Dulaglutide History and Updates

211 events · 2011 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: September 24, 2026.

FDA Approvals

Label Revisions

324

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-24Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Dulaglutide since 2011, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (12)

2026

Results postedDulaglutide: Tirzepatide Shows Fewer MACE-3 Events in Type 2 Diabetes Trial· Jul 8, 2026
Primary completionDulaglutide trial completed in adults with obesity without diabetes· Apr 13, 2026
Primary completionDulaglutide Phase 3 Trial Comparing Weekly GLP-1 Drugs Completed· Mar 17, 2026
Primary completionDulaglutide: Phase 3 Trial for Type 2 Diabetes Mellitus Completes Primary· Feb 3, 2026
Pivotal publicationDulaglutide Compared to Mazdutide in Chinese Adults with Type 2 Diabetes· Jan 1, 2026

2025

Results postedDulaglutide: Tirzepatide Switch Shows Superior HbA1c and Weight Reduction in…· Aug 3, 2025
Primary completionDulaglutide: Phase 3 Trial vs. Tirzepatide in Type 2 Diabetes Completes· Jun 12, 2025
Results postedDulaglutide Phase 2 Trial for CKD: Intermuscular Fat Reduced by -0.009· Apr 20, 2025
Results postedDulaglutide Phase 4 Trial Posts Safety Data for Type 2 Diabetes in India· Feb 5, 2025

2022

Pivotal publicationDulaglutide Publication Details Treatment for Youths with Type 2 Diabetes· Jan 1, 2022

2019

Pivotal publicationDulaglutide REWIND Trial Results Published for Type 2 Diabetes Cardiovascular…· Jan 1, 2019
Pivotal publicationDulaglutide Renal Outcomes in Type 2 Diabetes: REWIND Exploratory Analysis…· Jan 1, 2019

Upcoming & expected milestones

Trial startedOct 31, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07677891

Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07319286

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

Primary completionMar 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07156539

A Phase 3 Study of HS-20094 in Patients With T2DM

Primary completionApr 30, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07537088

Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07677891

Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

Primary completionDec 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06739122

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Primary completionJun 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 4 primary completion: NCT06324461

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

Primary completionMar 31, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07668336

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Primary completionDec 1, 2030· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT07282041

Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

Past events

2026

Primary completionOct 1, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06257966

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Met

Trial startedSep 30, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07668336

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Trial registeredSep 22, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07834398

Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

Trial registeredSep 15, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07820111

Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07313813

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2

Primary completionAug 13, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT07313813

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2

Results postedJul 8, 2026· ClinicalTrials.gov

Trial results posted: NCT04255433

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Trial registeredJul 1, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07677891

Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06851962

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Trial registeredJun 25, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07668336

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Primary completionJun 19, 2026· ClinicalTrials.gov

Primary completion: NCT07417618

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Primary completionJun 15, 2026· ClinicalTrials.gov

Primary completion: NCT07417631

Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Trial registeredJun 2, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07619495

Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk

Primary completionJun 1, 2026· ClinicalTrials.gov

Primary completion: NCT07619495

Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07537088

Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic

Primary completionMay 22, 2026· ClinicalTrials.gov

Primary completion: NCT07417618

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07319286

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

Trial registeredApr 17, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07537088

Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic

Primary completionApr 13, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT07834398

Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

Primary completionMar 31, 2026· ClinicalTrials.gov

Primary completion: NCT07417618

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Primary completionMar 31, 2026· ClinicalTrials.gov

Primary completion: NCT07417631

Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Primary completionMar 17, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT07820111

Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial

FDA approval (supplemental)Mar 12, 2026· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-65)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial registeredFeb 18, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07417631

Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Trial registeredFeb 18, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07417618

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Trial startedFeb 3, 2026· ClinicalTrials.gov

Trial started: NCT07417631

Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Primary completionFeb 3, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06235086

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

Primary completionJan 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Trial startedJan 27, 2026· ClinicalTrials.gov

Trial started: NCT07417618

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Trial registeredJan 27, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07370922

Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia

Trial registeredJan 6, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07319286

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

Trial registeredJan 2, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07313813

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2

Pivotal publicationJan 1, 2026· PubMed

Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. (Nature)

A Study of IBI362 in Participants With Type 2 Diabetes

2025

Trial startedDec 29, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT07313813

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2

Trial startedDec 17, 2025· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT07282041

Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

Trial registeredDec 15, 2025· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT07282041

Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

Primary completionDec 1, 2025· ClinicalTrials.gov

Primary completion: NCT06779929

Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2

Primary completionNov 22, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT07370922

Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia

Trial startedSep 30, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07156539

A Phase 3 Study of HS-20094 in Patients With T2DM

Trial registeredSep 5, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07156539

A Phase 3 Study of HS-20094 in Patients With T2DM

Trial registeredAug 7, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Trial startedAug 4, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07319286

Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

Results postedAug 3, 2025· ClinicalTrials.gov

Trial results posted: NCT05564039

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Trial registeredJul 31, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07096063

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Primary completionJul 30, 2025· ClinicalTrials.gov

Primary completion: NCT07088718

Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

Trial registeredJul 28, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07088718

Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

Primary completionJul 15, 2025· ClinicalTrials.gov

Primary completion: NCT07096063

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Primary completionJun 12, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04255433

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

FDA approval (supplemental)May 28, 2025· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-63)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial startedMay 26, 2025· ClinicalTrials.gov

Phase 4 trial started: NCT06851962

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Trial startedApr 30, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Results postedApr 20, 2025· ClinicalTrials.gov

Trial results posted: NCT05254418

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Trial registeredMar 30, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06901648

A Study of HS-20094 in Patients With T2DM

Primary completionMar 7, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06901648

A Study of HS-20094 in Patients With T2DM

Trial registeredFeb 28, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06851962

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Primary completionFeb 27, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06148649

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Results postedFeb 5, 2025· ClinicalTrials.gov

Trial results posted: NCT05659537

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

Results postedJan 17, 2025· ClinicalTrials.gov

Trial results posted: NCT04862234

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Trial registeredJan 17, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06779929

Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2

Results postedJan 14, 2025· ClinicalTrials.gov

Trial results posted: NCT04515576

A Study of LY3493269 in Participants With Type 2 Diabetes

Trial startedJan 10, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06739122

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

2024

Primary completionDec 31, 2024· ClinicalTrials.gov

NA primary completion: NCT06331286

The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity

Trial registeredDec 18, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06739122

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Results postedDec 5, 2024· ClinicalTrials.gov

Trial results posted: NCT04387201

GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response

Trial startedNov 22, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT07370922

Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia

FDA approval (supplemental)Nov 1, 2024· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-61)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial startedNov 1, 2024· ClinicalTrials.gov

Trial started: NCT06779929

Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2

FDA approval (supplemental)Nov 1, 2024· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-62)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Primary completionOct 30, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05218915

Basal Plus GLP1-ra on Glycemic Variability in CKD

Trial startedOct 1, 2024· ClinicalTrials.gov

Trial started: NCT07088718

Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data

Trial startedOct 1, 2024· ClinicalTrials.gov

Trial started: NCT07096063

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Trial registeredSep 25, 2024· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06611904

The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Typ

Trial startedJul 17, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06257966

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Met

Primary completionJul 15, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05564039

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Primary completionJul 3, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05680129

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Primary completionJun 30, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05140694

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Results postedMay 30, 2024· ClinicalTrials.gov

Trial results posted: NCT03743025

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Primary completionMay 1, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05254418

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Trial startedApr 8, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06235086

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

Trial registeredMar 26, 2024· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06331286

The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity

Trial registeredMar 22, 2024· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06324461

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

Trial startedMar 20, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT06324461

GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery

Trial registeredFeb 14, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06257966

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Met

Trial startedFeb 6, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06901648

A Study of HS-20094 in Patients With T2DM

Trial registeredJan 31, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06235086

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

Primary completionJan 26, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

Primary completionJan 16, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05659537

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

Results postedJan 16, 2024· ClinicalTrials.gov

Trial results posted: NCT02759107

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Primary completionJan 12, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05407961

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

2023

Primary completionDec 31, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT05005741

The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

Trial registeredDec 27, 2023· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT06182891

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Trial startedDec 10, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT06148649

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Trial startedDec 1, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT05140694

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Trial registeredNov 28, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06148649

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Primary completionNov 22, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05377333

A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Primary completionNov 1, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05348122

A Study of TG103 Injection in Type 2 Diabetes Subjects

Results postedOct 17, 2023· ClinicalTrials.gov

Trial results posted: NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Primary completionOct 6, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT04387201

GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response

Trial startedOct 5, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Primary completionSep 30, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT03648554

Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)

Results postedSep 21, 2023· ClinicalTrials.gov

Trial results posted: NCT04809220

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

Trial startedSep 1, 2023· ClinicalTrials.gov

NA trial started: NCT06331286

The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity

Label revisionAug 5, 2023· FDA

Boxed warning present on label on TRULICITY label (effective 2023-08-05)

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 u

Trial registeredJul 14, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05946148

Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

Results postedJul 3, 2023· ClinicalTrials.gov

Trial results posted: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Primary completionJun 30, 2023· ClinicalTrials.gov

NA primary completion: NCT06182891

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Primary completionJun 22, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT04862234

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Results postedMay 24, 2023· ClinicalTrials.gov

Trial results posted: NCT04591626

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

Primary completionMay 24, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05516966

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes

Primary completionMay 2, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT03743025

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Trial registeredJan 11, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05680129

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Trial startedJan 10, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05680129

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Trial startedJan 6, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

2022

Trial startedDec 29, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05659537

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

Trial registeredDec 21, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05659537

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India

Trial startedNov 30, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05564039

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

FDA approval (supplemental)Nov 17, 2022· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Efficacy (BLA 125469 S-51)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Trial registeredNov 7, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

Trial startedOct 12, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05516966

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes

Trial registeredOct 3, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05564039

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Primary completionOct 1, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04809220

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

Primary completionSep 30, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Primary completionSep 5, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04687514

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Trial registeredAug 26, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05516966

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes

Primary completionJul 30, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT03204396

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

Trial registeredJul 28, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Trial registeredJul 14, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05459285

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Primary completionJul 8, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Primary completionJul 2, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05459285

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Results postedJul 1, 2022· ClinicalTrials.gov

Trial results posted: NCT02963766

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Trial startedJun 15, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05348122

A Study of TG103 Injection in Type 2 Diabetes Subjects

FDA approval (supplemental)Jun 10, 2022· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-46)

Sponsor: ELI LILLY AND CO. Class: Labeling.

FDA approval (supplemental)Jun 10, 2022· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-52)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial startedJun 7, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05407961

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Trial registeredJun 7, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05407961

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Trial startedJun 2, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05377333

A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Trial startedMay 31, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05459285

A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Trial registeredMay 17, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05377333

A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Primary completionApr 28, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04591626

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

Trial registeredApr 27, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05348122

A Study of TG103 Injection in Type 2 Diabetes Subjects

Results postedApr 14, 2022· ClinicalTrials.gov

Trial results posted: NCT03861052

A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes

RecallApr 5, 2022· FDA

TRULICITY recall — Class II: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

Trial startedMar 15, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05254418

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Trial registeredFeb 24, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05254418

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Primary completionFeb 5, 2022· ClinicalTrials.gov

NA primary completion: NCT06611904

The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Typ

Trial registeredFeb 1, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05218915

Basal Plus GLP1-ra on Glycemic Variability in CKD

Trial startedJan 28, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05218915

Basal Plus GLP1-ra on Glycemic Variability in CKD

Pivotal publicationJan 1, 2022· PubMed

Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. (N Engl J Med)

AWARD-PEDS — A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

2021

Primary completionDec 30, 2021· ClinicalTrials.gov

Phase 4 primary completion: NCT04893148

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Primary completionDec 21, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04641312

A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

Trial registeredDec 1, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05140694

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Primary completionNov 30, 2021· ClinicalTrials.gov

Phase 4 primary completion: NCT03444142

Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes

Results postedNov 1, 2021· ClinicalTrials.gov

Trial results posted: NCT03684642

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Trial startedOct 30, 2021· ClinicalTrials.gov

NA trial started: NCT06182891

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

FDA approval (supplemental)Sep 30, 2021· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Labeling (BLA 125469 S-44)

Sponsor: ELI LILLY AND CO. Class: Labeling.

Trial registeredSep 17, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Trial startedSep 15, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05048719

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

RecallAug 19, 2021· FDA

TRULICITY recall — Class II: Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg /

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

Trial registeredAug 13, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05005741

The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

Trial startedAug 6, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04862234

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Trial startedJul 16, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

Primary completionJun 12, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT02963766

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Primary completionMay 31, 2021· ClinicalTrials.gov

Primary completion: NCT05946148

Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

Primary completionMay 28, 2021· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Trial registeredMay 19, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04893148

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Trial startedMay 13, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial startedMay 5, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04687514

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Trial startedMay 1, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT05005741

The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

Trial registeredApr 30, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial registeredApr 27, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04862234

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Trial startedApr 13, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04809220

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

Trial registeredApr 2, 2021· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT04829903

Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

Primary completionMar 29, 2021· ClinicalTrials.gov

NA primary completion: NCT04829903

Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

Trial registeredMar 22, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04809220

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

Primary completionMar 10, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03861052

A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes

Primary completionMar 9, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04515576

A Study of LY3493269 in Participants With Type 2 Diabetes

Results postedFeb 17, 2021· ClinicalTrials.gov

Trial results posted: NCT04189848

Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

Primary completionFeb 3, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT03668470

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

Primary completionJan 31, 2021· ClinicalTrials.gov

Primary completion: NCT04374578

Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes

Trial registeredJan 29, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

2020

Trial registeredDec 29, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04687514

Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

Primary completionDec 28, 2020· ClinicalTrials.gov

Phase 1 primary completion: NCT04143802

A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

Trial startedDec 7, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04591626

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

Trial startedNov 25, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04641312

A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

Trial registeredNov 23, 2020· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04641312

A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

Trial registeredOct 19, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04591626

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

Primary completionOct 13, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03684642

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Trial startedSep 12, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

FDA approval (supplemental)Sep 3, 2020· FDA

FDA approved supplemental application for Trulicity (dulaglutide) — Efficacy (BLA 125469 S-36)

Sponsor: ELI LILLY AND CO. Class: Efficacy.

Trial startedAug 25, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04515576

A Study of LY3493269 in Participants With Type 2 Diabetes

Trial registeredAug 17, 2020· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04515576

A Study of LY3493269 in Participants With Type 2 Diabetes

Trial registeredJul 10, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Results postedJun 12, 2020· ClinicalTrials.gov

Trial results posted: NCT03495102

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Trial startedMay 29, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04255433

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Trial startedMay 26, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04893148

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Trial startedMay 15, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT04387201

GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response

Trial registeredMay 13, 2020· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04387201

GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response

Trial startedMay 8, 2020· ClinicalTrials.gov

Trial started: NCT04374578

Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes

Trial registeredMay 5, 2020· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04374578

Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.