Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

title: "Dulaglutide: What the evidence says" slug: dulaglutide status: Draft (v1), pending review by Dr. Nova Reyes (Batch F #62) last_checked: 2026-10-25 evidence_verdict: "Type 2 diabetes and CV risk reduction (labeled): Strong · Gray-market/compounded: No human data" card_verdict: "Strong (type 2 diabetes, heart-risk reduction) · Gray-market/compounded: No human data" related: [liraglutide, semaglutide, exenatide]

Draft (v1), pending review. Not public. · ← Library · DRAFT · not published · last checked 2026-10-25

Dulaglutide: what the evidence says

At a glance

What it is: a GLP-1 receptor agonist fused to an antibody fragment (Fc) so it lasts a week, sold as Trulicity for type 2 diabetes and to lower cardiovascular risk. ^{R1, R2} It is a large biologic (approved under a BLA), not a short peptide.

What the evidence says: it lowers blood sugar more than placebo and more than twice-a-day exenatide (AWARD-1, 976 patients). ^R3 In REWIND (9,901 people, median 5.4 years) it reduced heart attacks, strokes and cardiovascular deaths (HR 0.88). ^R4

Biggest risks: boxed warning for thyroid C-cell tumors in rats; contraindicated with personal or family history of medullary thyroid cancer or MEN 2. ^R1 GI side effects were reported by 47% vs 34% on placebo in REWIND. ^R4

Rating


Human Human evidence	Strong for type 2 diabetes and cardiovascular risk reduction ^{R3, R4}; No human data on gray-market or compounded products
Animal Animal / lab evidence	Rat thyroid C-cell tumors (label) ^R1
Regulatory	FDA-approved: Trulicity BLA 125469 (Sep 18, 2014) ^R2 · boxed warning ^R1 · WADA: not named on the 2026 List ^R5
Established human dose	For labeled use: on the FDA label ^R1. Study details lists what trials used

Evidence verdict: Type 2 diabetes and CV risk reduction (labeled): Strong · Gray-market/compounded: No human data Card verdict: Strong (type 2 diabetes, heart-risk reduction) · Gray-market/compounded: No human data Card note: Not approved for weight loss; gray-market products are not Trulicity, see page.

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: both trials were funded by the manufacturer, Eli Lilly and Company. ^{R3, R4}

What is it?

Dulaglutide activates the GLP-1 receptor (more insulin when glucose is high, less glucagon, slower stomach emptying) and is injected once a week. ^R1 Because it is a large (~63 kDa) recombinant Fc-fusion glycoprotein produced in mammalian cell culture rather than a short solid-phase synthetic peptide, manufacturing it requires biologic cell-line expression and purification. ^R1 Related pages: Liraglutide, Semaglutide, Exenatide.

Does it work?

Human AWARD-1: on metformin plus pioglitazone, HbA1c fell 1.51 points on the higher amount vs 0.99 on exenatide and 0.46 on placebo at 26 weeks. ^R3
Human REWIND: 9,901 people, mostly without prior heart disease: events 12.0% vs 13.4% (HR 0.88, 95% CI 0.79–0.99); all-cause death not significantly different (HR 0.90). ^R4

Is it safe?

Human Boxed warning: thyroid C-cell tumors in rats; unknown in humans. ^R1
Human Label warnings include pancreatitis, low blood sugar with insulin or sulfonylureas, kidney injury from dehydration, severe gastrointestinal disease, diabetic retinopathy complications, and acute gallbladder disease. ^R1
Human REWIND: GI events 47.4% vs 34.1%. ^R4

Gray-market "research use only" Dulaglutide: extra risks

Not the approved product. Products sold as "research dulaglutide" are not Trulicity; identity, strength and sterility are unknown. Unknown Whether real dulaglutide (an Fc-fusion protein) is actually being sold on the gray market has not been checked.

What we don't know

Unknown Whether gray-market "dulaglutide" contains the actual fusion protein
Unknown Weight effects in people without diabetes (not an approved use)

Is it legal?

US: FDA-approved as Trulicity (BLA 125469) for type 2 diabetes in adults and children 10 and older, and to reduce major cardiovascular events in adults with type 2 diabetes. ^{R1, R2} Not approved for weight loss. EU, UK and others: UNVERIFIED. WADA: not named on the 2026 Prohibited List. ^R5

Study details

These are amounts researchers used, not recommendations. ### R3 Human RCT: AWARD-1 (Wysham 2014) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Wysham 2014 | 976 randomized adults with type 2 diabetes on metformin + pioglitazone | Subcutaneous | 0.75 or 1.5 mg once weekly (vs exenatide 10 mcg twice daily, placebo) | 52 weeks (primary 26) | HbA1c −1.51 / −1.30 vs −0.99 (exenatide), −0.46 (placebo) | Nausea, vomiting, diarrhea | [PMID 24879836](https://pubmed.ncbi.nlm.nih.gov/24879836/) | ### R4 Human RCT: REWIND (Gerstein 2019) | Study | People / model | Route | Amount used | Follow-up | Reported | Side effects / limitations | Citation | |---|---|---|---|---|---|---|---| | Gerstein 2019 | 9,901 adults with type 2 diabetes | Subcutaneous | 1.5 mg once weekly | Median 5.4 years | MACE HR 0.88 | GI events 47% vs 34%; Lilly-funded | [PMID 31189511](https://pubmed.ncbi.nlm.nih.gov/31189511/) · [NCT01394952](https://clinicaltrials.gov/study/NCT01394952) |

Full reference list (PubMed, ClinicalTrials.gov, openFDA and DailyMed entries checked Oct 25, 2026)

^R1 DailyMed. TRULICITY (dulaglutide) injection label, Eli Lilly, effective Jun 16, 2026. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309
^R2 FDA. Drugs@FDA data (openFDA drugsfda), BLA 125469 (Trulicity), original approval 2014-09-18, checked Oct 25, 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:dulaglutide
^R3 Wysham C, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014. PMID 24879836
^R4 Gerstein HC, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019. PMID 31189511
^R5 WADA. The 2026 Prohibited List (in force 1 January 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Dulaglutide. Talk to a clinician you trust before using any drug, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).

Approved for Adam Greene by Dr. Nova Reyes, 2026-10-25.