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

Phase 2

Recruiting

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06037252
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-14
• Study Start: 2023-09-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-01
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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

• 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.

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Participants will receive tirzepatide SC.
Placebo	Placebo	Participants will receive placebo.
Tirzepatide High Dose 1	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC).
Tirzepatide High Dose 2	Tirzepatide	Participants will receive tirzepatide SC.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight	Baseline (Week 0), Week 44

Secondary Outcome Measures

Name	Time	Method
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
Percentage of Participants Achieving ≥15% Body Weight Reduction	Baseline (Week 0), Week 80
Change from Baseline in HbA1c	Baseline (Week 24), Week 80
Percent Change from Baseline in Body Weight	Baseline (Week 24), Week 80
Change from Baseline in BMI	Baseline (Week 24), Week 80
Change from Baseline in Waist Circumference	Baseline (Week 24), Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	Baseline through Week 44	Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.

Trial Locations

Locations (42)

Medical Advancement Centers of Arizona; 🇺🇸 Tempe, Arizona, United States

John Muir Physician Network Research Center; 🇺🇸 Concord, California, United States

Care Access - Sacramento; 🇺🇸 Sacramento, California, United States

Care Access - Aurora; 🇺🇸 Aurora, Colorado, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

Retreat Medical Research; 🇺🇸 Miami, Florida, United States

American Research Centers of Florida; 🇺🇸 Pembroke Pines, Florida, United States

Alta Pharmaceutical Research Center; 🇺🇸 Norcross, Georgia, United States

AGILE Clinical Research Trials, LLC; 🇺🇸 Sandy Springs, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Qualmedica Research, LLC; 🇺🇸 Evansville, Indiana, United States

Integrated Clinical Trial Services, Inc.; 🇺🇸 West Des Moines, Iowa, United States

WellNow Urgent Care and Research - Schenectady; 🇺🇸 Schenectady, New York, United States

Accellacare - Wilmington - 1917 Tradd Court; 🇺🇸 Wilmington, North Carolina, United States

Velocity Clinical Research, Mt. Auburn; 🇺🇸 Cincinnati, Ohio, United States

Summit Headlands; 🇺🇸 Portland, Oregon, United States

Clinical Research Associates Inc; 🇺🇸 Nashville, Tennessee, United States

Juno Research; 🇺🇸 Houston, Texas, United States

Southern Endocrinology Associates; 🇺🇸 Mesquite, Texas, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

CEDIC; 🇦🇷 Caba, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Centro Médico Viamonte; 🇦🇷 Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada; 🇦🇷 Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro de Investigacion Cardiovascular y Metabólica; 🇲🇽 Tijuana, Baja California, Mexico

Cryptex Investigación Clínica S.A. de C.V.; 🇲🇽 Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares; 🇲🇽 Mexico City, Distrito Federal, Mexico

Virgen Cardiovascular Research SC; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"; 🇲🇽 Monterrey, Nuevo León, Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares; 🇲🇽 Ciudad Madero, Tamaulipas, Mexico

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi; 🇹🇷 Kadikoy, İstanbul, Turkey

Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi; 🇹🇷 Adana, Turkey

Akdeniz Universitesi Hastanesi; 🇹🇷 Antalya, Turkey

Uludag Universitesi; 🇹🇷 Bursa, Turkey

Dicle Üniversitesi; 🇹🇷 Diyarbakir, Turkey

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi; 🇹🇷 Gaziantep, Turkey

Acibadem Universitesi Atakent Hastanesi; 🇹🇷 Istanbul, Turkey

Seyrantepe Hamidiye Etfal Eğitim ve Araştirma Hastanesi; 🇹🇷 Istanbul, Turkey

Marmara Universitesi Pendik Egitim Arastirma Hastanesi; 🇹🇷 Istanbul, Turkey

Ondokuz Mayıs Universitesi; 🇹🇷 Samsun, Turkey