Dulaglutide

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 15 September 2026

Dulaglutide (Trulicity) is a major, real, FDA-approved once-weekly GLP-1 receptor agonist — approved for type 2 diabetes and, separately, for reducing cardiovascular events, with a real positive cardiovascular-outcomes trial behind that second approval.

In brief

Should you care? Relevant if you're comparing GLP-1 drugs for type 2 diabetes specifically — dulaglutide is not approved for weight loss/obesity the way semaglutide and tirzepatide are.

The short version

Approved 18 September 2014 for type 2 diabetes; a separate cardiovascular-risk-reduction indication followed on 21 February 2020.
REWIND trial: reduced major cardiovascular events (12.0% vs. 13.4%, HR 0.88) in a broad population — only about a third of whom had existing cardiovascular disease.
No significant reduction in all-cause mortality was shown — a real, honest limit on what the cardiovascular data actually proves.

What it is

Dulaglutide is a once-weekly GLP-1 receptor agonist from Eli Lilly, structurally a fusion of a modified GLP-1 peptide sequence to a human IgG4 Fc fragment (extending its half-life, similar in spirit to how romiplostim uses an Fc fusion, though for a different receptor). It is not approved for obesity or weight management in the US — any weight-loss use is off-label — which sets it apart from semaglutide and tirzepatide on this site.

The approvals and the REWIND trial

The FDA approved dulaglutide (as Trulicity) on 18 September 2014 for type 2 diabetes. A second, separate approval followed on 21 February 2020: reducing major adverse cardiovascular events (MACE) in adults with type 2 diabetes, with or without existing cardiovascular disease — the first GLP-1 drug approved for this broader population. That approval rested on the REWIND trial (Gerstein et al., Lancet 2019, PMID 31189511): 9,901 patients, median follow-up 5.4 years, notable for having the broadest primary-prevention population of any GLP-1 cardiovascular-outcomes trial (only about 31% had established cardiovascular disease at baseline). The composite outcome (nonfatal MI, nonfatal stroke, or cardiovascular death) occurred in 12.0% of the dulaglutide group versus 13.4% on placebo (HR 0.88, 95% CI 0.79-0.99, p=0.026) — a real, statistically significant reduction, though a modest one. Worth being precise here: all-cause mortality was not significantly reduced (HR 0.90, 95% CI 0.80-1.01, p=0.067) — the cardiovascular benefit shown is real but narrower than "reduces mortality."

Safety

Standard GLP-1-class warnings apply: a boxed warning for thyroid C-cell tumor risk (based on rodent studies; human relevance undetermined), contraindicated in patients with a personal or family history of medullary thyroid carcinoma or MEN2, and a labeled pancreatitis warning.

Current status

Still marketed and FDA-approved, though sales have declined sharply as Lilly's own tirzepatide (Mounjaro/Zepbound) has taken share — reported revenue fell from roughly $7.1 billion in 2023 to about $5.2 billion in 2024. No FDA warning letter names dulaglutide as a grey-market "research peptide" — its Fc-fusion structure makes it a poor compounding target, and it has no weight-loss indication to attract that market in the first place.

References

Gerstein HC, Colhoun HM, Dagenais GR, et al. (REWIND Investigators), "Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial," Lancet 2019;394(10193):121-130, PMID 31189511.
FDA approval history for Trulicity (dulaglutide): 18 September 2014 (type 2 diabetes); 21 February 2020 (cardiovascular risk reduction).