Dulaglutide

TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells.

• TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.ICD-10: E11.9, I21.9, I63.9

• TRULICITY is contraindicated in patients with: Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Serious hypersensitivity reaction to dulaglutide or to any of the product components.contraindicated

Adult Dosage ( 2.1 ) Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. Increase dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase dosage in 1.5 mg increments after at least 4 weeks on the current dosage. Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly. Pediatric Dosage ( 2.2 ) Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. If additional glycemic control is needed, increase dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage. Recommendations Regarding Missed Dose ( 2.3 ) If a dose is missed, administer the missed dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. Important Administration Instructions ( 2.4 ) Administer once weekly at any time of day with or without food. Inject subcutaneously in the abdomen, thigh, or upper arm. 2.1 Adult Dosage The recommended starting dosage of TRULICITY is 0.75 mg injected subcutaneously once weekly. Increase the dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage. The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly. 2.2 Pediatric Dosage The recommended starting dosage of TRULICITY is 0.75 mg injected subcutaneously once weekly.

Thyroid C-cell Tumors: See Boxed Warning ( 5.1 ). Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed ( 5.2 ). Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary ( 5.3 ). Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue TRULICITY and promptly seek medical advice ( 5.4 ). Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions ( 5.5 ). Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients ( 5.6 ). Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy ( 5.7 ). Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated ( 5.8 ). 5.1 Risk of Thyroid C-cell Tumors In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology ( 13.1 )] .

The following serious reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk to fetus ( 8.1 ). 8.1 Pregnancy Risk Summary Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see Data] .

Metabolism

The pharmacokinetics of dulaglutide is similar between healthy subjects and patients with type 2 diabetes mellitus. Following subcutaneous administration, the time to maximum plasma concentration of dulaglutide at steady state ranges from 24 to 72 hours, with a median of 48 hours.

Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (e.g., nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient's clinical signs and symptoms.

• Sep 18, 2014BLABLA125469Eli Lilly And Co

1. 1Nausea10,19912%
2. 2Injection Site Pain9,87211%
3. 3Blood Glucose Increased9,83111%
4. 4Diarrhoea5,9486.9%
5. 5Vomiting5,6086.5%
6. 6Incorrect Dose Administered5,5356.4%
7. 7Inappropriate Schedule Of Product Administration3,8314.4%
8. 8Drug Ineffective3,6024.2%
9. 9Weight Decreased3,3903.9%
10. 10Decreased Appetite3,2273.7%
11. 11Injection Site Haemorrhage3,1453.6%
12. 12Extra Dose Administered3,1403.6%
13. 13Glycosylated Haemoglobin Increased2,9323.4%
14. 14Fatigue2,4412.8%
15. 15Abdominal Pain Upper2,4282.8%

The 10 most recently updated of 136 ClinicalTrials.gov registrations naming Dulaglutide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
  Active not recruiting · Observational · 300,000 enrolled · Brigham and Women's Hospital
  NCT07417631updated 2026-06-11
• Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
  Active not recruiting · Observational · 120,000 enrolled · Brigham and Women's Hospital
  NCT07619495updated 2026-06-09
• Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
  Enrolling by invitation · Phase 1 · Phase 2 · Interventional · 50 enrolled · Ain Shams University
  NCT07319286updated 2026-06-05
• GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
  Recruiting · Phase 2 · Interventional · 30 enrolled · University of Pennsylvania
  NCT04731272updated 2026-05-18
• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
  Active not recruiting · Observational · 781,430 enrolled · Brigham and Women's Hospital
  NCT05220917updated 2026-05-15
• Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
  Completed · Observational · 70,000 enrolled · Brigham and Women's Hospital
  NCT06779929updated 2026-05-15
• INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
  Active not recruiting · Observational · 60,000 enrolled · Brigham and Women's Hospital
  NCT07417618updated 2026-05-13
• A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
  Recruiting · Phase 3 · Interventional · 55 enrolled · Eli Lilly and Company
  NCT06739122updated 2026-05-12
• GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery
  Recruiting · Phase 4 · Interventional · 372 enrolled · The University of Hong Kong
  NCT06324461updated 2026-05-04
• Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
  Not yet recruiting · Phase 4 · Interventional · 468 enrolled · First Affiliated Hospital of Wannan Medical College
  NCT07537088updated 2026-04-22

Frequently asked questions

How does Dulaglutide work?

TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells.

What is Dulaglutide used for?

According to FDA labeling, Dulaglutide carries indications including: TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dulaglutide?

Dulaglutide is classified as Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 Receptor Agonist, Glucagon-like Peptide-1 (GLP-1) Agonists, Decreased Gastric Motility, Decreased Glucagon Secretion.

What are the brand names for Dulaglutide?

Dulaglutide is marketed under brand names including Trulicity.

What are the contraindications for Dulaglutide?

Dulaglutide labeling lists contraindications including: TRULICITY is contraindicated in patients with: Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Serious hypersensitivity reaction to dulaglutide or to any of the product components.. Always consult the full prescribing information and a clinician.