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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 414
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1056ABI
    • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1060ABN
      • CEDIC
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1405
      • Consultorio de Investigacion Clinica EMO SRL
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
      • Centro Médico Viamonte
    • Buenos Aires, Buenos Aires F.D., Argentina, C1425AGC
      • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
• Mexico
  • Estado de Baja California
    • Tijuana, Estado de Baja California, Mexico, 22500
      • Centro de Investigacion Cardiovascular y Metabolica
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Virgen Cardiovascular Research SC
  • Mexico City
    • Cuauhtémoc, Ciudad de México, Mexico City, Mexico, 06100
      • Cryptex Investigación Clínica S.A. de C.V.
    • Mexico City, Mexico City, Mexico, 11650
      • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Tamaulipas
    • Ciudad Madero, Tamaulipas, Mexico, 89440
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
  • Antalya, Turkey (Türkiye), 07070
    • Akdeniz Universitesi Hastanesi
  • Bursa, Turkey (Türkiye), 16059
    • Uludag Universitesi
  • Diyarbakır, Turkey (Türkiye), 21100
    • Dicle Üniversitesi
  • Gaziantep, Turkey (Türkiye), 27310
    • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
  • Istanbul, Turkey (Türkiye), 34303
    • Acibadem Universitesi Atakent Hastanesi
  • Istanbul, Turkey (Türkiye), 34899
    • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayıs Universitesi
  • Istanbul
    • Kadıköy, Istanbul, Turkey (Türkiye), 34722
      • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • Medical Advancement Centers of Arizona
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Research Center
    • Sacramento, California, United States, 95831
      • Care Access - Sacramento
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Care Access - Aurora
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Miami, Florida, United States, 33135
      • Retreat Medical Research
    • Pembroke Pines, Florida, United States, 33027
      • American Research Centers of Florida
  • Georgia
    • Norcross, Georgia, United States, 30092
      • Alta Pharmaceutical Research Center
    • Sandy Springs, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington - 1917 Tradd Court
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Velocity Clinical Research, Mt. Auburn
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Headlands
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Houston, Texas, United States, 77040
      • Juno Research
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo.	Drug: Placebo; Administered SC
Experimental: Tirzepatide High Dose 1; Participants will receive tirzepatide subcutaneously (SC).	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: Tirzepatide High Dose 2; Participants will receive tirzepatide SC.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Active Comparator: Tirzepatide; Participants will receive tirzepatide SC.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight	Baseline (Week 0), Week 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): January 8, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Body Weight; Metabolic Disease; Glucose Metabolism Disorders; Endocrine System Diseases; Nutrition Disorders; Incretins; Overnutrition; Tirzepatide
• Additional Relevant MeSH Terms: Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Body Weight; Diabetes Mellitus; Metabolic Diseases; Nutrition Disorders; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 18739; I8F-MC-GPIT (Other Identifier: Eli Lilly and Company); 2023-504561-24-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No