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Dulaglutide

GLP-1 receptor agonist (Fc fusion protein)

Status

Approved

Approved by the FDA and EMA in 2014 for type 2 diabetes (now including children 10 and older), with a US indication to reduce major cardiovascular events; unlike most drugs in this class it is a biologic made in mammalian cell culture, so it is not a synthetic peptide.

Evidence

Strong

The AWARD phase 3 program and the REWIND cardiovascular outcomes trial (9,901 participants) support its approved uses.

Dulaglutide is a once-weekly injected GLP-1 receptor agonist made by fusing two GLP-1 analog peptides to an antibody Fc fragment. It is approved for type 2 diabetes in adults and children 10 and older, and in the US to reduce cardiovascular events.

Structure

31 residues
  1. aG31Continues through a 16-residue Gly-Ser linker (GGGGSGGGGSGGGGSA) into a modified human IgG4 Fc domain

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

Sequence as text
GLP-1 analog segment (N-terminus of each Fc-fusion chain): H-H-G-E-G-T-F-T-S-D-V-S-S-Y-L-E-E-Q-A-A-K-E-F-I-A-W-L-V-K-G-G-G-OH

What it is used for

  • Type 2 diabetes in adults and children 10 and older, glycemic control (approved)
  • Reducing major cardiovascular events in type 2 diabetes with cardiovascular disease or multiple risk factors (approved)

How it works

Each dulaglutide chain carries a GLP-1 analog that activates the GLP-1 receptor, increasing glucose-dependent insulin release, lowering glucagon and slowing stomach emptying. Changes near the N-terminus reduce breakdown by the enzyme DPP-4, and fusion to a modified IgG4 Fc fragment makes the molecule large and long-lived, giving a half-life of about five days. The Fc portion is engineered to avoid binding high-affinity Fc receptors.

How strong the evidence is

StrongSeveral large randomised controlled trials in people.

REWIND (9,901 people with type 2 diabetes, mostly without prior cardiovascular disease) found fewer major cardiovascular events with dulaglutide 1.5 mg than placebo over a median 5.4 years (12.0% vs 13.4%; hazard ratio 0.88). AWARD-11 (1,842 metformin-treated patients) showed that the 4.5 mg dose lowered HbA1c more than 1.5 mg at 36 weeks (1.77 vs 1.54 points) with slightly more weight loss (4.6 vs 3.0 kg).

Risks and side effects

  • Nausea, diarrhea, vomiting and abdominal pain
  • Boxed warning: thyroid C-cell tumors in rats; contraindicated with a personal or family history of medullary thyroid cancer or MEN 2
  • Acute pancreatitis, gallbladder disease and acute kidney injury from dehydration
  • Hypoglycemia with insulin or insulin secretagogues; hypersensitivity reactions including anaphylaxis
  • Risk of pulmonary aspiration during general anesthesia or deep sedation

Label dosing

Label: in adults start at 0.75 mg once weekly, increase to 1.5 mg after 4 weeks and then in 1.5 mg steps at least 4 weeks apart as needed, up to 4.5 mg weekly.

Summarised from the official prescribing information. Not a recommendation: dosing is decided with a prescriber.

Regulatory status

RegionYearApproved for
USFDA2014Type 2 diabetes (children 10 and older from 2022); cardiovascular risk reduction added in 2020
EUEMA2014Type 2 diabetes in adults and children 10 and older

Status by country

JurisdictionStatusSource
USUnited StatesAuthorised medicineSource 1
EUEuropean UnionAuthorised medicineSource 6
UKUnited KingdomAuthorised medicineSource 7
AUAustraliaAuthorised medicineSource 8
CACanadaAuthorised medicineSource 9
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Dulaglutide to watch

  1. Phase 3Recruiting

    AWARD-PEDS PLUS(opens the source in a new tab)

    A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

    Primary completion expected December 202755 participantsSponsor: Eli Lilly and CompanyNCT06739122

All trials to watch

Timeline

  1. 2027

    1. AWARD-PEDS PLUS

  2. 2026

    1. ApprovalFDA approves Mounjaro to lower heart attack, stroke and CV death risk in type 2 diabetes
    2. RegulatoryEMA declines new heart-risk indication for Mounjaro but adds trial data to label
    3. SafetyUK regulator strengthens GLP-1 warnings on severe, necrotising and fatal pancreatitis

  3. 2025

    1. RegulatoryWHO adds semaglutide, tirzepatide and other GLP-1 drugs to its essential medicines list
    2. Trial resultSURPASS-CVOT: tirzepatide matches dulaglutide on heart outcomes in type 2 diabetes
    3. ResearchVeterans study maps GLP-1 drug benefits and risks across 175 health outcomes

  4. 2024

    1. SafetyEMA safety committee finds no causal link between GLP-1 drugs and suicidal thoughts

  5. 2014

    1. Approved, US (FDA)Type 2 diabetes (children 10 and older from 2022); cardiovascular risk reduction added in 2020
    2. Approved, EU (EMA)Type 2 diabetes in adults and children 10 and older

Sources

  1. 01Trulicity (dulaglutide) injection: prescribing information(opens the source in a new tab) DailyMed, U.S. National Library of Medicine, 2026
  2. 02Dulaglutide (D09889): sequence and structure entry(opens the source in a new tab) KEGG DRUG
  3. 03Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND)(opens the source in a new tab) The Lancet, 2019
  4. 04Efficacy 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)(opens the source in a new tab) Diabetes Care, 2021
  5. 05Engineering and characterization of the long-acting GLP-1 analogue LY2189265, an Fc fusion protein(opens the source in a new tab) Diabetes/Metabolism Research and Reviews, 2010
  6. 06Trulicity: EPAR (European public assessment report)(opens the source in a new tab) European Medicines Agency, 2026
  7. 07Trulicity 1.5 mg solution for injection in pre-filled pen: Summary of Product Characteristics(opens the source in a new tab) electronic medicines compendium (emc), 2026
  8. 08TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen (217965)(opens the source in a new tab) Therapeutic Goods Administration
  9. 09Drug Product Database: Trulicity (DIN 02448602)(opens the source in a new tab) Health Canada, 2026
  1. In clinical trialsAmycretinUnimolecular GLP-1 and amylin receptor agonistNo single sequence68 WADA banned
  2. Not approvedAOD-9604Modified growth hormone fragment (research peptide)16 WADA banned
  3. In clinical trialsCagrilintideLong-acting amylin analog (amylin and calcitonin receptor agonist)37 WADA banned
  4. ApprovedExenatideGLP-1 receptor agonist39
  5. ApprovedInsulin (human)Peptide hormone (insulin)51 WADA banned

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.