A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
SURMOUNT-2
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)
2 other identifiers
interventional
938
8 countries
75
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Mar 2021
Typical duration for phase_3 type-2-diabetes
75 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
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2023
CompletedResults Posted
Study results publicly available
April 8, 2024
CompletedApril 8, 2024
March 1, 2024
2 years
December 1, 2020
March 8, 2024
March 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Body Weight
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).
Baseline, Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
Percentage of participants who achieve ≥5% body weight reduction from baseline
Week 72
Secondary Outcomes (24)
Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline
Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline
Week 72
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline
Week 72
Change From Baseline in Absolute Body Weight
Baseline, Week 72
Change From Baseline in Body Mass Index (BMI)
Baseline, Week 72
- +19 more secondary outcomes
Study Arms (3)
10 milligrams (mg) Tirzepatide
EXPERIMENTAL10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)
15 mg Tirzepatide
EXPERIMENTAL15 mg Tirzepatide administered SC QW
Placebo
PLACEBO COMPARATORPlacebo administered SC QW
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
University of Alabama - Department of Nutrition Sciences
Birmingham, Alabama, 35294, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003, United States
New Horizon Research Center
Miami, Florida, 33165, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303, United States
East Coast Institute for Research, LLC
Macon, Georgia, 31210, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, 46140, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Premier Research
Trenton, New Jersey, 08611, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, 27157, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122, United States
Aventiv Research
Dublin, Ohio, 43016, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Center for Neurosciences
Warwick, Rhode Island, 02886, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Juno Research
Houston, Texas, 77040, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144, United States
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BUB, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Go Centro Medico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina
Centro Médico Viamonte
Buenos Aires, Ciudad Autónoma de Buenos Aire, C1120AAC, Argentina
CIPREC
CABA, Ciudad Autónoma de Buenos Aire, C1061AAS, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Sanatorio Norte
Santiago del Estero, 4200, Argentina
Private Practice - Dr.Miguel N. Hissa
Fortaleza, Ceará, 60430-350, Brazil
Loema Instituto de Pesquisa Clinica
Campinas, São Paulo, 13010-001, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, 17201130, Brazil
CPCLIN
São Paulo, São Paulo, 01228-200, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Life Care Hospital and Research Centre
Bangalore, Karnataka, 560092, India
ILS Hospitals
Kolkata, West Bengal, 700064, India
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, 242-0004, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853, Japan
Medical Corporation Sato Medical clinic
Ootaku, Tokyo, 143-0015, Japan
AMC Nishiumeda Clinic
Osaka, 530-0001, Japan
Centro de Endocrinologia y Nutricion
Caguas, 00725, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 917, Puerto Rico
Endocrinology Research Center of Rosmedtechnologies
Moscow, Moscow, 117036, Russia
Russian Medical Academy of Postgraduate Education
Moscow, Moscow, 125284, Russia
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, Sankt-Pete, 195257, Russia
Smolensk State Medical University
Smolensk, 214019, Russia
Changhua Christian Hospital
Changhua County, Changhua, 50006, Taiwan
Chi Mei Medical Center
Tainan, Tainan, 71004, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, 704, Taiwan
Related Publications (4)
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 Jan 15. doi: 10.1002/oby.70122. Online ahead of print.
PMID: 41537305DERIVEDHeerspink 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.
PMID: 40512543DERIVEDHunter 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.
PMID: 40120035DERIVEDGarvey 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.
PMID: 37385275DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 7, 2020
Study Start
March 29, 2021
Primary Completion
March 16, 2023
Study Completion
April 10, 2023
Last Updated
April 8, 2024
Results First Posted
April 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Time Frame: Data are available 6 months after the primary publication or 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.