FDA-approved medicines exist for specific indications

Dulaglutide

Once-weekly GLP-1 receptor agonist (Trulicity-class) — labeled for type 2 diabetes including CV-risk framing.

Editorial review:

What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. Dulaglutide is a once-weekly injectable GLP-1 receptor agonist fusion protein (developmental code LY2189265; US product name Trulicity). Substance-level identity: CAS 923950-08-7; UNII WTT295HSY5. As a large fusion protein it often lacks a clean small-molecule PubChem compound CID — this drawer badges CAS / UNII / Trulicity name, and does not invent a peptide CID. Approved-indication papers below are about specific labeled product–use pairs (Trulicity-class dulaglutide for type 2 diabetes objects, including cardiovascular-outcomes framing in REWIND). They do not travel to semaglutide, tirzepatide, liraglutide, retatrutide, mazdutide, survodutide, an unlabeled use, or a vial that is not the trial product. Weight change in T2D trials is not the same object as a Saxenda/Wegovy-class chronic-weight label.

Bottom line

Dulaglutide has large, labeled human programs for type 2 diabetes (AWARD glycemic set; REWIND cardiovascular and exploratory renal analyses). Comparator papers (SUSTAIN 7 vs semaglutide; SURPASS-CVOT vs tirzepatide) test other products against dulaglutide; they are not dulaglutide monotherapy label expansions. Mark which object each paper tests.

Papers

Approved indication — type 2 diabetes (AWARD / Trulicity-class object)

PMID 24879836 — Wysham 2014 (AWARD-1)

Tested: once-weekly injectable dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes (AWARD-1).

Does not show: a chronic-weight obesity-without-diabetes label, or that every GLP-1 agonist is interchangeable.

PMID 26089386 — Giorgino 2015 (AWARD-2)

Tested: once-weekly injectable dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2).

Does not show: an obesity-without-diabetes claim, or a cardiovascular-outcomes claim (that is REWIND).

PMID 24842985 — Umpierrez 2014 (AWARD-3)

Tested: once-weekly injectable dulaglutide monotherapy versus metformin in type 2 diabetes (AWARD-3).

Does not show: add-on therapy results from other AWARD arms as if they were monotherapy, or a weight-management label.

PMID 24742660 — Nauck 2014 (AWARD-5)

Tested: once-weekly injectable dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes (AWARD-5).

Does not show: a REWIND cardiovascular claim, or interchangeability with DPP-4 inhibitors as a class copy.

PMID 25018121 — Dungan 2014 (AWARD-6)

Tested: once-weekly injectable dulaglutide versus once-daily liraglutide in metformin-treated type 2 diabetes (AWARD-6; non-inferiority design).

Does not show: that dulaglutide equals liraglutide for every use, or a Saxenda-class weight claim for either product.

Approved indication — cardiovascular (and exploratory renal) outcomes in T2D (REWIND)

PMID 31189511 — Gerstein 2019 (REWIND)

Tested: once-weekly injectable dulaglutide versus placebo for major adverse cardiovascular outcomes in type 2 diabetes (REWIND).

Does not show: a cardiovascular claim in people without type 2 diabetes, or an obesity-without-diabetes SELECT-style object.

PMID 31189509 — Gerstein 2019 (REWIND renal exploratory)

Tested: exploratory renal outcomes with dulaglutide versus placebo inside the REWIND type 2 diabetes cardiovascular-outcomes trial.

Does not show: a standalone dedicated renal-outcomes indication separate from the REWIND object, or renal results outside this enrollment.

Comparator papers (dulaglutide is the reference arm — not a dulaglutide monotherapy label expansion)

PMID 29397376 — Pratley 2018 (SUSTAIN 7)

Tested: once-weekly injectable semaglutide versus once-weekly injectable dulaglutide for glycemic control in type 2 diabetes (SUSTAIN 7).

Does not show: that semaglutide and dulaglutide are the same object, or a dulaglutide obesity label.

PMID 41406444 — Nicholls 2025 (SURPASS-CVOT)

Tested: tirzepatide versus dulaglutide for major adverse cardiovascular events in type 2 diabetes (SURPASS-CVOT).

Does not show: a placebo-controlled dulaglutide CV claim (that remains REWIND), or that tirzepatide and dulaglutide are interchangeable for every use.

What is not established

A US chronic weight-management indication analogous to Saxenda/Wegovy as the primary labeled object on this page. That AWARD glycemic papers settle REWIND cardiovascular questions or the reverse. Interchangeability with semaglutide, tirzepatide, liraglutide, or investigational dual/triple agonists. A non-trial preparation is not the Trulicity-class AWARD/REWIND material.

Selected sources

24879836 26089386 24842985 24742660 25018121 31189511 31189509 29397376 41406444

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