Dulaglutide: the basics
What is it?
A prescription medicine that copies GLP-1, a gut hormone that helps control blood sugar. It is attached to part of an antibody so one injection lasts a week.
Research paper 1 ↗Research paper 2 ↗What do people claim it helps with?
Better blood-sugar control in type 2 diabetes and a lower chance of heart attack or stroke in some people with type 2 diabetes. It is not approved as a weight-loss drug.
What has research actually shown?
Large trials found better blood-sugar control than placebo and an older GLP-1 drug. In REWIND, about 12 in 100 people on dulaglutide had a major heart event over five years, compared with about 13 in 100 on placebo.
Research paper 1 ↗Research paper 2 ↗Has this been demonstrated in people?
Demonstrated in people, including large controlled clinical trials in adults and a smaller trial in young people aged 10 to 17 with type 2 diabetes.
Research paper 1 ↗Research paper 2 ↗What side effects, risks and unknowns should I understand?
Nausea, diarrhea, vomiting, stomach pain and less appetite are common. Pancreatitis, low blood sugar when combined with insulin or sulfonylureas, kidney problems from dehydration and serious allergic reactions can happen. Rats developed thyroid tumors; whether this matters for people is unknown.
Prescribing information ↗Is it an approved medicine?
Yes. Trulicity is FDA-approved for type 2 diabetes in adults and children 10 and older, and to lower major heart-event risk in adults with type 2 diabetes and heart disease or risk factors.
FDA safety information 1 ↗Prescribing information 2 ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
Prescription once-weekly injection under the skin from a single-dose pen, prescribed after a doctor checks it suits you.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
Dulaglutide, semaglutide, liraglutide and tirzepatide are different medicines with different labels and trials. Results for one do not transfer to another.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Dulaglutide Evidence & Clinical Profile
Established Clinical Trials
Dulaglutide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Dulaglutide?
Dulaglutide (Trulicity) is Dulaglutide is a once-weekly GLP-1 receptor agonist made by joining a modified GLP-1 sequence to an antibody Fc fragment. Sold as Trulicity by Eli Lilly, it is FDA-approved to improve blood-sugar control in type 2 diabetes (adults and children 10 years and older) and to lower the risk of major cardiovascular events in adults with type 2 diabetes who have heart disease or several risk factors, based on the REWIND trial. Aliases include: Trulicity, LY2189265.
- Sequence (one-letter)
- Two identical disulfide-linked chains, each a GLP-1 analogue joined by a short peptide linker to a modified human IgG4 Fc fragment (per the U.S. label)
- Molecular formula
- N/A
- Molecular weight
- approximately 63 kDa (U.S. label)
- CAS Number
- 923950-08-7
- UNII Code
- WTT295HSY5
- PubChem CID
- N/A
Dulaglutide is an Fc-fusion protein, so it has no PubChem compound record; identifiers are from FDA GSRS.
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND) [1]
What was reported
First major cardiovascular event (non-fatal heart attack, non-fatal stroke or cardiovascular death): 594 (12.0%) with dulaglutide vs 663 (13.4%) with placebo; hazard ratio 0.88 (95% CI 0.79 to 0.99).
What limits the conclusion
The absolute difference was about 1.4 percentage points over more than five years. All-cause death did not differ significantly (HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were more common (47.4% vs 34.1%). Funded by Eli Lilly.
Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND trial [2]
What was reported
The composite kidney outcome occurred in 848 (17.1%) participants on dulaglutide vs 970 (19.6%) on placebo (HR 0.85).
What limits the conclusion
Exploratory, not a primary endpoint, and driven by a composite that included albuminuria. It does not establish dulaglutide as a kidney-disease treatment, and kidney outcomes are not an approved indication.
Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes (AWARD-1) [3]
What was reported
At 26 weeks, HbA1c fell by 1.51 and 1.30 percentage points with the two dulaglutide doses studied, vs 0.99 with exenatide and 0.46 with placebo; both dulaglutide arms were superior to placebo and exenatide.
What limits the conclusion
Industry-funded, surrogate endpoint (HbA1c) and a specific background therapy, so results may not generalize to other regimens. Nausea, vomiting and diarrhea were the most common adverse events.
Once-weekly dulaglutide for the treatment of youths with type 2 diabetes [4]
What was reported
At 26 weeks HbA1c rose 0.6 points with placebo and fell 0.6 and 0.9 points with the two dulaglutide doses; 51% vs 14% reached HbA1c below 7.0%.
What limits the conclusion
No difference in BMI change. Gastrointestinal adverse events were more frequent with dulaglutide. Short duration and modest size. Funded by Eli Lilly.
How the compound may work
Mechanisms describe how Dulaglutide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
GLP-1 receptor activation
Dulaglutide activates the GLP-1 receptor on pancreatic beta cells, raising cyclic AMP and increasing insulin release when glucose is high. It also lowers glucagon secretion and slows gastric emptying. [5]
Built for once-weekly use
The GLP-1 part is about 90% identical to native GLP-1 but modified to resist breakdown by the enzyme DPP-4. Fusing it to a modified IgG4 Fc fragment makes a large molecule (about 63 kDa) suited to once-weekly injection. [5]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Type 2 diabetes glucose control
Randomized trials compared dulaglutide with placebo and other glucose-lowering drugs in adults, and with placebo in youths aged 10 to 17. [3]
Cardiovascular risk in type 2 diabetes
A long placebo-controlled trial in people with type 2 diabetes with or without established cardiovascular disease; the basis of the cardiovascular-risk indication. [1]
Kidney markers
REWIND kidney analyses are hypothesis-generating; they are not an approved use. [2]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| REWIND: cardiovascular outcomes · 2019 [1] | Multicentre, randomized, double-blind, placebo-controlled trial; median follow-up 5.4 years n = 9901 |
Clinical endpoint evaluation | The absolute difference was about 1.4 percentage points over more than five years. All-cause death did not differ significantly (HR 0.90, 95% CI 0.80 to 1.01). Gastrointestinal adverse events were more common (47.4% vs 34.1%). Funded by Eli Lilly. |
| REWIND: exploratory kidney analysis · 2019 [2] | Exploratory analysis of the REWIND randomized trial n = 9901 |
Clinical endpoint evaluation | Exploratory, not a primary endpoint, and driven by a composite that included albuminuria. It does not establish dulaglutide as a kidney-disease treatment, and kidney outcomes are not an approved indication. |
| AWARD-1: vs exenatide and placebo · 2014 [3] | Randomized, multicenter, parallel-arm trial; placebo-controlled for 26 weeks, 52 weeks total n = 978 |
Clinical endpoint evaluation | Industry-funded, surrogate endpoint (HbA1c) and a specific background therapy, so results may not generalize to other regimens. Nausea, vomiting and diarrhea were the most common adverse events. |
| AWARD-PEDS: youths with type 2 diabetes · 2022 [4] | Double-blind, placebo-controlled randomized trial; 26 weeks plus 26-week open-label extension n = 154 |
Clinical endpoint evaluation | No difference in BMI change. Gastrointestinal adverse events were more frequent with dulaglutide. Short duration and modest size. Funded by Eli Lilly. |
Regulatory Status & Clinical Safety
Regulatory Classification
United States, checked 11 October 2026: Trulicity (BLA 125469, Eli Lilly) is approved as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. It carries a boxed warning about thyroid C-cell tumors seen in rats; human relevance is unknown. It is not approved for weight management or for type 1 diabetes. GLP-1 receptor agonists are not named on the WADA Prohibited List; check the current list before competition.
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) [9]
- Planned enrollment
- 9901 (actual enrollment)
- Posted results
- Available
- Sponsor
- Eli Lilly and Company
- Last updated
- 2019-10-08
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-1) [10]
- Planned enrollment
- 978 (actual enrollment)
- Posted results
- Available
- Sponsor
- Eli Lilly and Company
- Last updated
- 2015-01-26
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes [11]
- Planned enrollment
- 154 (actual enrollment)
- Posted results
- Available
- Sponsor
- Eli Lilly and Company
- Last updated
- 2022-07-01
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Dulaglutide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
-
2014
FDA approval
FDA approves Trulicity (BLA 125469) for glycemic control in adults with type 2 diabetes. [6]
-
2019
REWIND published
The cardiovascular outcomes trial reports a reduction in first major cardiovascular events versus placebo. [1]
-
2020
Cardiovascular indication
FDA approves a supplement adding the indication to reduce major adverse cardiovascular events, based on REWIND. [7]
-
2022
Pediatric indication
FDA extends the glycemic-control indication to patients 10 years and older, based on AWARD-PEDS. [8]
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
- Cardiovascular outcomes RCT DOI: 10.1016/S0140-6736(19)31149-3 ↗ (external website)
- Exploratory trial analysis DOI: 10.1016/S0140-6736(19)31150-X ↗ (external website)
- Phase 3 RCT DOI: 10.2337/dc13-2760 ↗ (external website)
-
Phase 3 RCT
Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes ↗ (external website)
DOI: 10.1056/NEJMoa2204601 ↗ (external website) -
Official prescribing information
Trulicity (dulaglutide) injection, current U.S. label ↗ (external website)
Eli Lilly SPL published August 2026; checked 11 October 2026.
-
FDA approval record
Drugs@FDA: Trulicity, BLA 125469 ↗ (external website)
Original approval 18 September 2014.
- FDA supplement approval letter
- FDA supplement approval letter
-
Official registry
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) ↗ (external website)
API record checked 11 October 2026.
-
Official registry
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-1) ↗ (external website)
API record checked 11 October 2026.
-
Official registry
API record checked 11 October 2026.