Drugs / Dulaglutide
Dulaglutide
also known as
LY2189265 · dulaglutide injection · Trulicity · Dulaglutida · dulaglutide (Trulicity) · Dulaglutide component of trulicity
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 3 milestones | |||||
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2024-05-28 | “度 拉 糖 肽 注 射 液（BA5101）的 上 市 申 请（BLA）已 获 得 中 国 国 家 药 品 监 督 管 理 局 药 品 审 评 中 心 受 理” luye.com ↗ |
| Filed | EU (EMA) | — | type 2 diabetes mellitus | — | “U.S. and European regulatory submissions for two medicines to treat type 2 diabetes: empagliflozin (with partner Boehringer Ingelheim) and dulaglutide.” lilly.com ↗ “Dulaglutide was submitted for regulatory review in both the U.S. and Europe as a potential treatment for type 2 diabetes.” lilly.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | — | “U.S. and European regulatory submissions for two medicines to treat type 2 diabetes: empagliflozin (with partner Boehringer Ingelheim) and dulaglutide.” lilly.com ↗ “Dulaglutide was submitted for regulatory review in both the U.S. and Europe as a potential treatment for type 2 diabetes.” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | TRULICITY | — | 2017-01-27 – 2022-11-17 | fda.gov ↗ |
| Approved | EU (EMA) | Trulicity | — | 2014-11-21 | europa.eu ↗ |
| Approved | US (FDA) | TRULICITY | — | 2014-09-18 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials · 2 met primary · 1 missed | ||||||
| Phase 1 | NCT07313813 | Dec 2025 → Aug 2026 overdue | type 2 diabetes mellitus | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03363906 | Dec 2017 → Jun 2018 | — | Eli Lilly and Company | Completed | Missed primary |
| Phase 1 | NCT01667900 | Aug 2012 → Jun 2014 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01524770 | Mar → Jun 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01458210 | Oct 2011 → Feb 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01436201 | Sep → Nov 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01432938 | Sep → Dec 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01408888 | Aug 2011 → Apr 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01324388 | Mar → Aug 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01301092 | Feb → Aug 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01300260 | Feb → Aug 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT01250834 | Dec 2010 → Mar 2011 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01253304 | Nov 2010 → Nov 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01215968 | Sep 2010 → Jul 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04466904 | Sep 2020 → May 2021 | type 2 diabetes mellitus | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 212 trials · 6 met primary | ||||||
| Phase 2 | NCT07370922 | Nov 2024 → Nov 2025 | beta-thalassemia major | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT06148649 | Dec 2023 → Feb 2025 | type 2 diabetes mellitus | Dongguan HEC Biopharmaceutical R&D Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05254418 | Mar 2022 → May 2024 | chronic kidney disease | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04731272 | Jul 2021 → Jun 2027 expected | cystic fibrosis, diabetes mellitus, exocrine pancreatic insufficiency, glucose intolerance | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT04687514 | May 2021 → Sep 2022 | physiological sexual disorder | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT03668470 | Jan 2019 → Feb 2021 | type 1 diabetes mellitus | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 2 | NCT02973100 | Dec 2016 → Jul 2017 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT02770885 | Mar 2016 → May 2019 | primary polydipsia | University Hospital, Basel, Switzerland | Completed | Met primary |
| Phase 2 | NCT01149421 | Jun 2010 → Sep 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT01001104 | Oct 2009 → Dec 2010 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00791479 | Dec 2008 → Jan 2010 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00630825 | Apr 2008 → Jan 2009 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07282041 | Dec 2025 → Dec 2030 expected | intracranial arteriosclerosis, ischemic stroke | National University of Singapore | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00734474 | Aug 2008 → Jun 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 323 trials · 21 met primary | ||||||
| Phase 3 | NCT06739122 | Jan 2025 → Dec 2027 expected | type 2 diabetes mellitus | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06235086 | Apr 2024 → Feb 2026 | type 2 diabetes mellitus | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05606913 | Jan 2023 → Jan 2024 | type 2 diabetes mellitus | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 3 | NCT04809220 | Apr 2021 → Oct 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04591626 | Dec 2020 → Apr 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT04255433 | May 2020 → Jun 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03495102 | Apr 2018 → May 2019 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02963766 | Dec 2016 → Jun 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02597049 | Nov 2015 → Feb 2017 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02152371 | May 2014 → Oct 2015 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01769378 | Jan 2013 → Dec 2014 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01644500 | Jul 2012 → Aug 2014 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01621178 | Jul 2012 → Jun 2016 | chronic kidney disease, type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01648582 | Jul 2012 → Aug 2014 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01624259 | Jun 2012 → Nov 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01584232 | Apr 2012 → Jul 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01558271 | Mar 2012 → Oct 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01468181 | Nov 2011 → Dec 2013 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01394952 | Jul 2011 → Aug 2018 | cardiovascular disorder, type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01191268 | Nov 2010 → Feb 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01126580 | May 2010 → Nov 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01064687 | Feb 2010 → Nov 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01075282 | Feb 2010 → May 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 417 trials · 3 met primary | ||||||
| Phase 4 | NCT07027969 | Nov 2026 → Dec 2029 expected | atrial fibrillation, obesity disorder | Ali Aminian | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07537088 | May 2026 → Apr 2027 expected | chronic kidney disease, type 2 diabetes mellitus | First Affiliated Hospital of Wannan Medical College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06851962 | May 2025 → Jun 2026 | type 2 diabetes mellitus | Fundación para la Investigación del Hospital Clínico de Valencia | Completed | No outcome recorded |
| Phase 4 | NCT06324461 | Mar 2024 → Dec 2028 expected | — | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT05140694 | Dec 2023 → Jun 2024 | metabolic dysfunction-associated steatotic liver disease, type 2 diabetes mellitus | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05659537 | Dec 2022 → Jan 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT05218915 | Jan 2022 → Oct 2024 | diabetes mellitus, diabetic kidney disease | Elaine Chow | Completed | No outcome recorded |
| Phase 4 | NCT04862234 | Aug 2021 → Jun 2023 | hyperglycemia | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT04876027 | May 2021 → Apr 2022 | polycystic ovary syndrome | Shanghai 10th People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04387201 | May 2020 → Oct 2023 | glucose intolerance, obesity disorder | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT04135287 | Mar 2020 → Mar 2023 | type 2 diabetes mellitus | Dasman Diabetes Institute | Unknown | No outcome recorded |
| Phase 4 | NCT04189848 | Dec 2019 → Jan 2020 | obesity disorder, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT03648554 | Sep 2019 → Sep 2023 | metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 4 | NCT03743025 | Mar 2019 → May 2023 | hyperglycemia | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT03315780 | Oct 2017 → Feb 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT03824002 | Apr → Oct 2017 | type 2 diabetes mellitus | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT02750410 | Aug 2016 → Jun 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT06331286 | Sep 2023 → Dec 2024 | bipolar disorder, obesity disorder | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| — | NCT06182891 | Oct 2021 → Jun 2023 | diabetic kidney disease | The Affiliated Hospital of Xuzhou Medical University | Completed | No outcome recorded |
| — | NCT03590626 | Jan 2019 → Jan 2020 | fatty liver disease, type 2 diabetes mellitus | Medanta, The Medicity, India | Completed | Met primary |
| — | NCT03498001 | Apr 2018 → Jun 2023 | type 2 diabetes mellitus | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Comparator or background therapy42 trials | ||||||
| Phase 1 | NCT05516966 Comparator | Oct 2022 → May 2023 | type 2 diabetes mellitus | Fujian Shengdi Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05407961 Background | Jun 2022 → Jan 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05377333 Background | Jun 2022 → Nov 2023 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05459285 Comparator | May → Jul 2022 | type 2 diabetes mellitus | Sunshine Lake Pharma Co., Ltd. | Completed | Met primary |
| Phase 1 | NCT04641312 Background | Nov 2020 → Dec 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04515576 Comparator | Aug 2020 → Mar 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04143802 Comparator | Dec 2019 → Dec 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02759107 Comparator | May 2016 → Jun 2017 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT07319286 Comparator | Aug 2025 → Dec 2026 expected | menstrual disorder, type 1 diabetes mellitus | Ain Shams University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07677891 Comparator | Oct 2026 → May 2027 expected | type 2 diabetes mellitus | ProGen. Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07109700 Comparator | Apr 2025 → Jan 2026 overdue | type 2 diabetes mellitus | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06901648 Comparator | Feb 2024 → Mar 2025 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05478707 Comparator | Oct 2023 → Jun 2028 | type 1 diabetes mellitus | University of Virginia | Suspended | No outcome recorded |
| Phase 2 | NCT05348122 Comparator | Jun 2022 → Nov 2023 | type 2 diabetes mellitus | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05048719 Comparator | Sep 2021 → Sep 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT04867785 Comparator | May 2021 → Jul 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT03962010 Comparator | Jun 2019 → Jun 2022 | type 2 diabetes mellitus | Genexine, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT03204396 Comparator | Jun 2017 → Jul 2022 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT03131687 Comparator | May 2017 → Aug 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT03141632 Comparator | Oct 2016 → May 2017 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 3 | NCT07668336 Comparator | Sep 2026 → Mar 2030 expected | type 2 diabetes mellitus | Eli Lilly and Company | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07834398 Comparator | Nov 2025 → Apr 2026 | obesity disorder | Zagazig University | Completed | No outcome recorded |
| Phase 3 | NCT07820111 Comparator | Oct 2025 → Mar 2026 | — | Zagazig University | Completed | No outcome recorded |
| Phase 3 | NCT07156539 Comparator | Sep 2025 → Mar 2027 expected | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06257966 Comparator | Jul 2024 → Oct 2026 expected | type 2 diabetes mellitus | Beijing Dongfang Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05680129 Comparator | Jan 2023 → Jul 2024 | type 2 diabetes mellitus | Hangzhou Sciwind Biosciences Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03861052 Comparator | May 2019 → Mar 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03684642 Comparator | Sep 2018 → Oct 2020 | type 2 diabetes mellitus | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03015220 Comparator | Jan 2017 → Jul 2018 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02787551 Comparator | Jul 2016 → May 2018 | type 2 diabetes mellitus | Sanofi | Completed | Met primary |
| Phase 3 | NCT02648204 Comparator | Jan 2016 → Apr 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT07325435 Comparator | Dec 2024 → Dec 2027 expected | type 2 diabetes mellitus | MaryAnn Banerji | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06533527 Comparator | Jul 2024 → May 2025 | gastroparesis, obesity disorder, type 2 diabetes mellitus | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT05564039 Comparator | Nov 2022 → Jul 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT05390892 Comparator | Sep 2022 → Mar 2029 expected | atherosclerotic cardiovascular disease, type 2 diabetes mellitus | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05005741 Comparator | May 2021 → Dec 2023 | obesity disorder, type 2 diabetes mellitus | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 4 | NCT04893148 Comparator | May 2020 → Dec 2021 | hyperglycemia, type 2 diabetes mellitus | Chungbuk National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03444142 Comparator | Nov 2017 → Nov 2021 | type 2 diabetes mellitus | University of Guadalajara | Unknown | No outcome recorded |
| — | NCT04829903 Comparator | Jan 2020 → Mar 2021 | obesity disorder, type 2 diabetes mellitus | Corporacion Parc Tauli | Completed | No outcome recorded |
| — | NCT06611904 Comparator | Feb 2018 → Feb 2022 overdue | arteriosclerosis disorder, proteinuria | Attikon Hospital | Active not recruiting | No outcome recorded |
| — | NCT02846233 Comparator | Aug 2016 → Dec 2018 | type 2 diabetes mellitus | University of California, San Francisco | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 44
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Eli Lilly and Company | Results FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes lilly.com ↗
In the trial, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3). |
| 2026-05-28 | Eli Lilly and Company | Results Lilly to present new data on Foundayo, Mounjaro and retatrutide at the American Diabetes Association's 86th Scientific Sessions, building toward a new era of choice in diabetes and obesity care lilly.com ↗
SURPASS-CVOT: Mounjaro and dulaglutide demonstrated improvements in quality of life and daily functioning over the course of multiple years of treatment. |
| 2025-08-08 | Luye Pharma Group Ltd. | Regulatory 首个国产度拉糖肽注射液博优平®获批上市 luye.com ↗
2025年8月8日，山 东 烟 台——博 安 生 物 宣 布，其 自 主 研 发 的 博 优 平®（度 拉 糖 肽 注 射 液）已 获 得 国 家 药 品 监 督 管 理 局 的 上 市 批 准，用 于 成 人2型 糖 尿 病 患 者 的 血 糖 控 制. |
| 2025-07-31 | Eli Lilly and Company | Results Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease lilly.com ↗
In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack or stroke vs. Trulicity. |
| 2024-09-12 | Innovent Biologics (Suzhou) Co. Ltd. | Results Head-to-head Superiority over Dulaglutide: Innovent’s Phase 3 Clinical Trial DREAMS-2 of Mazdutide in Chinese Patients with Type 2 Diabetes were Orally Presented at EASD 2024 innoventbio.com ↗
The study results demonstrated the superiority of mazdutide to dulaglutide in both glycemic control and body weight reduction in Chinese participants with T2D. |
| 2024-09-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Annouces Multiple Clinical Study Results of Mazdutide to be Presented at the EASD 2024 innoventbio.com ↗
dutide is the first GLP-1R/GCGR dual agonist to successfully complete a Phase 3 study for diabetes, demonstrating superior blood sugar-lowering and weight loss efficacy compared to dulaglutide. |
| 2024-08-06 | Annovis Bio Inc. | Results Annovis’ Lead Compound Enhances Cognition Synergistically with GLP-1 Agonist annovisbio.com ↗
Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced new preclinical data demonstrating the synergistic effect of its lead compound, buntanetap, when combined with the glucagon-like peptide 1 (GLP-1) agonist dulaglutide (Trulicity®) in a mouse model of Alzheimer’s disease. |
| 2024-05-28 | Luye Pharma Group Ltd. | Regulatory 国内首个！博安生物度拉糖肽注射液BA5101在华上市申请获受理 luye.com ↗
博 安 生 物 宣 布，其 自 主 研 发 的 度 拉 糖 肽 注 射 液（BA5101）的 上 市 申 请（BLA）已 获 得 中 国 国 家 药 品 监 督 管 理 局 药 品 审 评 中 心 受 理，用 于 成 人2型 糖 尿 病 患 者 的 血 糖 控 制. |
| 2024-05-09 | Innovent Biologics (Suzhou) Co. Ltd. | Results Head-to-head Superiority to High-dose Dulaglutide: Innovent’s First Phase 3 Clinical Trial of Mazdutide in Chinese Patients with Type 2 Diabetes Met Study Endpoints innoventbio.com ↗
After 28 weeks of treatment, mazdutide 4.0 mg and mazdutide 6.0 mg showed non-inferiority to dulaglutide 1.5 mg in terms of improvement in HbA1c level from baseline. |
| 2023-06-23 | Eli Lilly and Company | Results Lilly's phase 2 results published in the New England Journal of Medicine show orforglipron, a once-daily oral nonpeptide GLP-1 receptor agonist, achieved up to 14.7% mean weight reduction at 36 weeks in adults with obesity or overweight lilly.com ↗
In that study, for the efficacy estimand, mean reduction in A1C (from a mean baseline of 8.1%) with orforglipron at 26 weeks was up to 2.1% compared to 0.4% with placebo and 1.1% with dulaglutide. |
| 2022-06-04 | Eli Lilly and Company | Results Lilly's AWARD-PEDS trial investigating use of Trulicity® (dulaglutide) in youth and adolescents with type 2 diabetes showed superiority in A1C reduction vs placebo lilly.com ↗
Among patients treated with Trulicity (pooled data), 51.5% reached an A1C of <7% based on treatment regimen estimand. |
| 2021-12-08 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Releases Results of a Phase 1 Clinical Study of IBI362, a Dual Glucagon-like Peptide-1 and Glucagon Receptor Agonist in Chinese Patients with Type 2 Diabetes at the International Diabetes Federation Congress 2021 innoventbio.com ↗
At week 12, mean changes from baseline in HbA1c levels were −1.46%, −2.23% and −1.66% for patients receiving IBI362 in cohort 1,2 and 3, respectively (−1.98% for dulaglutide). |
| 2020-09-03 | Eli Lilly and Company | Regulatory FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company's (NYSE: LLY) Trulicity® (dulaglutide). |
| 2020-06-13 | Eli Lilly and Company | Results Once-weekly Trulicity® (dulaglutide) demonstrates significantly higher adherence and more persistence compared to once-weekly semaglutide and exenatide injections lilly.com ↗
New real-world data showed Trulicity® (dulaglutide) had significantly higher adherence and longer persistence compared to weekly injections of semaglutide or exenatide (BCise pen) in people with type 2 diabetes new to GLP-1 receptor agonist (RA) treatment. |
| 2020-05-08 | Eli Lilly and Company | Results Higher investigational doses of Trulicity® (dulaglutide) meaningfully reduced A1C and body weight in people with type 2 diabetes lilly.com ↗
New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions up to 10.4 pounds in people with type 2 diabetes. |
| 2020-02-21 | Eli Lilly and Company | Regulatory Trulicity® (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Trulicity® (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors. |
| 2019-09-20 | Eli Lilly and Company | Regulatory CHMP Issues Positive Opinion to Expand Trulicity® (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial lilly.com ↗
INDIANAPOLIS, Sept. 20, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency'sCommittee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to the Trulicity® (dulaglutide) label and indication statement. |
| 2019-07-30 | Eli Lilly and Company | Results Lilly Reports Second-Quarter 2019 Financial Results, Raises 2019 EPS Guidance lilly.com ↗
The trial also met the secondary efficacy endpoint for superiority on weight reduction. |
| 2019-06-26 | Eli Lilly and Company | Results Lilly's AWARD-11 trial studying higher investigational doses of Trulicity® (dulaglutide) demonstrated superiority in A1C reduction in people with type 2 diabetes lilly.com ↗
The trial also met the secondary efficacy endpoint for superiority on weight reduction. |
| 2019-06-09 | Eli Lilly and Company | Results Trulicity® (dulaglutide) significantly reduced major cardiovascular events for broad range of people with type 2 diabetes lilly.com ↗
Detailed results from REWIND, the Trulicity® (dulaglutide) cardiovascular outcome trial, showed a significant 12 percent reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), non-fatal stroke or CV death. |
| 2018-11-05 | Eli Lilly and Company | Results Trulicity® (dulaglutide) demonstrates superiority in reduction of cardiovascular events for broad range of people with type 2 diabetes lilly.com ↗
Trulicity® (dulaglutide) significantly reduced major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke, meeting the primary efficacy objective in the precedent-setting REWIND trial. |
| 2018-09-20 | Novo Nordisk A/S | Results Novo Nordisk - Oral semaglutide demonstrates greater reductions in HbA1c and body weight and comparable number of adverse events vs dulaglutide in Japanese people with type 2 diabetes novonordisk.com ↗
The trial achieved its primary objective by demonstrating a comparable number of adverse events with oral semaglutide compared to 0.75 mg dulaglutide. |
| 2018-07-19 | Eli Lilly and Company | Regulatory Lilly's Once-Weekly Trulicity® (dulaglutide) Label Updated to Include Data Showing Benefits for Adults with Type 2 Diabetes and Chronic Kidney Disease lilly.com ↗
The U.S. label for Eli Lilly and Company's (NYSE: LLY) once-weekly Trulicity® (dulaglutide) is updated to show the medicine's safety and efficacy in people with type 2 diabetes who have moderate to severe chronic kidney disease (CKD). |
| 2018-06-24 | Eli Lilly and Company | Results Real-World Data Show Advantages in People Treated with Lilly's Once-Weekly Trulicity® (dulaglutide) Compared to Those Treated with Liraglutide and Exenatide QW lilly.com ↗
These real-world data show that people starting on once-weekly Trulicity are associated with a higher likelihood of adhering to their treatment regimen and having a lower A1C compared to two other GLP-1 RA options. |
| 2018-06-23 | Eli Lilly and Company | Results Investigational Doses of Lilly's Once-Weekly Trulicity® (dulaglutide) Show Promise in Delivering Powerful Efficacy in People with Type 2 Diabetes lilly.com ↗
Two investigational doses of Lilly's dulaglutide (4.5 mg and 3.0 mg), as well as Trulicity® (dulaglutide) 1.5 mg, provided significantly better blood sugar control with weight benefits compared to placebo in adults with type 2 diabetes. |
| 2018-02-26 | Eli Lilly and Company | Results New Data Show Lilly's Trulicity® (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes lilly.com ↗
Trulicity® (dulaglutide) significantly improves A1C (average blood sugar concentration over two to three months) when added to ongoing treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, according to results from AWARD-10, a new Phase 3b clinical study. |
| 2017-09-05 | Adocia | Results Adocia Announces Two Data Presentations at the 53rd Annual Meeting of the European Association for the Study of Diabetes adocia.com ↗
The present poster demonstrates that the proprietary BioChaperone® technology enables solubilization of insulin glargine at neutral pH, which in turns allows its combination with multiple GLP -1 receptor agonists in solution. |
| 2017-08-16 | Novo Nordisk A/S | Results Semaglutide superior to dulaglutide on glucose control and weight loss in people with type 2 diabetes in SUSTAIN 7 novonordisk.com ↗
Novo Nordisk today announced the SUSTAIN 7 trial results, demonstrating that people with type 2 diabetes treated with once-weekly semaglutide experienced superior reduction in HbA1c and body weight compared to treatment with dulaglutide. |
| 2017-02-08 | Eli Lilly and Company | Regulatory Lilly's Trulicity® (dulaglutide) Label Updated to Include Use in Combination with Basal Insulin for Adults with Type 2 Diabetes lilly.com ↗
The label for Eli Lilly and Company's (NYSE: LLY) once-weekly Trulicity® (dulaglutide) is now updated to include use in combination with basal insulin for adults with type 2 diabetes. |
| 2016-06-12 | Eli Lilly and Company | Results New Data Show Lilly's Once-Weekly Trulicity® (dulaglutide) in Combination with Insulin Glargine Improves Glycemic Control in People with Type 2 Diabetes lilly.com ↗
After 28 weeks of treatment, Trulicity 1.5 mg plus insulin glargine significantly reduced A1C from baseline (1.44 percent) compared to placebo with insulin glargine (0.67 percent). |
| 2015-12-01 | Eli Lilly and Company | Results New Data Show Lilly's Once-Weekly Trulicity® (dulaglutide) is Effective as Add-on Treatment to Sulfonylurea lilly.com ↗
New data from a completed Phase 3 trial show Trulicity® (dulaglutide) 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment. |
| 2015-06-08 | Eli Lilly and Company | Results New Data Show Superiority of Lilly's Once-Weekly Trulicity™ (dulaglutide) to Lantus® (insulin glargine) in Patients with Type 2 Diabetes lilly.com ↗
After 26 weeks, both doses of Trulicity were superior to Lantus in A1C reduction, and significantly more patients reached the recommended A1C target of less than 7 percent. |
| 2015-06-06 | Eli Lilly and Company | Results Study: Once-Weekly Trulicity™ (dulaglutide) Provides Greater Blood Sugar Reduction Compared to Once-Daily Victoza® (liraglutide) in Japanese Patients after 52 weeks lilly.com ↗ |
| 2015-05-27 | Eli Lilly and Company | Results Lilly to Present New Clinical Data at 75th American Diabetes Association® Scientific Sessions lilly.com ↗
Among these presentations are new data comparing the safety and efficacy of Trulicity to other common diabetes medicines in multinational patient populations, and a meta-analysis showing no increased risk of cardiovascular events in patients taking Trulicity. |
| 2014-09-18 | Eli Lilly and Company | Regulatory FDA Approves Trulicity™ (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes lilly.com ↗
Trulicity™ (dulaglutide), approved today by the U.S. Food and Drug Administration, is the latest Eli Lilly and Company (NYSE: LLY) treatment option for adults with type 2 diabetes. |
| 2014-06-16 | Eli Lilly and Company | Results Lilly Announces Detailed Results from Two Phase III Studies Testing Both Doses of Dulaglutide vs. Insulin Glargine lilly.com ↗
SAN FRANCISCO, June 16, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. |
| 2014-06-14 | Eli Lilly and Company | Results Lilly's Once-Weekly Dulaglutide Shows Similar Reductions in Average Blood Glucose Levels as Once-Daily Liraglutide in Head-to-Head Trial lilly.com ↗
At the primary endpoint of 26 weeks, once-weekly dulaglutide 1.5 mg and once-daily liraglutide 1.8 mg significantly reduced HbA1c levels from baseline (-1.42 percent and -1.36 percent, respectively), with dulaglutide demonstrating non-inferiority compared to liraglutide. |
| 2014-02-25 | Eli Lilly and Company | Results Lilly's Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes lilly.com ↗
In the AWARD-6 study, once-weekly dulaglutide 1.5 mg achieved the primary endpoint of non-inferiority to once-daily liraglutide 1.8 mg, as measured by the reduction of hemoglobin A1c (HbA1c) from baseline at 26 weeks. |
| 2013-09-26 | Eli Lilly and Company | Results Data Presented at 49th EASD Annual Meeting Show Treatment with Lilly's Investigational Dulaglutide Resulted in Improved Patient-Reported Health Outcomes lilly.com ↗
The patient-reported outcomes from the AWARD-1 trial showed that treatment satisfaction, as measured by the DTSQ, was significantly higher with dulaglutide compared to baseline, and was significantly greater compared to placebo and exenatide twice-daily at 26 weeks. |
| 2013-06-22 | Eli Lilly and Company | Results Lilly's Investigational GLP-1 Receptor Agonist, Dulaglutide, Showed Superior Glycemic Control Versus Comparators in Patients with Type 2 Diabetes lilly.com ↗
In the trials, dulaglutide 1.5 mg was superior to placebo and to exenatide (AWARD-1),[1] metformin (AWARD-3)[2] and sitagliptin (AWARD-5) in reducing HbA1c (hemoglobin A1c) levels. |
| 2013-04-16 | Eli Lilly and Company | Results Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes lilly.com ↗
The dulaglutide 1.5 mg dose demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimeperide (AWARD-2). |
| 2012-10-22 | Eli Lilly and Company | Results Lilly Diabetes Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes lilly.com ↗
Primary efficacy endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at the 1.5 mg dose, were met in three studies (AWARD-1, AWARD-3 and AWARD-5). |
| 2012-05-22 | Eli Lilly and Company | Results Lilly Diabetes Presents Phase II Blood Pressure and Heart Rate Data on Investigational GLP-1 Analog Candidate, Dulaglutide, in Patients with Type 2 Diabetes at the 27th American Society of Hypertension Scientific Meeting lilly.com ↗
In addition, the 1.5 mg dulaglutide dose significantly reduced mean 24-hour SBP compared to placebo. |
| 2009-06-06 | Eli Lilly and Company | Results Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes lilly.com ↗
In the Phase II study, known as GBCJ, LY2189265 was significantly superior to placebo in reducing key measures of glycemic control, including fasting serum glucose and hemoglobin A1C (HbA1C). |
All press releases naming this drug 49 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 119 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dulaglutide | “A Phase 2, 12-Week, Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate Efficacy and Safety of GX-G6 on Glycaemic Control Versus Placebo and Open-Label...” NCT03962010 ↗96“The potential effect of the GLP-1 RA dulaglutide on the pharmacokinetics (PK) of four orally administered drugs and on the pharmacodynamic (PD) effect of warfarin was investigated.” PMID 28357715 ↗ Nov 2017 “Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists” NCT06449235 ↗ “This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin).” NCT04189848 ↗ “The choice of AOMs considered may include metformin, topiramate, liraglutide, dulaglutide, semaglutide, tirzepatide, and empagliflozin.” NCT07027969 ↗ “LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks” NCT01126580 ↗ “Liraglutide: 6 mg/ml Semaglutide: 1.34 mg/ml Dulaglutide: de 0.75 mg ou 1.5 mg” NCT03498001 ↗ “Albiglutide (Tanzeum) or , Dulaglutide (Trulicity)” NCT02846233 ↗ “Dulaglutide, liraglutide, semaglutide” NCT05390892 ↗ “dulaglutide 1.5 mg per week” NCT04135287 ↗ “dulaglutide (Trulicity)” NCT07325435 ↗ |
| Known as | Dulaglutida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108027 ↗ |
| Known as | dulaglutide (Trulicity) | “dulaglutide (Trulicity)” NCT07325435 ↗ |
| Known as | Dulaglutide component of trulicity | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108027 ↗ |
| Known as | dulaglutide injection | “Drug: dulaglutide injection” NCT06331286 ↗1“Drug: Dulaglutide Injection” NCT06182891 ↗ |
| Known as | LY2189265 | “A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus” NCT02597049 ↗ |
| Known as | Trulicity | “Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via Pen s.c. once weekly for 3 weeks.” NCT03141632 ↗1“dulaglutide (TRULICITY®) 1.5 mg” NCT03648554 ↗ |
| Action | Activate | “once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist” PMID 24762094 ↗ May 2014 |
| Modality | Peptide | “a synthetic once-weekly, injectable human glucagon-like peptide 1 analogue” PMID 28573765 ↗ Jul 2017 |
| Route | Subcutaneous | “subcutaneous (SC) injection” NCT00630825 ↗ |
| Target | GLP1R | “injectable GLP-1RA dulaglutide 0.75 mg” PMID 33460016 ↗ Jan 2021 |