FDA-Approved MedicationUpdated August 7, 2026

Trulicity Guide

Trulicity is the brand-name formulation of dulaglutide, a once-weekly subcutaneous GLP-1 receptor agonist FDA-approved for glycemic control in adults with type 2 diabetes and for cardiovascular risk reduction in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. Manufactured by Eli Lilly, Trulicity was the first GLP-1 to show a CV benefit in a primary-prevention diabetes population (REWIND, 2019). It has never had an obesity indication — average weight loss in trials is modest at roughly 3–5 kg — and Wegovy and Zepbound dominate the chronic weight management category.

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By Eli Marsden · Founding Editor
Editorially reviewed & fact-checked against primary sources · How we verify contentLast reviewed

At a Glance

Generic NameDulaglutide
Brand NamesTrulicity
FDA StatusFDA-approved for glycemic control in adults with type 2 diabetes mellitus (September 18, 2014); FDA-approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established CVD or multiple cardiovascular risk factors (February 2020); pediatric indication for type 2 diabetes in patients aged 10 years and older added in 2022. Not approved for chronic weight management.[1]
Approval DateSeptember 18, 2014[1]

How Trulicity Works

Dulaglutide is a long-acting GLP-1 receptor agonist engineered by fusing two modified GLP-1 peptide chains to a human IgG4 Fc fragment, which extends the half-life to about five days and allows once-weekly dosing. By activating GLP-1 receptors, dulaglutide stimulates glucose-dependent insulin secretion, suppresses inappropriate glucagon release, slows gastric emptying, and modestly reduces appetite. The blood-sugar-lowering effect is the labeled indication; the weight reduction is a secondary effect that is smaller than what is seen with semaglutide or tirzepatide.[2]

Dosing Schedule

Trulicity uses a gradual dose escalation to minimize side effects. Always follow your prescriber's guidance and the current FDA label[1].

Weeks 1–40.75 mg/week (starting dose)
Week 5+1.5 mg/week (standard maintenance)
After ≥4 weeks at 1.5 mg3 mg/week (if additional glycemic control needed)
After ≥4 weeks at 3 mg4.5 mg/week (maximum recommended dose)

Side Effects

Common: nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia, fatigue. Side effects are most pronounced during dose initiation and escalation, and typically diminish over 4–8 weeks. Serious (rare): pancreatitis, gallbladder disease (cholecystitis, cholelithiasis), acute kidney injury (often secondary to dehydration from GI side effects), severe hypoglycemia when combined with insulin or sulfonylureas, hypersensitivity reactions, diabetic retinopathy complications. Boxed warning for thyroid C-cell tumors observed in rodents; contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).[1][2]

This is not a complete list. Consult your healthcare provider or prescriber for full safety information. The complete adverse reaction profile is published in the current FDA prescribing information[1].

Clinical Trial Results

The AWARD program comprised the pivotal phase 3 trials supporting Trulicity's approval and label expansions, evaluating dulaglutide as monotherapy and in combination with metformin, sulfonylureas, insulin, and SGLT2 inhibitors across more than 10 studies. AWARD-7 (Tuttle et al. Lancet Diabetes Endocrinol 2018, PMID 29910024) showed dulaglutide was noninferior to insulin glargine for HbA1c reduction in patients with type 2 diabetes and moderate-to-severe chronic kidney disease, with less weight gain and a lower hypoglycemia rate. SUSTAIN-7 (Pratley et al. Lancet Diabetes Endocrinol 2018, PMID 29397376) directly compared once-weekly semaglutide to dulaglutide; semaglutide produced greater reductions in HbA1c and body weight at matched dose levels. The landmark REWIND cardiovascular outcomes trial (Gerstein et al. Lancet 2019, PMID 31189511) randomized 9,901 adults with type 2 diabetes — most without established CVD — and showed a 12% relative reduction in major adverse cardiovascular events with dulaglutide 1.5 mg over a median follow-up of 5.4 years (HR 0.88, 95% CI 0.79–0.99). REWIND remains the largest and longest GLP-1 CVOT and the first to demonstrate CV benefit in a primary-prevention diabetes population, though the effect size was the smallest in the GLP-1 CVOT class.[2]

Source: Published clinical trial data (STEP / SURMOUNT trial series) — see the Sources panel below for full citations.

Where to Get Trulicity

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Short-form verdict pages comparing Trulicity to other GLP-1 options with trial-anchored data, FDA-label dosing, and current manufacturer pricing.

See all drug-vs-drug verdicts.

Endpoint-by-endpoint breakdowns of the trials that shaped the Trulicity label, with primary-source numbers and FAQs.

REWIND
REWIND is the largest and longest GLP-1 cardiovascular outcomes trial ever conducted — 9,901 adults with type 2 diabetes followed a median 5.4 years, with the unique distinction that 69% had no established cardiovascular disease at baseline. Weekly dulaglutide 1.5 mg reduced the primary three-point MACE composite by 12% versus placebo (HR 0.88, 95% CI 0.79-0.99, P=0.026). Unlike LEADER and SUSTAIN-6, which enrolled mostly secondary-prevention populations, REWIND tested whether GLP-1 agonism could prevent first cardiovascular events in lower-risk T2D patients — and the answer was yes, with effect sizes that held up in both primary- and secondary-prevention subgroups.
Phase 3 · N=9,901 · Last verified 2026-05-28
AWARD-7
AWARD-7 is the first phase-3 GLP-1 receptor agonist trial designed specifically for adults with type 2 diabetes and moderate-to-severe chronic kidney disease (eGFR 15 to <60 mL/min/1.73 m²). Eli Lilly randomized 577 participants to once-weekly dulaglutide 1.5 mg, dulaglutide 0.75 mg, or daily insulin glargine titrated to fasting plasma glucose, all layered on prandial insulin lispro, for 52 weeks. Both dulaglutide doses met non-inferiority versus glargine on the HbA1c primary endpoint at 26 weeks and produced less eGFR decline, lower urinary albumin-to-creatinine ratio, weight loss (rather than weight gain), and roughly two-thirds fewer hypoglycemic events at week 52. The trial supplied the kidney-specific evidence base behind dulaglutide's label use in advanced CKD and seeded later kidney-outcome programs.
Phase 3 · N=577 · Last verified 2026-05-28
SUSTAIN-7
SUSTAIN-7 (Pratley 2018 Lancet Diabetes Endocrinol, PMID 29397376) is the first registrational head-to-head trial of two once-weekly GLP-1 receptor agonists. Novo Nordisk randomized 1,201 adults with type 2 diabetes inadequately controlled on metformin 1:1:1:1 to once-weekly subcutaneous semaglutide 0.5 mg, dulaglutide 0.75 mg, semaglutide 1.0 mg, or dulaglutide 1.5 mg for 40 weeks in an open-label design. At both the low-dose and high-dose comparisons, semaglutide cut HbA1c roughly 0.4 percentage points more than dulaglutide and reduced body weight by an additional 2.3 to 3.5 kg, with broadly similar gastrointestinal tolerability. The trial provided the regulatory and clinical basis for positioning semaglutide as the strongest A1C-reducing GLP-1 in the class.
Phase 3b · N=1,201 · Last verified 2026-05-28

Curated lists of the highest-impact peer-reviewed studies on Trulicity and related GLP-1 drugs. Every PMID live-verified via PubMed esummary.

Deep-dive articles from our research desk with primary-source trial data, FDA label verification, and editorial analysis.

Retatrutide for type 2 diabetes: Phase 2 evidence and what TRIUMPH-2 is testing
Retatrutide is investigational only as of August 2026 — not FDA-approved for T2D anywhere. The Phase 2 T2D trial (Rosenstock 2023, n=281) produced HbA1c reductions up to -2.02% at 12 mg vs -1.41% dulaglutide. TRIUMPH-2 Phase 3 completed in June 2026; results not yet published.
18 min read10 citations
GLP-1 with Kidney Disease (CKD): The Patient Action Plan
If you have CKD and your clinician is considering a GLP-1, here is what changed: FLOW trial Perkovic 2024 NEJM 24% kidney + CV event reduction, AWARD-7 dulaglutide in moderate-severe CKD, no renal dose adjustment for most GLP-1s, sick-day rules with SGLT2 + ACE-I.
14 min read10 citations
GLP-1s for Alzheimer's & Dementia Prevention: Patient Guide
Is Ozempic protective against Alzheimer's? Patient guide to the GLP-1 dementia evidence — ELAD liraglutide phase 2b, evoke/evoke+ semaglutide phase 3 negative topline (Nov 2025), Wang TTE 40-70% lower hazard, REWIND dulaglutide cognitive signal, APOE-e4 interactions, when to discuss…
12 min read11 citations
Mounjaro vs Trulicity: Glycemic Control and Switching Evidence
Tirzepatide vs dulaglutide: indirect comparison through SURPASS-2 and AWARD-11 shows ~0.5 pp larger A1C drop and 6 to 7 kg more weight loss on Mounjaro. Trulicity has REWIND MACE indication.
9 min read10 citations
Trulicity vs Ozempic vs Mounjaro for T2D: Head-to-Head Evidence
Trulicity (dulaglutide), Ozempic (semaglutide), and Mounjaro (tirzepatide) are the three injectable GLP-1 / GIP-GLP-1 options for T2D. We walk through SUSTAIN-7, SURPASS-2, AWARD-11, and the practical prescribing differences.
11 min read9 citations
SURPASS-CVOT: Tirzepatide Cardiovascular Outcomes (2026)
SURPASS-CVOT (NEJM 2025) tested tirzepatide vs dulaglutide in 13,299 adults with type 2 diabetes and heart disease: MACE 12.2% vs 13.1%, HR 0.92 — non-inferior.
13 min read6 citations

Frequently Asked Questions

Sources & methodology — as of August 2026
  1. 1.FDA — Wegovy (semaglutide) Approval History via Drugs@FDAU.S. Food & Drug Administration.
  2. 2.STEP 1 Trial — Once-Weekly Semaglutide in Adults with Overweight or Obesity (Wilding JPH et al.)New England Journal of Medicine.PMID: 33567185.
  3. 3.FDA — Compounding and the 503A Pharmacy FrameworkU.S. Food & Drug Administration.
  4. 4.FDA — Drug Shortages Database (current shortage listings)U.S. Food & Drug Administration.
  5. 5.IRS Publication 502 — Medical and Dental Expenses (HSA/FSA eligibility)Internal Revenue Service.