Clinical trials›Type 2 Diabetes›Lifestyle›Trial details
FinishedComing Soon (1–3 yrs) Treatment Study

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

For Condition: Type 2 DiabetesFor Condition: OverweightFor Condition: Obesity

ID: NCT04657003

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Study Timeline & Quick Facts
Trial Status
Study Finished
Total Target Enrollment
938 patients (Actual)
Study Start Date
2021-03-29
Est. Primary Completion
2023-03-16
Tested Drugs & Treatment Groups
DRUGTirzepatide (Mounjaro / Zepbound)

Administered SC

OTHERPlacebo

Administered SC

Treatment Arms Description

EXPERIMENTAL10 milligrams (mg) Tirzepatide

10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)

EXPERIMENTAL15 mg Tirzepatide

15 mg Tirzepatide administered SC QW

PLACEBO_COMPARATORPlacebo

Placebo administered SC QW

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can Join
  • Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
  • Have a BMI of ≥27 kg/m²
  • Are overweight or have obesity
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
  • Are at least 18 years of age and age of majority per local laws and regulations
Who Cannot Join
  • Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
  • Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
  • Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
  • Have self-reported change in body weight \>5kg within 3 months prior to screening
  • Have had a history of chronic or acute pancreatitis
  • Change in body weight greater than 5 kg within 3 months prior to starting study
  • Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
  • Any lifetime history of a suicide attempt
What is this Study Measuring?

Primary Outcome Measures

  • Percent Change From Baseline in Body Weight — Time Frame: Baseline, Week 72

    Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  • Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline — Time Frame: Week 72

    Percentage of participants who achieve ≥5% body weight reduction from baseline

View Secondary Outcome Measures (24)
  • Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline — Time Frame: Week 72

    Percentage of participants who achieve ≥10% body weight reduction from baseline

  • Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline — Time Frame: Week 72

    Percentage of participants who achieve ≥15% body weight reduction from baseline

  • Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline — Time Frame: Week 72

    Percentage of participants who achieve ≥20% body weight reduction from baseline

  • Change From Baseline in Absolute Body Weight — Time Frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  • Change From Baseline in Body Mass Index (BMI) — Time Frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  • Change From Baseline in Hemoglobin A1c (HbA1c) — Time Frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  • Percentage of Participants Who Achieve HbA1c <7% — Time Frame: Week 72

    Percentage of participants who achieve HbA1c \<7%

  • Percentage of Participants Who Achieve HbA1c ≤6.5% — Time Frame: Week 72

    Percentage of participants who achieve HbA1c ≤6.5%

  • Percentage of Participants Who Achieve HbA1c <5.7% — Time Frame: Week 72

    Percentage of participants who achieve HbA1c \<5.7%

  • Change From Baseline in Fasting Glucose — Time Frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Where to Participate

This trial is recruiting at 75 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 75 Facilities & Contact Sites
University of Alabama - Department of Nutrition Sciences
Birmingham, Alabama, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, United States
East Coast Institute for Research, LLC
Macon, Georgia, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Logan Health Research
Kalispell, Montana, United States
Premier Research
Trenton, New Jersey, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, United States
Aventiv Research
Dublin, Ohio, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Center for Neurosciences
Warwick, Rhode Island, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Juno Research
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Clinical Investigation Specialists
Kenosha, Wisconsin, United States
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
CIPREC
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina
Sanatorio Norte
Santiago del Estero, Argentina
Private Practice - Dr.Miguel N. Hissa
Fortaleza, Ceará, Brazil
Loema Instituto de Pesquisa Clinica
Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, Brazil
CPCLIN
São Paulo, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil
Life Care Hospital and Research Centre
Bangalore, Karnataka, India
ILS Hospitals
Kolkata, West Bengal, India
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, Japan
AMC Nishiumeda Clinic
Osaka, Japan
Centro de Endocrinologia y Nutricion
Caguas, Puerto Rico
Latin Clinical Trial Center
San Juan, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico
Endocrinology Research Center of Rosmedtechnologies
Moscow, Moscow, Russia
Russian Medical Academy of Postgraduate Education
Moscow, Moscow, Russia
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, Sankt-Pete, Russia
Smolensk State Medical University
Smolensk, Russia
Changhua Christian Hospital
Changhua County, Changhua, Taiwan
Chi Mei Medical Center
Tainan, Tainan, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, Taiwan
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
double (participant, investigator)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Eli Lilly and Company
Clinical Trial Application Copilot

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Scientific Literature & Publications
  • Kokkinos A, Thethi T, Lee CJ, Neff LM, Stefanski A, Cao D, Rodriguez A, Bartee A. Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials. Diabetes Obes Metab. 2026 Sep;28(9):8367-8377. doi: 10.1111/dom.71009. Epub 2026 Jun 25.PubMed ↗
  • Wadden TA, Oquendo MA, Kushner RF, Cao D, Karanikas CA, Kechter A, Murphy MA. Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Obesity (Silver Spring). 2026 Mar;34(3):565-578. doi: 10.1002/oby.70122. Epub 2026 Jan 15.PubMed ↗
  • Heerspink HJL, Friedman AN, Bjornstad P, van Raalte DH, Cherney D, Cao D, Garcia-Perez LE, Stefanski A, Turfanda I, Bunck MC, Benabbad I, Griffin R, Piras de Oliveira C. Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. J Am Soc Nephrol. 2025 Nov 1;36(11):2190-2200. doi: 10.1681/ASN.0000000764. Epub 2025 Jun 13.PubMed ↗
  • Hunter Gibble T, Cao D, Zhang XM, Xavier NA, Poon JL, Fitch A. Tirzepatide Was Associated with Improved Health-Related Quality of Life in Adults with Obesity or Overweight and Type 2 Diabetes: Results from the Phase 3 SURMOUNT-2 Trial. Diabetes Ther. 2025 May;16(5):977-991. doi: 10.1007/s13300-025-01723-w. Epub 2025 Mar 22.PubMed ↗
  • Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26.PubMed ↗
View Official Medical/Scientific Title

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)