Dulaglutide (Trulicity): evidence and access

Summary

Dulaglutide is an FDA approved once weekly GLP-1 receptor agonist (a drug that mimics GLP-1, a gut hormone that boosts insulin and curbs appetite) sold as Trulicity for type 2 diabetes since 2014, including in children 10 and older since 2022. In the REWIND trial of 9,901 adults it reduced major adverse cardiovascular events (heart attack, stroke, or cardiovascular death) by 12% over a median 5.4 years, the longest follow up of any GLP-1 outcomes trial. It lowers HbA1c (a measure of average blood sugar over about 3 months) by about 1.5 to 1.9 percentage points and causes modest weight loss (3 to 5 kg), but it is not approved for weight management.

What is Dulaglutide?

Dulaglutide is a GLP-1 receptor agonist (two modified GLP-1 analogs fused to a human IgG4 Fc fragment, once weekly). It is also known as Trulicity, LY2189265, GLP-1 Fc fusion.

How does it work?

Dulaglutide consists of two GLP-1 analog chains linked to a modified human IgG4 Fc fragment, which gives a half life of about 5 days. It activates the GLP-1 receptor to increase glucose dependent insulin secretion, suppress glucagon, slow gastric emptying, and reduce appetite. The large Fc fusion means it is a much bigger molecule than semaglutide or liraglutide, which affects how it distributes but not its receptor pharmacology.

Key facts
Cluster	GLP-1 and incretin agonists
Routes	Subcutaneous injection once weekly (single dose pen)
Conditions studied	Type 2 diabetes; Cardiovascular risk reduction
Record	v3, draft, verified Sep 27, 2026

FDA-approved uses of Dulaglutide

Yes. Dulaglutide (Trulicity) has been FDA approved since September 2014 to improve blood sugar in adults with type 2 diabetes, extended to children 10 and older in 2022, and it carries an indication to reduce major adverse cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes and cardiovascular disease or risk factors. It is not approved for weight loss. It is prescription only. [1] [5]

What does the evidence say about Dulaglutide?

Human RCT evidenceGrade assigned per the methodology.

Large randomized controlled trials in type 2 diabetes. REWIND (n = 9,901, median 5.4 years) showed a hazard ratio of 0.88 for major adverse cardiovascular events. AWARD-11 (n = 1,842, 52 weeks) showed that 3.0 mg and 4.5 mg doses lower HbA1c and weight more than 1.5 mg. In head to head trials it has served as an active comparator that was beaten by retatrutide and mazdutide on weight. It has no dedicated obesity trial and no obesity indication.

Indexed studies by evidence grade
Evidence type	Indexed studies	Participants (human)
Human randomized trials	3	12024
Human observational studies	0	n/a
Animal studies	0	n/a
All indexed studies	3	12,024

Human evidence

REWIND: 9,901 adults aged 50 and older with type 2 diabetes and prior cardiovascular disease or risk factors, dulaglutide 1.5 mg weekly versus placebo, median follow up 5.4 years; the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death occurred less often with dulaglutide (hazard ratio 0.88, 95% CI 0.79 to 0.99). AWARD-11: 1,842 adults with type 2 diabetes on metformin randomized to 1.5, 3.0, or 4.5 mg weekly for 52 weeks; escalation to 3.0 and 4.5 mg gave dose related additional HbA1c and weight reductions. Phase 2 comparator data: retatrutide and mazdutide each produced greater weight loss than dulaglutide 1.5 mg in their diabetes trials.

Animal evidence

Preclinical studies established GLP-1 receptor pharmacology and the Fc fusion half life. Rodent studies showed thyroid C cell tumors, the basis of the boxed warning shared across long acting GLP-1 agonists; this has not been reproduced in humans.

Key studies

Indexed studies of Dulaglutide
Study	Design and population	Outcome	Grade
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND)2019 PMID 31189511	Randomized, double blind, placebo controlled cardiovascular outcomes trial, median 5.4 yearsn = 9,901 Adults 50 and older with type 2 diabetes and prior cardiovascular disease or cardiovascular risk factors	Major adverse cardiovascular events hazard ratio 0.88 (95% CI 0.79 to 0.99) with dulaglutide 1.5 mg weekly	Evidence: Human RCT evidence
Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated patients with type 2 diabetes (AWARD-11)2021 PMID 33397768	Randomized, double blind, dose comparison trial, 52 weeksn = 1,842 Adults with type 2 diabetes inadequately controlled on metformin	Escalation to 3.0 mg and 4.5 mg gave dose related additional reductions in HbA1c and body weight versus 1.5 mg	Evidence: Human RCT evidence
Retatrutide for people with type 2 diabetes: a phase 2 trial (dulaglutide 1.5 mg active comparator)2023 PMID 37385280	Randomized, double blind, placebo and active controlled phase 2 trial, 36 weeksn = 281 Adults with type 2 diabetes	Dulaglutide 1.5 mg produced smaller weight and HbA1c reductions than higher dose retatrutide	Evidence: Human RCT evidence

Conditions studied

Conditions with evidence for Dulaglutide
Condition	Grade	Note
Type 2 diabetes	Evidence: Human RCT evidence	FDA approved as Trulicity with cardiovascular outcome data.
Cardiovascular risk reduction	Evidence: Human RCT evidence	REWIND (n = 9,901) found a 12% relative reduction in major adverse cardiovascular events in type 2 diabetes, in a population where most participants had no prior cardiovascular event.

Is Dulaglutide legal in the United States?

FDA approvedNot WADA prohibited

FDA and compounding status

FDA approved product (Trulicity, September 2014; 3.0 mg and 4.5 mg doses added in 2020; pediatric indication in 2022; cardiovascular risk reduction indication based on REWIND). Because dulaglutide is a component of an approved drug, 503A pharmacies may compound it only for a documented patient specific need and may not produce essentially a copy of the commercial product. Dulaglutide is not available in a bulk powder form suitable for compounding. FDA listed dulaglutide injection as in shortage in its October 2024 to February 2025 GLP-1 updates, with all presentations available; it is not listed in FDA's shortage database as of September 27, 2026.

WADA status

Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.

Regulatory timeline

Sep 18, 2014FDA
FDA approves Trulicity (dulaglutide) for type 2 diabetes
FDA approved once-weekly dulaglutide injection (Trulicity) to improve glycemic control in adults with type 2 diabetes.
Regulatory: FDA approvedSource: Drugs@FDA: Trulicity (dulaglutide) BLA 125469

Full tracker for Dulaglutide or the category-wide tracker.

Dulaglutide dosing: FDA label and trial doses

Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.

Trulicity label: 0.75 mg subcutaneously once weekly, increased to 1.5 mg for additional glycemic control, then to 3.0 mg and 4.5 mg after at least 4 weeks on each dose (AWARD-11 regimen). REWIND used 1.5 mg weekly. Pediatric label (age 10 and older): 0.75 mg weekly, may increase to 1.5 mg.

Routes reported

Routes of administration reported for Dulaglutide
#	Route
1	Subcutaneous injection once weekly (single dose pen)

Trulicity side effects in trials

Side effects

Side effects reported for Dulaglutide
#	Reported side effect
1	Nausea (dose dependent, attenuates with continued dosing)
2	Diarrhea
3	Vomiting
4	Abdominal pain
5	Decreased appetite
6	Hypoglycemia when combined with insulin or sulfonylureas
7	Gallbladder disease
8	Pancreatitis (rare)
9	Boxed warning for thyroid C cell tumors based on rodent data
10	In REWIND, gastrointestinal events were the most common reason for discontinuation

Interactions

Interactions reported for Dulaglutide
#	Interaction
1	Insulin and sulfonylureas: increased hypoglycemia risk, dose reduction usually needed
2	Oral medications: delayed gastric emptying may alter absorption; label advises caution with narrow therapeutic window drugs
3	Other GLP-1 or GIP/GLP-1 agonists: not studied in combination and not recommended

Contraindications

Contraindications for Dulaglutide
#	Contraindication
1	Personal or family history of medullary thyroid carcinoma
2	Multiple endocrine neoplasia syndrome type 2
3	Prior serious hypersensitivity to dulaglutide
4	Not for type 1 diabetes or diabetic ketoacidosis

How do people access Dulaglutide legally?

Typical cost: Trulicity list price is 1,006.93 USD per month for four pens at any strength; the manufacturer's self-pay pharmacy sells it from 389 USD per month. With commercial insurance and a manufacturer savings card a covered prescription is often 25 USD per month. Medicare Part D covers it for type 2 diabetes. No generic is available as of the last verified date.

Verified access options

Step 1
Prescription from a licensed provider (in person or telehealth) filled at a retail pharmacy as Trulicity.
Step 2
Not available as a compounded product; dulaglutide is not on any FDA bulks list. FDA listed dulaglutide injection as in shortage, with all presentations available, in its October 2024 to February 2025 GLP-1 updates; it is not listed in FDA's shortage database as of September 27, 2026.
Step 3
Products labeled research use only are not lawful for human use.

Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.

Compare Dulaglutide

Frequently asked questions

Does Trulicity (dulaglutide) cause weight loss?

Modestly. In AWARD-11, 52 weeks of dulaglutide produced dose related weight loss in people with type 2 diabetes, with the 4.5 mg dose losing more than the 1.5 mg dose, in the range of roughly 3 to 5 kg. That is well below semaglutide 2.4 mg or tirzepatide, and in phase 2 diabetes trials dulaglutide 1.5 mg was outperformed on weight by both retatrutide and mazdutide. Trulicity has no weight management indication and no dedicated obesity trial. [2] [3] [4]

What are the side effects of Trulicity?

Gastrointestinal effects dominate: nausea, diarrhea, vomiting, abdominal pain, and reduced appetite, which are dose dependent and fade with continued use; a 4 week pause at each dose step limits them. Serious risks include hypoglycemia with insulin or sulfonylureas, gallbladder disease, and pancreatitis. The label carries a boxed warning for thyroid C cell tumors seen in rodents. In REWIND, gastrointestinal events were the main reason for stopping. [1] [2] [5]

What is the Trulicity dose on the FDA label?

Trulicity is a once weekly injection under the skin of the abdomen, thigh, or upper arm, at any time of day with or without food. Adults start at 0.75 mg weekly, may increase to 1.5 mg after 4 weeks, and can then increase in 1.5 mg steps (3 mg, then 4.5 mg) after at least 4 weeks on each dose; 4.5 mg is the maximum. Children 10 and older start at 0.75 mg and may go to a 1.5 mg maximum. A missed dose is taken only if at least 3 days remain before the next scheduled dose. The prescriber sets the dose. [5]

How much does Trulicity cost?

Trulicity lists at 1,006.93 USD per month regardless of strength, and the manufacturer's self-pay pharmacy sells it from 389 USD per month. Most insured patients pay far less: commercial plans with the manufacturer savings card often bring it to 25 USD per month, and Medicare Part D covers it for type 2 diabetes. There is no generic as of the last verified date. Prices change often. [5] [8] [9]

Is Trulicity (dulaglutide) banned by WADA?

No. GLP-1 receptor agonists including dulaglutide are not on the 2026 WADA Prohibited List or the 2027 list published in September 2026. Athletes with diabetes should still confirm documentation requirements with their anti-doping organization. [6] [7]

Trulicity vs Ozempic: which is better?

For weight and HbA1c, semaglutide generally wins at its higher doses, and semaglutide has approvals for both diabetes and obesity while dulaglutide is diabetes only. Dulaglutide's advantages are the longest cardiovascular follow up (5.4 years in REWIND, hazard ratio 0.88), a pediatric indication, and a simple single use pen. Cost and insurance coverage usually decide between them for diabetes. [1] [2] [5]

Does Trulicity protect the heart?

Yes. REWIND followed 9,901 adults with type 2 diabetes for a median of 5.4 years and found a 12% relative reduction in the composite of nonfatal heart attack, nonfatal stroke, or cardiovascular death (hazard ratio 0.88, 95% CI 0.79 to 0.99). Notably, most participants did not have prior cardiovascular disease, so the benefit extends to a primary prevention population. [1]

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

Peptides for weight loss, ranked by human evidence
Tirzepatide, semaglutide, and liraglutide lead on human trials. Retatrutide is trial-only, and AOD-9604 and 5-amino-1MQ are animal-only. Ranking, legal status, and dated prices.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.

Cite this page

Free to cite and quote with a link. Data is licensed CC BY 4.0 with attribution to PeptideAgent.

APA style: PeptideAgent. (2026, September 27). Dulaglutide: evidence, legality, and access. https://peptideagent.ai/peptides/dulaglutide
HTML link: <a href="https://peptideagent.ai/peptides/dulaglutide">Dulaglutide: evidence, legality, and access</a>, PeptideAgent, updated September 27, 2026.

Dulaglutide (Trulicity)

At a glance