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Type 2 DiabetesPhase 3SURMOUNT-2NCT04657003

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

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes and Overweight, run by Eli Lilly and Company at 75 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Overweight, Obesity
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
938 participants
Where
75 sitesin 8 countries
Study dates
29 Mar 2021to 10 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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
Show all 10Show fewer
  • 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

Trial locations and contacts

75 sites in 8 countries.

75 sites in 8 countries

United States43 sites

  • Emory University School of Medicine- Grady Campus

    Atlanta, Georgia, 30303

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78749

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • University of Alabama - Department of Nutrition Sciences

    Birmingham, Alabama, 35294

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Velocity Clinical Research, Cleveland

    Cleveland, Ohio, 44122

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • Aventiv Research

    Dublin, Ohio, 43016

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Northeast Research Institute (NERI)

    Fleming Island, Florida, 32003

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana, 46140

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96813

  • Juno Research

    Houston, Texas, 77040

  • Endocrine Ips, Pllc

    Houston, Texas, 77079

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Logan Health Research

    Kalispell, Montana, 59901

  • Clinical Investigation Specialists

    Kenosha, Wisconsin, 53144

  • KLR Business Group, Inc. dba Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • East Coast Institute for Research, LLC

    Macon, Georgia, 31210

  • New Horizon Research Center

    Miami, Florida, 33165

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Premier Research

    Trenton, New Jersey, 08611

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Center for Neurosciences

    Warwick, Rhode Island, 02886

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Wake Forest University Baptist Medical Center (WFUBMC)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Argentina8 sites

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma de Buenos Aire, C1120AAC

  • CIPREC

    CABA, Ciudad Autónoma de Buenos Aire, C1061AAS

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405BUB

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

  • Go Centro Medico San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, 2900

  • Sanatorio Norte

    Santiago del Estero, 4200

Other trials in Argentina

Brazil6 sites

  • Loema Instituto de Pesquisa Clinica

    Campinas, São Paulo, 13010-001

  • Instituto de Pesquisa clinica de Campinas

    Campinas, São Paulo, 13060-080

  • Private Practice - Dr.Miguel N. Hissa

    Fortaleza, Ceará, 60430-350

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201130

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

Other trials in Brazil

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua County, Changhua, 50006

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 407

  • Chi Mei Medical Center

    Tainan, Tainan, 71004

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

Other trials in Taiwan

Japan4 sites

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo, 143-0015

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004

Other trials in Japan

Russia4 sites

  • Endocrinology Research Center of Rosmedtechnologies

    Moscow, Moscow, 117036

  • Russian Medical Academy of Postgraduate Education

    Moscow, Moscow, 125284

  • Saint-Petersburg City Hospital of Saint Elizabeth

    Saint Petersburg, Sankt-Pete, 195257

  • Smolensk State Medical University

    Smolensk, 214019

Other trials in Russia

Puerto Rico3 sites

  • Centro de Endocrinologia y Nutricion

    Caguas, 00725

  • Latin Clinical Trial Center

    San Juan, 00909

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 917

Other trials in Puerto Rico

India2 sites

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • ILS Hospitals

    Kolkata, West Bengal, 700064

Other trials in India

About this study

Official 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)

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).

Being tested
Tirzepatide, Placebo
Keywords
Metabolism and Nutrition Disorder
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboOther

    Administered SC

Study groups in NCT04657003
Study groupRoleWhat they receive
10 milligrams (mg) TirzepatideExperimental10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)
Receives: Drug: Tirzepatide
15 mg TirzepatideExperimental15 mg Tirzepatide administered SC QW
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorPlacebo administered SC QW
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 72

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline

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

    Measured: Week 72

Secondary outcomes (24)

  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline

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

    Measured: Week 72

  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline

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

    Measured: Week 72

  3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline

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

    Measured: Week 72

  4. Change From Baseline in Absolute Body Weight

    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).

    Measured: Baseline, Week 72

  5. Change From Baseline in Body Mass Index (BMI)

    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).

    Measured: Baseline, Week 72

  6. Change From Baseline in Hemoglobin A1c (HbA1c)

    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).

    Measured: Baseline, Week 72

  7. Percentage of Participants Who Achieve HbA1c <7%

    Percentage of participants who achieve HbA1c <7%

    Measured: Week 72

  8. Percentage of Participants Who Achieve HbA1c ≤6.5%

    Percentage of participants who achieve HbA1c ≤6.5%

    Measured: Week 72

  9. Percentage of Participants Who Achieve HbA1c <5.7%

    Percentage of participants who achieve HbA1c <5.7%

    Measured: Week 72

  10. Change From Baseline in Fasting Glucose

    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).

    Measured: Baseline, Week 72

  11. Change From Baseline in Waist Circumference

    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).

    Measured: Baseline, Week 72

  12. Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  13. Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  14. Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  15. Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  16. Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  17. Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  18. Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  19. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    LSMean was 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).

    Measured: Baseline, Week 72

  20. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    LSMean was 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).

    Measured: Baseline, Week 72

  21. Percent Change From Baseline in Fasting Insulin

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

    Measured: Baseline, Week 72

  22. Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

    Measured: Baseline, Week 72

  23. Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

    Measured: Baseline, Week 72

  24. Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

    Each participant was assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose. The steady state AUC was evaluated using Population PK modeling.

    Measured: Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start29 Mar 2021
  3. Primary completion16 Mar 2023
  4. Study completion10 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
938 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657003
Sponsor's protocol ID
17245
Other IDs
I8F-MC-GPHL
Acronym
SURMOUNT-2
Status last verified
Mar 2024
First submitted
1 Dec 2020
Last updated
8 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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 42348366

  • 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 41537305

  • 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 40512543

  • 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 40120035

  • 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 37385275

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes and Overweight, run by Eli Lilly and Company at 75 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Argentina, Brazil, Taiwan, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight (time frame: Baseline, Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657003, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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