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Clinical Trial Details

Trial ID: L5649
Source ID: NCT06037252
Associated Drug: Tirzepatide
Title: A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Obesity
Interventions: DRUG: Tirzepatide|DRUG: Placebo
Outcome Measures: Primary: Percent Change From Baseline in Body Weight, Baseline (Week 0), Week 44 | Secondary: Change from Baseline in HbA1c, Baseline (Week 0), Week 44|Change from Baseline in HbA1c, Baseline (Week 24), Week 80|Percent Change from Baseline in Body Weight, Baseline (Week 24), Week 80|Absolute Change from Baseline in Body Weight, Baseline (Week 0), Week 44|Absolute Change from Baseline in Body Weight, Baseline (Week 24), Week 80|Change from Baseline in Body Mass Index (BMI), Baseline (Week 0), Week 44|Change from Baseline in BMI, Baseline (Week 24), Week 80|Change from Baseline in Waist Circumference, Baseline (Week 0), Week 44|Change from Baseline in Waist Circumference, Baseline (Week 24), Week 80|Percentage of Participants Achieving ≥15% Body Weight Reduction, Baseline (Week 0), Week 44|Percentage of Participants Achieving ≥15% Body Weight Reduction, Baseline (Week 0), Week 80|Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC), Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame., Baseline through Week 44
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 350
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-21
Completion Date: 2026-10
Results First Posted:
Last Update Posted: 2025-02-28
Locations: Medical Advancement Centers of Arizona, Tempe, Arizona, 85283, United States|John Muir Physician Network Research Center, Concord, California, 94520, United States|Care Access - Sacramento, Sacramento, California, 95831, United States|Care Access - Aurora, Aurora, Colorado, 80012, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Retreat Medical Research, Miami, Florida, 33135, United States|American Research Centers of Florida, Pembroke Pines, Florida, 33027, United States|Alta Pharmaceutical Research Center, Norcross, Georgia, 30092, United States|AGILE Clinical Research Trials, LLC, Sandy Springs, Georgia, 30328, United States|Northwestern University, Chicago, Illinois, 60611, United States|Qualmedica Research, LLC, Evansville, Indiana, 47715, United States|Integrated Clinical Trial Services, Inc., West Des Moines, Iowa, 50265, United States|WellNow Urgent Care and Research - Schenectady, Schenectady, New York, 12304, United States|Accellacare - Wilmington - 1917 Tradd Court, Wilmington, North Carolina, 28401, United States|Velocity Clinical Research, Mt. Auburn, Cincinnati, Ohio, 45219, United States|Summit Headlands, Portland, Oregon, 97210, United States|Clinical Research Associates Inc, Nashville, Tennessee, 37203, United States|Juno Research, Houston, Texas, 77040, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Charlottesville Medical Research, Charlottesville, Virginia, 22911, United States|Northwest Clinical Research Center, Bellevue, Washington, 98007, United States|CEDIC, Caba, Buenos Aires, C1060ABN, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aires, Buenos Aires, 1405, Argentina|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1120AAC, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, C1425AGC, Argentina|Centro de Investigacion Cardiovascular y Metabólica, Tijuana, Baja California, 22500, Mexico|Cryptex Investigación Clínica S.A. de C.V., Cuauhtémoc, Ciudad De México, Distrito Federal, 06100, Mexico|Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Distrito Federal, 11650, Mexico|Virgen Cardiovascular Research SC, Guadalajara, Jalisco, 44670, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, Ciudad Madero, Tamaulipas, 89440, Mexico|TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Kadikoy, İstanbul, 34722, Turkey|Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi, Adana, 01250, Turkey|Akdeniz Universitesi Hastanesi, Antalya, 07070, Turkey|Uludag Universitesi, Bursa, 16059, Turkey|Dicle Üniversitesi, Diyarbakir, 21100, Turkey|Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi, Gaziantep, 27310, Turkey|Acibadem Universitesi Atakent Hastanesi, Istanbul, 34303, Turkey|Seyrantepe Hamidiye Etfal Eğitim ve Araştirma Hastanesi, Istanbul, 34396, Turkey|Marmara Universitesi Pendik Egitim Arastirma Hastanesi, Istanbul, 34899, Turkey|Ondokuz Mayıs Universitesi, Samsun, 55139, Turkey
URL: https://clinicaltrials.gov/show/NCT06037252