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Clinical trials for tirzepatide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44381   clinical trials with a EudraCT protocol, of which   7393   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: tirzepatide. Displaying page 1 of 1.
    EudraCT Number: 2021-003612-31 Sponsor Protocol Number: I8F-MC-GPGV Start Date*: 2022-08-16
    Sponsor Name:ELI LILLY & COMPANY, LILLY CORPORATE CENTER
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adol...
    Medical condition: Type 2 Diabetes Mellitus (T2DM)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002735-28 Sponsor Protocol Number: I8F-MC-GPGN Start Date*: 2020-03-30
    Sponsor Name:Eli Lilly and Company
    Full Title: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) DE (Ongoing) SK (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2024-000081-22 Sponsor Protocol Number: I8F-MC-GPHV Start Date*: 2024-03-07
    Sponsor Name:Eli Lilly and Company
    Full Title: A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 years to 11 years) with Obesity.
    Medical condition: Weight management
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10027428 Metabolic disorders NEC HLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-003853-70 Sponsor Protocol Number: PNRR-MR1-2022-12375914 Start Date*: 2023-05-02
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: Towards a personalized precision medicine in rare disease: tirzepatide (a dual glucose­ dependent insulinotropic polypeptide and glucagon-like peptide-I receptor agonist) monotherapy in patients wi...
    Medical condition: Wolfram syndrome type 1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10078338 Wolfram syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10078338 Wolfram syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10078338 Wolfram syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001550-26 Sponsor Protocol Number: I8F-MC-GPHR Start Date*: 2020-01-23
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)
    Medical condition: Nonalcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) FR (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000284-23 Sponsor Protocol Number: I8F-MC-GPHD Start Date*: 2020-11-03
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly versus Insulin Lispro (U100) Three Times Daily in Participants with Type 2 Diabetes Inadequat...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) SK (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000860-99 Sponsor Protocol Number: I8F-MC-GPGI Start Date*: 2019-08-16
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide versus Placebo in Patients with Type 2 Diabetes Inadequately Controlled on Insulin Glargine with or wit...
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) DE (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005273-47 Sponsor Protocol Number: I8F-MC-GPIG Start Date*: 2022-11-21
    Sponsor Name:Eli Lilly and Company
    Full Title: Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease usin...
    Medical condition: Obesity and Chronic Kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10038359 Renal and urinary disorders SOC
    20.0 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DK (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003422-84 Sponsor Protocol Number: I8F-MC-GPGH Start Date*: 2019-04-05
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 versus Titrated Insulin Degludec on Glycemic Control in Patients with Type 2 Diabetes
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) AT (Completed) HU (Completed) PL (Completed) ES (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-004422-29 Sponsor Protocol Number: I8F-MC-GPGL(b) Start Date*: 2019-07-26
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients with Type 2 Diabetes (SURPASS-2)
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-002618-11 Sponsor Protocol Number: I8F-MC-GPGM Start Date*: 2019-05-06
    Sponsor Name:Eli Lilly and Company
    Full Title: Efficacy and Safety of LY3298176 Once Weekly versus Insulin Glargine in Patients with Type 2 Diabetes and Increased Cardiovascular Risk
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-004552-41 Sponsor Protocol Number: I8F-MC-GPI2 Start Date*: 2022-09-14
    Sponsor Name:Eli Lilly and Company
    Full Title: A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Tria...
    Medical condition: Obstructive sleep apnea
    Disease: Version SOC Term Classification Code Term Level
    25.0 10038738 - Respiratory, thoracic and mediastinal disorders 10029983 Obstructive sleep apnoea syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-004551-16 Sponsor Protocol Number: I8F-MC-GPI1 Start Date*: 2022-09-14
    Sponsor Name:Eli Lilly and Company
    Full Title: A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Tria...
    Medical condition: Obstructive sleep apnea
    Disease: Version SOC Term Classification Code Term Level
    25.0 10038738 - Respiratory, thoracic and mediastinal disorders 10029983 Obstructive sleep apnoea syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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