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Metabolic

Dulaglutide

Also known as Trulicity · LY2189265 · Dulaglutide (rDNA origin) · GLP-1-Fc fusion protein · Once-weekly GLP-1 receptor agonist (Lilly)

FDA-approvedAHuman trial evidenceWhat this means

Dulaglutide is a once-weekly GLP-1 receptor agonist fusion protein, FDA-approved as Trulicity for glycemic control in type 2 diabetes (adults and children 10 years and older) and for reducing major adverse cardiovascular events in adults with type 2 diabetes.

US status
FDA-approved
Evidence
Grade A
Half-life
Elimination half-life approximately 5 days; median time to peak concentration at steady state 48 hours 1.
Class
GLP-1 receptor agonist (GLP-1 analog-IgG4 Fc fusion protein)
Studied in: Metabolic & insulin research · Class: GLP-1 receptor agonists
More
Log a sample
Dosing referenceCycle-length evidence
Unbranded reference vial illustrating Dulaglutide; not an actual product
Research reference, not advice. Label quotes, not a recommendation. Amiravo sells nothing; some links are referrals.Read the full notice

Key takeaways

  • Dulaglutide is a once-weekly GLP-1 receptor agonist approved as Trulicity for type 2 diabetes in adults and children 10 years and older, and for reducing major cardiovascular events in adults with type 2 diabetes 1.
  • In REWIND (9,901 adults, median 5.4 years), the primary MACE outcome occurred in 12.0% versus 13.4% with placebo (HR 0.88) 1,2.
  • The label carries a boxed warning: dulaglutide caused thyroid C-cell tumors in rats, and it is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2 1.
  • Gastrointestinal reactions were the most common adverse reactions; in the placebo-controlled pool GI reactions occurred in 41% (1.5 mg) versus 21% with placebo 1.
  • Elimination half-life is approximately 5 days 1.

Development stage

Where Dulaglutide sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3
  5. Approved (current)

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Dulaglutide activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells, increasing intracellular cAMP and glucose-dependent insulin release 1.

Pharmacodynamics

  • It decreases glucagon secretion and slows gastric emptying; the delay in gastric emptying is largest after the first dose and diminishes with later doses 1.
  • Both first- and second-phase insulin secretion increased versus placebo in patients with type 2 diabetes 1.

Pharmacokinetics

Mean absolute subcutaneous bioavailability was 65% (0.75 mg) and 47% (1.5 mg); steady state is reached in 2 to 4 weeks; it is presumed to be degraded by general protein catabolism 1.

Research overview

Human research

Approval is based on randomized trials in adults with type 2 diabetes as monotherapy and in combination with other agents, a cardiovascular outcomes trial (REWIND) and a pediatric trial (AWARD-PEDS) 1,2,3,4.

Animal research

In a 2-year rat study, dulaglutide caused dose- and duration-dependent thyroid C-cell tumors; a 6-month rasH2 mouse study showed no increase in C-cell hyperplasia or neoplasia. Rat and rabbit reproduction studies showed fetal effects alongside reduced maternal weight gain 1.

In-vitro research

Dulaglutide is a recombinant protein and no genotoxicity studies have been conducted, according to the label 1.

Key studies

  1. Gerstein et al., Lancet (REWIND, NCT01394952) (2019)
    Multicentre, randomized, double-blind, placebo-controlled cardiovascular outcomes trial, median 5.4 years
    Model: Humans (9,901 adults aged 50 or older with type 2 diabetes and prior CV disease or risk factors)

    Primary MACE outcome 12.0% versus 13.4% (HR 0.88, 95% CI 0.79-0.99); all-cause mortality did not differ significantly (HR 0.90); GI adverse events 47.4% versus 34.1% 2.

  2. Frias et al., Diabetes Care (AWARD-11, NCT03495102) (2021)
    Randomized, double-blind, 52 weeks, primary endpoint at 36 weeks
    Model: Humans (1,842 adults with type 2 diabetes on metformin)

    4.5 mg reduced HbA1c more than 1.5 mg (estimated treatment difference -0.24%); body-weight change -4.6 vs -3.0 kg; nausea 16.4% vs 13.4% 3.

  3. Arslanian et al., N Engl J Med (AWARD-PEDS, NCT02963766) (2022)
    Randomized, double-blind, placebo-controlled, 26 weeks plus 26-week open-label extension
    Model: Humans (154 youths aged 10 to under 18 with type 2 diabetes)

    HbA1c -0.6 and -0.9 points versus +0.6 with placebo; HbA1c below 7.0% in 51% versus 14%; no difference in BMI change 4.

  4. Trulicity prescribing information, Section 14.2 (monotherapy versus metformin) (2026)
    Double-blind randomized trial, primary endpoint 26 weeks
    Model: Humans (807 adults with type 2 diabetes)

    HbA1c change -0.7% and -0.8% with dulaglutide versus -0.6% with metformin; non-inferiority margin excluded 1.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

Full dosing reference, study durations and vial arithmetic →
  • Adults: the recommended starting dosage is 0.75 mg subcutaneously once weekly; after 4 weeks it may be increased to 1.5 mg once weekly for additional glycemic control, and further in 1.5 mg increments after at least 4 weeks on the current dosage, to a maximum of 4.5 mg once weekly 1.
  • Pediatric patients 10 years and older: starting dosage 0.75 mg once weekly; if needed, increase to the maximum of 1.5 mg once weekly after at least 4 weeks 1.
  • Missed dose: give as soon as possible if at least 3 days (72 hours) remain until the next scheduled dose; otherwise skip it 1.
  • Administration and preparation instructions are set out in the prescribing information and are not reproduced here 1.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

Label warnings

  • Boxed warning: dulaglutide causes dose- and duration-dependent thyroid C-cell tumors in rats; human relevance is unknown; contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2 1. 1
  • Acute pancreatitis, including fatal hemorrhagic or necrotizing pancreatitis, has been observed with GLP-1 receptor agonists including Trulicity 1. 1
  • Hypoglycemia risk increases with concomitant insulin secretagogues or insulin 1. 1
  • Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported postmarketing 1. 1
  • Acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions (not recommended in severe gastroparesis), diabetic retinopathy complications in patients with a history of retinopathy, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation 1. 1
  • Nausea
    12.4% (0.75 mg) and 21.1% (1.5 mg) versus 5.3% placebo
    Pool of placebo-controlled adult trials (n=1,670 exposed, mean 23.8 weeks) 1 · GI reactions graded mostly mild or moderate
  • Diarrhea
    8.9% and 12.6% versus 6.7%
    Same pool 1 · Not graded in table
  • Vomiting
    6.0% and 12.7% versus 2.3%
    Same pool 1 · Not graded in table
  • Abdominal pain
    6.5% and 9.4% versus 4.9%
    Same pool 1 · Not graded in table
  • Decreased appetite
    4.9% and 8.6% versus 1.6%
    Same pool 1 · Not graded in table
  • Dyspepsia
    4.1% and 5.8% versus 2.3%
    Same pool 1 · Not graded in table
  • Fatigue
    4.2% and 5.6% versus 2.6%
    Same pool 1 · Not graded in table
  • Sinus tachycardia
    2.8% and 5.6% versus 3.0%
    Placebo-controlled adult trials 1 · Mean heart-rate increase of 2-4 bpm
  • First-degree AV block
    1.7% and 2.3% versus 0.9%
    Placebo-controlled adult trials 1 · Mean PR increase of 2-3 ms

Emerging safety signals

  • Postmarketing reports include ileus, intestinal obstruction, cholecystitis, hepatitis, acute renal failure and alopecia; frequency cannot be reliably estimated from voluntary reports 1. 1 (2026)
  • In REWIND, diabetic retinopathy complications occurred in 8.5% versus 6.2% of patients with baseline retinopathy 1. 1 (2026)
  • Anti-drug antibodies developed in 1.6% of adults in glycemic trials, with no identified clinically significant effect 1. 1 (2026)

What is not known: Whether dulaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans has not been determined 1. Pregnancy data are insufficient to determine drug-associated risk, and there are no data on presence in human milk 1. Safety and effectiveness below 10 years of age have not been established 1. Clinical experience in hepatic impairment is limited 1.

Background viewing

We haven't found a clinician video focused on Dulaglutide yet. Meanwhile, this widely watched talk covers the science of aging in general. It does not discuss Dulaglutide.

David Sinclair, PhD (Harvard Medical School) on the biology of aging
The Diary Of A CEO · 6.9M views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
FDA-approved (initial U.S. approval 2014) as Trulicity, BLA 125469, listed with prescription marketing status as of 2026-10-24 1,5.
United States (FDA)
FDA-approved (initial U.S. approval 2014) under BLA 125469 as Trulicity; Drugs@FDA lists the products with prescription marketing status as of 2026-10-24 1,5.
Sport (WADA)
GLP-1 receptor agonists, including dulaglutide, were not mentioned on the WADA 2026 Prohibited List page reviewed 6.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

Dulaglutide is a roughly 63 kDa recombinant Fc-fusion protein made in mammalian cell culture [1]; it is not a short synthetic peptide, and identity and purity testing for such a product would involve protein-characterization methods rather than a simple peptide mass check.

How purity testing works · Reading a certificate of analysis

Check a Dulaglutide certificate of analysis against its expected mass (63,000 Da)

Storage and handling

The label directs refrigerated storage (2 to 8°C) in the original carton, protected from light and not frozen; a pen may be kept at room temperature up to 30°C for a total of 14 days [1].

Frequently asked questions

What is dulaglutide approved for?
As Trulicity, for glycemic control in adults and children 10 years and older with type 2 diabetes, and to reduce major adverse cardiovascular events in adults with type 2 diabetes and CV disease or risk factors 1.
How does it act?
It activates the GLP-1 receptor, increasing glucose-dependent insulin release, decreasing glucagon and slowing gastric emptying 1.
What did REWIND show?
In 9,901 adults over a median 5.4 years, the composite of CV death, non-fatal MI or non-fatal stroke occurred in 12.0% versus 13.4% with placebo (HR 0.88) 2.
What are the most common adverse reactions?
Nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia and fatigue 1.
Who should not use it according to the label?
People with a personal or family history of medullary thyroid carcinoma or MEN 2, or a prior serious hypersensitivity reaction to dulaglutide 1.
How long does it last in the body?
The label gives an elimination half-life of approximately 5 days 1.
Is it approved for body-weight management?
No; the labeled indications are glycemic control and cardiovascular risk reduction in type 2 diabetes. Body-weight changes were reported as trial outcomes 1,3.

Latest indexed research

Search all studies on Dulaglutide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 24, 2026. Typo and layout fixes are not listed.

  • New section· entryOct 24, 2026

    New research reference added: Dulaglutide.

Last reviewed October 24, 2026 by the Amiravo editorial team.

Read our editorial policy · Report an error on this page

Need the math?

Laboratory arithmetic with every formula shown.

For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page is educational and is not medical advice.

Unbranded reference vial illustrating Dulaglutide; not an actual product

Unbranded reference image. Amiravo does not produce, supply or sell this compound.

Specifications

Molecular weight
63,000 g/mol
Type
Single compound

Chemical identifiers are shown only when verified against PubChem.

Research stats

How much has been published, not how good it is.

PubMed records
1,316
Indexed as human research
835
Animal-only research
49
Randomized controlled trials
147
Registered trials
143
Trials with posted results
61
FDA adverse-event reports (FAERS)
2,394
NIH-funded projects naming it
17
2006: 12007: 02008: 02009: 02010: 12011: 02012: 62013: 22014: 192015: 442016: 582017: 512018: 772019: 932020: 1102021: 1062022: 1122023: 1372024: 1732025: 2322026: 24420062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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