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

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Placebo

Tirzepatide

Clinical Study ID

NCT06037252
18739
2023-504561-24-00
I8F-MC-GPIT
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • 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 precedingscreening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, orany other types of diabetes except T2D.

  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode ofhypoglycemia unawareness within 6 months prior to screening.

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/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 renal impairment measured as estimated glomerular filtration rate (eGFR) <45milliliter/min (mL/min)/1.73 m².

  • Have any of the following cardiovascular (CV) conditions within 2 months prior toscreening.

  • acute myocardial infarction.

  • cerebrovascular accident (stroke).

  • unstable angina .

  • hospitalization due to congestive heart failure, or

  • coronary artery revascularization.

  • Have a family or personal history of medullary thyroid carcinoma or multipleendocrine neoplasia (MEN) syndrome Type 2.

  • Have a history of chronic or acute pancreatitis.

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 21, 2023
Estimated Completion Date:
October 31, 2026

Study Description

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Connect with a study center

  • CEDIC

    Caba, Buenos Aires C1060ABN
    Argentina

    Site Not Available

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1405
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires 1056
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire C1425AGC
    Argentina

    Site Not Available

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire 1405
    Argentina

    Active - Recruiting

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • Praktik Velim s.r.o

    Velim, Kolín 281 01
    Czechia

    Site Not Available

  • MUDr. Tomas Edelsberger

    Krnov, Moravskoslezský Kraj 79401
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Praha, Praha 4 14900
    Czechia

    Site Not Available

  • ResTrial s.r.o.

    Praha, Praha 8 18100
    Czechia

    Active - Recruiting

  • FLEDIP s.r.o.

    Prague, Praha, Hlavní Mešto 160 00
    Czechia

    Site Not Available

  • Diacentrum Brandys n.L. s.r.o.

    Brandys nad Labem, Praha-vých 25001
    Czechia

    Site Not Available

  • MUDr. Vladimira Fleischmannova, s.r.o.

    Kolín, Středočeský Kraj 280 02
    Czechia

    Site Not Available

  • Diahaza s.r.o.

    Holesov, Zlínský Kraj 769 01
    Czechia

    Site Not Available

  • Diabetologie a Podiatrie

    Mladá Boleslav, 293 01
    Czechia

    Site Not Available

  • Klinika Dr. Pirka

    Mladá Boleslav, 293 01
    Czechia

    Site Not Available

  • Praglandia s.r.o

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, HaMerkaz 4630945
    Israel

    Site Not Available

  • Edith Wolfson Medical Center

    Holon, HaMerkaz 5810001
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Clalit Health Services - Atlit

    Atlit, HaTsafon 3032343
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, HaTsafon 3339419
    Israel

    Site Not Available

  • Galilee Medical Center

    Nahariya, HaTsafon 2210001
    Israel

    Site Not Available

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, HaTsafon 3081000
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, Ḥeifā 3109601
    Israel

    Site Not Available

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, Baja California 22500
    Mexico

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Distrito Federal 06100
    Mexico

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Completed

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Distrito Federal 11650
    Mexico

    Site Not Available

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Endocrinology

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • Subinvestigation

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • IN-DIA

    Lučenec, Banskobystrický Kraj 984 01
    Slovakia

    Site Not Available

  • Fakultná nemocnica Nitra

    Nitra, Nitriansky Kraj 950 01
    Slovakia

    Site Not Available

  • FUNKYSTUFF s.r.o.

    Nove Zamky, Nitriansky Kraj 940 02
    Slovakia

    Site Not Available

  • Funkystuff

    Nove Zamky, Nitriansky Kraj 940 02
    Slovakia

    Site Not Available

  • Diabetol

    Prešov, Prešovský Kraj 080 01
    Slovakia

    Site Not Available

  • ENDIAMED s.r.o

    Dolny Kubin, Žilinský Kraj 026 01
    Slovakia

    Site Not Available

  • NEDÚ - Národný endokrinologický a diabetologický ústav n.o.

    Lubochna, Žilinský Kraj 034 91
    Slovakia

    Site Not Available

  • IRIDIA

    Vrutky, Žilinský Kraj 038 61
    Slovakia

    Site Not Available

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Kadikoy, İstanbul 34722
    Turkey

    Site Not Available

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250
    Turkey

    Site Not Available

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070
    Turkey

    Site Not Available

  • Uludag Universitesi

    Bursa, 16059
    Turkey

    Completed

  • Dicle Üniversitesi

    Diyarbakir, 21100
    Turkey

    Site Not Available

  • Dicle Üniversitesi

    Diyarbakır, 21100
    Turkey

    Site Not Available

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, 34303
    Turkey

    Completed

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34899
    Turkey

    Site Not Available

  • Seyrantepe Hamidiye Etfal Eğitim ve Araştirma Hastanesi

    Istanbul, 34396
    Turkey

    Active - Recruiting

  • Ondokuz Mayıs Universitesi

    Samsun, 55139
    Turkey

    Site Not Available

  • St Clare Medical Centre

    Penzance, Cornwall TR18 3DX
    United Kingdom

    Site Not Available

  • Rowden Surgery

    Chippenham, England SN15 2SB
    United Kingdom

    Site Not Available

  • Abbeywell Surgery

    Romsey, England SO51 7QN
    United Kingdom

    Site Not Available

  • Hammersmith and Fulham Partnership Research Unit

    London, Hammersmith And Fulham W6 7HY
    United Kingdom

    Site Not Available

  • Layton Medical Centre

    Blackpool, Lancashire FY3 7EN
    United Kingdom

    Site Not Available

  • Windrush Medical Practice

    Witney, Oxfordshire OX28 6JS
    United Kingdom

    Site Not Available

  • Cheadle Community Hospital

    Cheadle, Staffordshire ST10 1NS
    United Kingdom

    Site Not Available

  • Medical Advancement Centers of Arizona

    Tempe, Arizona 85283
    United States

    Site Not Available

  • John Muir Physician Network Research Center

    Concord, California 94520
    United States

    Site Not Available

  • Care Access - Sacramento

    Sacramento, California 95831
    United States

    Site Not Available

  • Care Access - Aurora

    Aurora, Colorado 80012
    United States

    Completed

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Retreat Medical Research

    Miami, Florida 33135
    United States

    Site Not Available

  • American Research Centers of Florida

    Pembroke Pines, Florida 33027
    United States

    Site Not Available

  • Alta Pharmaceutical Research Center

    Norcross, Georgia 30092
    United States

    Site Not Available

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia 30092
    United States

    Site Not Available

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa 50265
    United States

    Completed

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • WellNow Urgent Care and Research - Schenectady

    Schenectady, New York 12304
    United States

    Active - Recruiting

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Completed

  • Summit Headlands

    Portland, Oregon 97210
    United States

    Site Not Available

  • Clinical Research Associates Inc

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Completed

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

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