FDA ReviewedUpdated June 23, 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 (not clinically reviewed) · 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.

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
Alaska Medicaid GLP-1 Coverage 2026: PA Pathway, Eligibility & Appeals
Alaska Medicaid does NOT cover Wegovy, Zepbound, or Saxenda for chronic weight management in 2026. Pattern #49 is exclusion-by-absence: the Alaska Medicaid Preferred Drug List effective March 1, 2026 (42 pages, posted January 23, 2026) lists OZEMPIC, RYBELSUS, MOUNJARO.
18 min read23 citations
Hawaii Medicaid GLP-1 Coverage 2026: PA Pathway, Eligibility & Appeals
Hawaii Med-QUEST does NOT cover GLP-1 receptor agonists for chronic weight management in 2026 — and Pattern #50 is THE CAPSTONE article completing the WLR 50-state Medicaid GLP-1 coverage series. AlohaCare QUEST Formulary verbatim: 'Drugs for weight loss, erectile dysfunction.
22 min read31 citations
Ohio Medicaid GLP-1 Coverage (2026): Triple-Anchored Weight-Loss Exclusion + the January 2026 Wegovy MACE/MASH Carve-Back-In
Ohio Medicaid (ODM / Gainwell SPBM) is the MOST EXPLICITLY ANCHORED non-coverage state in our 50-state Medicaid GLP-1 series: TRIPLE-ANCHORED by federal statute (42 U.S.C. § 1396r-8(d)(2)(A)), Ohio Administrative Code 5160-9-03(B)(1) state regulation ('Drugs for the treatment of obesity' expressly non-covered), and a real-time Gainwell SPBM claim-adjudication gate (November 7, 2025 notice, effective December 8, 2025: 'For all other non-FDA approved uses (such as prediabetes or weight loss), coverage will not be available'). OAC 5160-9-03(D) also explicitly forecloses prior authorization as a route around the exclusion — drugs on the non-covered list 'are not eligible for prior authorization.' The January 7, 2026 Ohio Medicaid P&T Committee created a NEW drug class — 'Metabolic Modifiers: GLP-1 Agonists for Non-Obesity Indications' — and approved Wegovy as Preferred, Clinical PA Required for FDA MACE (cardiovascular event reduction) and noncirrhotic MASH indications. The Wegovy MACE criteria are BROADER than New York's on BMI (Ohio: BMI ≥ 27 matching the FDA label; NY: BMI ≥ 40) but STRICTER than the FDA MACE label on diabetes: Ohio explicitly excludes any patient with type 1 or type 2 diabetes (A1C must be < 6.5%). Ohio's Wegovy carve-back-in is BROADER than California's April 2026 MASH-only addition — Ohio covers both MACE and MASH. Wegovy for chronic weight management remains NOT COVERED. Zepbound, Saxenda, and Foundayo are NOT listed anywhere in the Ohio UPDL. The Jan 7, 2026 UPDL: Byetta/exenatide/Trulicity/Victoza (BvG) Preferred for T2D; Bydureon BCise/liraglutide/Mounjaro/Ozempic/Rybelsus/Soliqua/Xultophy Non-Preferred for T2D. Ohio is not among the 13 states KFF (January 2026) identifies as covering GLP-1s for obesity under fee-for-service. Ohio HB 388 (Williams/Jarrells, 136th GA) targets state-employee benefits via DAS, NOT Medicaid. The Gainwell SPBM consolidates all managed-care and FFS pharmacy under one UPDL — plan-level divergence across CareSource, Buckeye Health Plan, AmeriHealth Caritas Ohio, Molina, Anthem BCBS Ohio, Humana is structurally impossible. The fifth installment in our 50-state Medicaid GLP-1 series after Texas, California, New York, and Florida.
18 min read9 citations
Florida Medicaid GLP-1 Coverage 2026: PA Pathway, Eligibility & Appeals
Florida Medicaid covers GLP-1 receptor agonists ONLY for type 2 diabetes mellitus — Mounjaro, Ozempic, and Trulicity are Preferred on the April 1, 2026 AHCA PDL with Clinical PA (HbA1c ≥ 6.5%, metformin trial-and-failure). Florida does NOT cover Wegovy, Zepbound, or Saxenda for.
16 min read7 citations
California Medi-Cal GLP-1 Coverage (2026): The State Reversal That Removed Wegovy + Zepbound for Weight Loss
California REVERSED COURSE on GLP-1 obesity coverage effective January 1, 2026 — the enacted 2025-26 State Budget directed the Department of Health Care Services (DHCS) to remove Wegovy, Zepbound, and Saxenda from the Medi-Cal Rx Contract Drugs List (CDL) for weight-loss and weight-loss-related indications. All previously approved PAs expired December 31, 2025; claims now deny with Reject Code 70 (Wegovy/Zepbound/Saxenda for weight loss). Wegovy was added back to the CDL effective April 1, 2026 — but ONLY for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH); claims must be submitted with ICD-10-CM diagnosis code K76.0 or K75.8 or they deny with Reject Code 80. Zepbound for obstructive sleep apnea (OSA) and Wegovy for cardiovascular disease are PA-reviewable on a case-by-case basis only. Ozempic, Rybelsus, Mounjaro, Victoza, Byetta, Bydureon, and Trulicity remain on the CDL with a Code I diagnosis restriction of type 2 diabetes — no PA required for the T2D indication when an appropriate ICD-10-CM diagnosis code is on the pharmacy claim. California's outpatient pharmacy benefit was carved out of managed care into the statewide Medi-Cal Rx fee-for-service program on January 1, 2022 — so plan-level divergence (LA Care, Health Net, IEHP, Kaiser Permanente Medi-Cal, Molina, Anthem Blue Cross Medi-Cal, Blue Shield Promise) is structurally impossible. SB 535 is still pending in Assembly Appropriations and would NOT have changed Medi-Cal coverage even if signed; AB 575 died January 31, 2026. Per the KFF January 2026 tracker, California is one of four states (with New Hampshire, Pennsylvania, and South Carolina) that eliminated Medicaid GLP-1 coverage for obesity treatment after the October 2025 KFF survey. The legal authority is the federal optional weight-loss-drug exclusion at 42 U.S.C. § 1396r-8(d)(2)(A). Members denied a GLP-1 PA may request a State Hearing within 90 days of the Notice of Action; members already taking a GLP-1 on or before January 1, 2026 may continue to receive the drug pending the State Hearing decision if they request the hearing within 10 days of the NOA.
16 min read6 citations

Frequently Asked Questions

Sources & methodology — as of June 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.