kg versus 2.3 kg at low doses, and 6.5 kg versus 3.0 kg at high doses.

Safety profiles were broadly similar, with gastrointestinal events being the most common adverse effects in both groups. SUSTAIN 7 is the main reason semaglutide displaced dulaglutide as the preferred weekly GLP-1 in many treatment guidelines. However, it is worth noting that SUSTAIN 7 compared the original, lower doses of dulaglutide (0.75 mg and 1.5 mg) -- the 3.0 mg and 4.5 mg doses approved in 2020 were not yet available.

Administration and Dosing

Dulaglutide is injected subcutaneously once weekly, on the same day each week, at any time of day, with or without meals. The injection can be given in the abdomen, thigh, or upper arm. Patients should rotate injection sites with each dose.

Dose Escalation

The recommended starting dose is 0.75 mg once weekly. If additional glycemic control is needed, the dose can be increased to 1.5 mg, then to 3.0 mg, and up to a maximum of 4.5 mg once weekly. Each dose escalation should occur after at least four weeks at the current dose.

Injection Device

Trulicity comes in a single-use, pre-filled pen with a hidden, pre-attached needle. The patient unlocks the pen, places it against the skin, and presses a button. The injection takes about 5 to 10 seconds. The needle retracts automatically after injection. There is no need to handle, attach, or dispose of a separate needle. This design was a deliberate effort by Eli Lilly to address needle phobia and simplify the injection process.

Missed Doses

If a dose is missed, it should be administered as soon as possible within 3 days (72 hours) of the scheduled dose. If more than 72 hours have passed, the missed dose should be skipped and the next dose taken on the regularly scheduled day. The once-weekly injection day can be changed as long as the last dose was administered 3 or more days before.

Special Populations

No dose adjustment is required for patients with renal impairment, hepatic impairment, or the elderly. However, renal function should be monitored in patients reporting severe gastrointestinal reactions, as dehydration from nausea, vomiting, or diarrhea can worsen kidney function. Dulaglutide has not been studied in patients with severe gastrointestinal disease and is not recommended in this population.

Safety Profile and Side Effects

Dulaglutide's safety profile is well characterized across tens of thousands of patient-years of exposure from the AWARD program, REWIND, and post-marketing surveillance.

Common Side Effects

The most frequently reported adverse reactions (occurring in 5% or more of patients) are gastrointestinal:

Nausea (12-21%, dose-dependent)
Diarrhea (8-12%)
Vomiting (6-12%)
Abdominal pain (6-9%)
Decreased appetite (4-8%)
Dyspepsia (4-6%)
Fatigue (4-6%)

These GI effects are typical of the GLP-1 class and tend to be most pronounced during the first 2 to 4 weeks of treatment, decreasing with continued use. They are usually mild to moderate in severity and rarely require discontinuation.

Serious Warnings

Dulaglutide carries a boxed warning regarding the risk of thyroid C-cell tumors. In rodent studies, GLP-1 receptor agonists caused dose-dependent thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether dulaglutide causes thyroid C-cell tumors in humans. The drug is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Other serious risks include:

Pancreatitis: Acute pancreatitis has been reported. Dulaglutide should be discontinued if pancreatitis is suspected.
Hypoglycemia: Risk increases when used with insulin secretagogues (sulfonylureas) or insulin. Dose reduction of the concomitant agent may be necessary.
Acute kidney injury: Reported in post-marketing surveillance, typically associated with dehydration from GI side effects.
Hypersensitivity reactions: Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported.
Diabetic retinopathy: Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy in some studies, though this is a class-wide concern rather than specific to dulaglutide.

Cardiac Safety

Dulaglutide does not produce QTc prolongation based on thorough QT studies. In REWIND, there was no increase in heart failure hospitalizations. A post-hoc analysis actually suggested potential benefit for heart failure outcomes in patients treated with dulaglutide (Branch et al., 2022).

Immunogenicity

Anti-dulaglutide antibodies have been detected in a small percentage of treated patients (approximately 1-3%). In most cases, these antibodies had no effect on pharmacokinetics or clinical efficacy.

Legal and Regulatory Status

United States

Dulaglutide is FDA-approved as a prescription medication for:

Treatment of type 2 diabetes mellitus as an adjunct to diet and exercise
Reduction of the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors

It is available in four dose strengths: 0.75 mg, 1.5 mg, 3.0 mg, and 4.5 mg, all as single-use pre-filled pens. Trulicity is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.

Europe

Dulaglutide is approved by the European Medicines Agency (EMA) under the brand name Trulicity, with similar indications to the US label.

Global Approvals

Trulicity is approved in over 60 countries worldwide, including Japan, Canada, Australia, and numerous markets across Asia and Latin America.

Patent and Market Status

Eli Lilly holds multiple patents covering dulaglutide's composition, formulation, and delivery device. Core patents begin expiring around 2027-2029, which will eventually open the door for biosimilar competition. As of early 2026, no biosimilar dulaglutide has been approved in the US.

Current Market Position

Trulicity's sales peaked at $7.4 billion in 2022 but have been declining as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) have captured market share. Revenue fell to approximately $5.3 billion in 2024. Within Eli Lilly's own portfolio, Mounjaro and Zepbound now generate significantly more revenue than Trulicity. Despite this decline, Trulicity remains one of the top-selling diabetes drugs globally and maintains a large patient base, particularly among patients who are stable on the drug and have no clinical reason to switch.

Frequently Asked Questions

How does dulaglutide compare to semaglutide?

In the SUSTAIN 7 head-to-head trial, semaglutide was superior to dulaglutide at both low and high dose comparisons for HbA1c reduction and weight loss. At the highest tested doses, semaglutide 1.0 mg reduced HbA1c by 1.8% and body weight by 6.5 kg, versus 1.4% and 3.0 kg for dulaglutide 1.5 mg. However, dulaglutide's higher doses (3.0 mg and 4.5 mg) were not yet available when SUSTAIN 7 was conducted. No head-to-head trial has compared semaglutide against these newer dulaglutide doses. Read more in our semaglutide profile.

Is dulaglutide approved for weight loss?

No. Unlike semaglutide (which is approved for weight management as Wegovy) or liraglutide (approved as Saxenda), dulaglutide does not have an FDA-approved indication for obesity or weight management. Weight loss does occur as a secondary effect during diabetes treatment -- typically 1.5 to 4.5 kg depending on dose -- but it is less than what semaglutide or tirzepatide produce.

What makes the REWIND trial unique among GLP-1 cardiovascular studies?

REWIND stands out for three reasons: its study population included a majority of patients (68.5%) without established cardiovascular disease, relying instead on cardiovascular risk factors; its median follow-up of 5.4 years was the longest of any GLP-1 cardiovascular outcomes trial; and it enrolled participants with a relatively low baseline HbA1c (mean 7.2%), suggesting cardiovascular benefit is not dependent on large glucose reductions.

Can dulaglutide be used with insulin?

Yes. Dulaglutide can be added to basal insulin therapy. In the AWARD-9 study, dulaglutide added to insulin glargine significantly improved glycemic control compared to placebo. When combining dulaglutide with insulin, clinicians may need to lower the insulin dose to reduce hypoglycemia risk.

How does dulaglutide compare to newer dual and triple agonists?

Newer agents like tirzepatide (a dual GIP/GLP-1 agonist) and investigational compounds like retatrutide (a triple GLP-1/GIP/glucagon agonist) produce substantially greater HbA1c reductions and weight loss than dulaglutide. In the SURPASS-1 through SURPASS-5 trials, tirzepatide outperformed dulaglutide on every primary endpoint. These newer molecules represent the next evolution in incretin-based therapy. See also our profiles of survodutide, orforglipron, CagriSema, and pemvidutide for ongoing developments in this space.

What is the injection experience like?

Trulicity uses a single-use, pre-filled auto-injector pen with a hidden needle. Patients never see or handle the needle. You unlock the base, place the pen against the skin, press a button, wait for a click, and remove. The entire process takes seconds. Patient satisfaction surveys have consistently rated the Trulicity pen highly for ease of use.

Does dulaglutide interact with other medications?

Because dulaglutide delays gastric emptying, it can theoretically slow the absorption of concomitant oral medications. This is a class-wide concern. Medications with a narrow therapeutic index should be monitored appropriately. No clinically significant pharmacokinetic drug interactions have been identified in dedicated studies with commonly used diabetes medications.

The Bottom Line

Dulaglutide does not generate the headlines it once did. In a field now dominated by semaglutide and tirzepatide, the drug that was once the world's top GLP-1 has been gradually eclipsed on both glycemic efficacy and weight loss.

But clinical medicine is not a popularity contest, and dulaglutide's evidence base remains formidable. The AWARD program provided a rare breadth of comparative data across treatment contexts. REWIND demonstrated cardiovascular protection in a population where most patients did not yet have heart disease -- a finding that influenced treatment guidelines and expanded the clinical argument for earlier GLP-1 use. The drug's stroke reduction data is among the most compelling in the class.

For patients already stable on dulaglutide with good glycemic control, there is no clinical imperative to switch. For new patients considering a GLP-1 for the first time, semaglutide and tirzepatide generally offer more potent glucose lowering and weight loss. But dulaglutide, with its user-friendly injection device, well-understood safety profile, and strong cardiovascular data, remains a legitimate option -- particularly for patients who prioritize simplicity, tolerability, and long-term cardiovascular evidence.

The story of dulaglutide is, in many ways, the story of how fast the GLP-1 field has moved. A drug that was a clear market leader just a few years ago is now the option patients graduate from rather than to. That does not erase its contributions to the science or its value for the millions of people still taking it.

Related Peptide Profiles: BPC-157 | AOD-9604 | Tesamorelin

This article is for educational and informational purposes only. It does not constitute medical advice. Consult a qualified healthcare provider before starting, stopping, or changing any medication.

References

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Trulicity (dulaglutide) Prescribing Information. Eli Lilly and Company. 2024. FDA Label

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