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
3 other identifiers
interventional
414
4 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Sep 2023
Longer than P75 for phase_2 type-2-diabetes
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedStudy Start
First participant enrolled
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedMarch 23, 2026
March 1, 2026
2.3 years
September 8, 2023
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight
Baseline (Week 0), Week 44
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (4)
Tirzepatide High Dose 1
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC).
Tirzepatide High Dose 2
EXPERIMENTALParticipants will receive tirzepatide SC.
Tirzepatide
ACTIVE COMPARATORParticipants will receive tirzepatide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Medical Advancement Centers of Arizona
Phoenix, Arizona, 85044, 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
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 Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, Estado de Baja California, 22500, Mexico
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, 44670, Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650, 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
Kadıköy, Istanbul, 34722, Turkey (Türkiye)
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, 01250, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07070, Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21100, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi
Istanbul, 34303, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Ondokuz Mayıs Universitesi
Samsun, 55139, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 14, 2023
Study Start
September 21, 2023
Primary Completion
January 8, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.