Dulaglutide

Also known as: Trulicity

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application
Randomized controlled trials 147 of 1,332 publications on PubMed
Registered clinical trials 143 24 active
Adverse event reports 88,461 23,096 classified as serious
  • Dulaglutide is an FDA-approved drug, marketed as Trulicity (first approval: September 18, 2014).
  • PubMed lists 1,332 publications mentioning it, including 147 randomized controlled trials and 49 animal-only studies.
  • ClinicalTrials.gov lists 143 registered studies testing it (24 active).
  • FDA's adverse event system (FAERS) holds 88,461 reports mentioning it; 23,096 classified as serious. Reports do not prove causation.

Research topics

  • Glucagon-Like Peptides 87
  • Hypoglycemic Agents 87
  • Glucagon-Like Peptide-1 Receptor Agonists 75
  • Diabetes Mellitus, Type 2 73
  • Semaglutide 73
  • Immunoglobulin Fc Fragments 71
  • Recombinant Fusion Proteins 71
  • Tirzepatide 44
  • Liraglutide 33
  • Exenatide 25

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
BLA125469 TRULICITY Approved, marketed September 18, 2014 ELI LILLY AND CO

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 1,332
  • Human (MeSH) 841
  • Animal only 49
  • Clinical trials 158
  • Randomized controlled trials 147
  • Systematic reviews & meta-analyses 141
  • Case reports 70
  • Retracted 2

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
143
Active
24
With posted results
61

Conditions studied

  • Diabetes Mellitus, Type 2 43
  • Type 2 Diabetes 30
  • Type 2 Diabetes Mellitus 19
  • Obesity 8
  • Diabetes 6
  • Overweight 4
  • Diabetes Mellitus 4
  • Type 2 Diabetes Mellitus (T2DM) 3
  • Healthy 3
  • Healthy Volunteers 3
  • Gastric Retention 2
  • Type2 Diabetes Mellitus 2
Study Status Phase Start
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
NCT07787936 Miedziowe Centrum Zdrowia SA
Not yet recruiting — January 1, 2027
Metabolic Surgery for Atrial Fibrillation Elimination
NCT07027969 Ali Aminian
Not yet recruiting Phase 4 November 1, 2026
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
NCT07881783 Novartis Pharmaceuticals
Not yet recruiting — October 30, 2026
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus
NCT07677891 ProGen. Co., Ltd.
Not yet recruiting Phase 2 Oct 2026
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
NCT07668336 Eli Lilly and Company
Recruiting Phase 3 July 8, 2026
Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists
NCT07702461 Ohio State University
Recruiting — June 12, 2026
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
NCT07537088 First Affiliated Hospital of Wannan Medical College
Not yet recruiting Phase 4 May 2026
Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis
NCT07282041 National University of Singapore
Recruiting Phase 2, Phase 3 December 17, 2025
Impact of Discontinuing GLP-1 Receptor Agonists for Two Weeks Prior to Upper Endoscopy on the Risk of Gastric Retention
NCT07276763 Fudan University
Not yet recruiting — December 10, 2025
A Phase 3 Study of HS-20094 in Patients With T2DM
NCT07156539 Jiangsu Hansoh Pharmaceutical Co., Ltd.
Not yet recruiting Phase 3 September 30, 2025
Show 40 more studies
Study Status Phase Start
Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
NCT07188545 Ohio State University
Active, not recruiting — September 15, 2025
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
NCT07319286 Ain Shams University
Enrolling by invitation Phase 1, Phase 2 August 4, 2025
A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
NCT07109700 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Recruiting Phase 2 April 30, 2025
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
NCT06739122 Eli Lilly and Company
Recruiting Phase 3 January 10, 2025
Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists
NCT07325435 MaryAnn Banerji
Active, not recruiting Phase 4 December 21, 2024
A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin
NCT06257966 Beijing Dongfang Biotech Co., Ltd.
Active, not recruiting Phase 3 July 17, 2024
GLP_1 RA Ultrasound Study
NCT06581120 Children's Hospital Medical Center, Cincinnati
Enrolling by invitation — July 8, 2024
GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery
NCT06324461 The University of Hong Kong
Recruiting Phase 4 March 20, 2024
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
NCT05478707 AdventHealth Translational Research Institute
Recruiting Phase 2 October 5, 2023
Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD
NCT07309094 Cardenal Herrera University
Recruiting — September 15, 2023
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
NCT05390892 Brigham and Women's Hospital
Recruiting Phase 4 September 26, 2022
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
NCT05220917 Brigham and Women's Hospital
Active, not recruiting — August 1, 2021
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
NCT04731272 University of Pennsylvania
Recruiting Phase 2 July 16, 2021
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
NCT01511393 Novo Nordisk A/S
Enrolling by invitation — Jan 2012
Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
NCT07417631 Brigham and Women's Hospital
Completed — February 3, 2026
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
NCT07417618 Brigham and Women's Hospital
Completed — January 27, 2026
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
NCT07619495 Brigham and Women's Hospital
Completed — January 20, 2026
A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus
NCT07313813 Eli Lilly and Company
Completed Phase 1 December 29, 2025
Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes
NCT07834398 Zagazig University
Completed Phase 3 November 14, 2025
Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial
NCT07820111 Zagazig University
Completed Phase 3 October 18, 2025
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
NCT06851962 Fundación para la Investigación del Hospital Clínico de Valencia
Completed Phase 4 May 26, 2025
Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia
NCT07370922 Ain Shams University
Completed Phase 2 November 22, 2024
Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
NCT06779929 Brigham and Women's Hospital
Completed — November 1, 2024
Residual Gastric Content After Holding of Glucagon-like Peptide-1 Receptor Agonists Before Elective Surgery
NCT06500143 Ciusss de L'Est de l'Île de Montréal
Completed — October 9, 2024
Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
NCT07096063 Brigham and Women's Hospital
Completed — October 1, 2024
Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data
NCT07088718 Brigham and Women's Hospital
Completed — October 1, 2024
Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
NCT06449235 Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Unknown status Phase 4 Sep 2024
Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
NCT06533527 The Cleveland Clinic Results posted
Completed Phase 4 July 31, 2024
A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus
NCT06235086 CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Completed Phase 3 April 8, 2024
A Study of HS-20094 in Patients With T2DM
NCT06901648 Jiangsu Hansoh Pharmaceutical Co., Ltd.
Completed Phase 2 February 6, 2024
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
NCT06148649 Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Completed Phase 2 December 10, 2023
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
NCT05140694 Seoul National University Bundang Hospital
Unknown status Phase 4 December 1, 2023
The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
NCT06331286 First Affiliated Hospital of Zhejiang University
Unknown status N/A September 1, 2023
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
NCT05990374 Nanjing First Hospital, Nanjing Medical University
Unknown status N/A August 1, 2023
Efficacy of Glucagon-like Peptide-1 Receptor Agonists According to Type 2 Diabetes Subtypes
NCT06120556 Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Completed — June 10, 2023
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
NCT05680129 Hangzhou Sciwind Biosciences Co., Ltd.
Completed Phase 3 January 10, 2023
A Study of IBI362 in Participants With Type 2 Diabetes
NCT05606913 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 3 January 6, 2023
A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India
NCT05659537 Eli Lilly and Company Results posted
Completed Phase 4 December 29, 2022
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
NCT05564039 Eli Lilly and Company Results posted
Completed Phase 4 November 30, 2022
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
NCT05516966 Fujian Shengdi Pharmaceutical Co., Ltd.
Completed Phase 1 October 12, 2022

All 143 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
88,461
Serious
23,096
With death outcome
1,698

Most reported reactions

  • Nausea 10,444
  • Injection site pain 9,959
  • Blood glucose increased 9,913
  • Diarrhoea 6,120
  • Vomiting 5,821
  • Incorrect dose administered 5,600
  • Inappropriate schedule of product administration 3,840
  • Drug ineffective 3,682
  • Weight decreased 3,427
  • Decreased appetite 3,262
  • Extra dose administered 3,172
  • Injection site haemorrhage 3,165

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Boxed warning Trulicity · June 16, 2026
Original FDA text (English) WARNING: 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. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), and Nonclinical Toxicology ( 13.1 )] . TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
  • Trulicity HUMAN PRESCRIPTION DRUG Eli Lilly and Company June 16, 2026
  • TRULICITY HUMAN PRESCRIPTION DRUG A-S Medication Solutions July 3, 2025
  • Trulicity HUMAN PRESCRIPTION DRUG A-S Medication Solutions December 12, 2023
  • Trulicity HUMAN PRESCRIPTION DRUG A-S Medication Solutions December 9, 2023
  • TRULICITY HUMAN PRESCRIPTION DRUG A-S Medication Solutions August 5, 2023
  • TRULICITY HUMAN PRESCRIPTION DRUG A-S Medication Solutions May 3, 2023
  • TRULICITY HUMAN PRESCRIPTION DRUG A-S Medication Solutions May 3, 2023

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.