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NCT06037252Active, not recruitingPhase 2

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
414 (actual)
First submitted
8 Sept 2023
Start date
21 Sept 2023
Primary completion date
8 Jan 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT06037252
EU CT number
2023-504561-24-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 414
  • From 21 Sept 2023 to the primary completion date, 8 Jan 2026
  • 40 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
  • Have a prior or planned surgical treatment for obesity.
  • Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
  • Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
    • acute myocardial infarction.
    • cerebrovascular accident (stroke).
    • unstable angina .
    • hospitalization due to congestive heart failure, or
    • coronary artery revascularization.

Other illness

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
  • Have a history of chronic or acute pancreatitis.

Lab values

  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m².

Who the study is looking for

  • Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
  • Have had stable body weight (±5%) during the 90 days preceding screening.
  • Have been diagnosed with Type 2 Diabetes (T2D).
  • Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaUnknown status
Centro Médico Viamonte
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Buenos AiresArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaUnknown status
CEDIC
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CABAArgentinaUnknown status
Consultorio de Investigación Clínica EMO SRL
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
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Ciudad MaderoMexicoUnknown status
Cryptex Investigación Clínica S.A. de C.V.
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Cuauhtémoc, Ciudad de MéxicoMexicoUnknown status
Virgen Cardiovascular Research SC
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GuadalajaraMexicoUnknown status
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
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Mexico CityMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Centro de Investigacion Cardiovascular y Metabólica
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TijuanaMexicoUnknown status
Care Access - Aurora
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AuroraUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Charlottesville Medical Research
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CharlottesvilleUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Velocity Clinical Research, Mt. Auburn
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CincinnatiUnited StatesUnknown status
John Muir Physician Network Research Center
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ConcordUnited StatesUnknown status
Qualmedica Research, LLC
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EvansvilleUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
Retreat Medical Research
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MiamiUnited StatesUnknown status
Clinical Research Associates, Inc.
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NashvilleUnited StatesUnknown status
Alta Pharmaceutical Research Center
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NorcrossUnited StatesUnknown status
American Research Centers of Florida
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Pembroke PinesUnited StatesUnknown status
Medical Advancement Centers of Arizona
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PhoenixUnited StatesUnknown status
Summit Headlands
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PortlandUnited StatesUnknown status
Care Access - Sacramento
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SacramentoUnited StatesUnknown status
AGILE Clinical Research Trials, LLC
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Sandy SpringsUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status
Integrated Clinical Trial Services, Inc.
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West Des MoinesUnited StatesUnknown status
Accellacare - Wilmington - 1917 Tradd Court
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WilmingtonUnited StatesUnknown status
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
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AdanaTurkey (Türkiye)Unknown status
Akdeniz Universitesi Hastanesi
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AntalyaTurkey (Türkiye)Unknown status
Uludag Universitesi
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BursaTurkey (Türkiye)Unknown status
Dicle Üniversitesi
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DiyarbakırTurkey (Türkiye)Unknown status
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
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GaziantepTurkey (Türkiye)Unknown status
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Acibadem Universitesi Atakent Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
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KadıköyTurkey (Türkiye)Unknown status
Ondokuz Mayıs Universitesi
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SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.