Clincosm LogoSign in Get a demo

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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04657003
Collaborator
(none)
900
Enrollment
75
Locations
3
Arms
24.6
Anticipated Duration (Months)
12
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Mar 20, 2023
Anticipated Study Completion Date :
Apr 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10 mg Tirzepatide

10 mg Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: 15 mg Tirzepatide

    15 mg Tirzepatide administered SC

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Placebo administered SC

    Other: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Randomization in Body Weight [Randomization, 72 Weeks]

      Percent Change from randomization in body weight

    2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization [72 Weeks]

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

    Secondary Outcome Measures

    1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization [72 Weeks]

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

    2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline [72 Weeks]

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

    3. Change from Randomization in Absolute Body Weight [Randomization, 72 Weeks]

      Change from randomization in absolute body weight

    4. Change from Randomization in Body Mass Index (BMI) [Randomization, 72 Weeks]

      Change from randomization in BMI

    5. Change from Randomization in HbA1c [Randomization, 72 Weeks]

      Change from randomization in HbA1c

    6. Percentage of Participants who Achieve HbA1c <7% [72 Weeks]

      Percentage of Participants who Achieve HbA1c <7%

    7. Percentage of Participants Who Achieve HbA1c ≤6.5% [72 Weeks]

      Percentage of participants who achieve HbA1c ≤6.5%

    8. Percentage of Participants Who Achieve HbA1c <5.7% [72 Weeks]

      Percentage of participants who achieve HbA1c <5.7%

    9. Change from Randomization in Fasting Glucose [Randomization, 72 Weeks]

      Change from randomization in fasting glucose

    10. Change from Randomization in Waist Circumference [Randomization, 72 Weeks]

      Change from randomization in waist circumference

    11. Change from Randomization in Total Cholesterol [Randomization, 72 Weeks]

      Change from randomization in total cholesterol

    12. Change from Randomization in Low Density Lipid (LDL)-Cholesterol [Randomization, 72 Weeks]

      Change from randomization in LDL-cholesterol

    13. Change from Randomization in High Density Lipid (HDL) Cholesterol [Randomization, 72 Weeks]

      Change from randomization in HDL cholesterol

    14. Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol [Randomization, 72 Weeks]

      Change from randomization in VLDL cholesterol

    15. Change from Randomization in Triglycerides [Randomization, 72 Weeks]

      Change from randomization in triglycerides

    16. Change from Randomization in Free Fatty Acids [Randomization, 72 Weeks]

      Change from randomization in free fatty acids

    17. Change from Randomization in Systolic Blood Pressure (SBP) [Randomization, 72 Weeks]

      Change from randomization in SBP

    18. Change from Randomization in Diastolic Blood Pressure (DBP) [Randomization, 72 Weeks]

      Change from randomization in DBP

    19. Change from Randomization in Fasting Insulin [Randomization, 72 Weeks]

      Change from randomization in fasting insulin

    20. Change from Randomization in Short Form 36 Health Survey version 2 (SF-36v2) acute form Physical Functioning domain score [Randomization, 72 Weeks]

      The Short Form 36 Version 2 (SF-36v2 ) acute form, 1-week recall, assesses participants' health-related quality of life (HRQoL) on 8 domains: 1) limitations in physical functioning; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning; 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health.

    21. Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score [Randomization, 72 Weeks]

      The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.

    22. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide [Baseline through Week 72]

      PK: Steady State AUC of Tirzepatide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama - Department of Nutrition Sciences Birmingham Alabama United States 35294
    2 KLR Business Group, Inc. dba Arkansas Clinical Research Little Rock Arkansas United States 72205
    3 Velocity Clinical Research, Huntington Park Huntington Park California United States 90255
    4 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    5 Catalina Research Institute, LLC Montclair California United States 91763
    6 Encompass Clinical Research Spring Valley California United States 91978
    7 University Clinical Investigators, Inc. Tustin California United States 92780
    8 ALL Medical Research, LLC Cooper City Florida United States 33024
    9 Northeast Research Institute (NERI) Fleming Island Florida United States 32003
    10 New Horizon Research Center Miami Florida United States 33165
    11 West Orange Endocrinology Ocoee Florida United States 34761
    12 Metabolic Research Institute, Inc. West Palm Beach Florida United States 33401
    13 Emory University School of Medicine- Grady Campus Atlanta Georgia United States 30303
    14 East Coast Institute for Research, LLC Macon Georgia United States 31210
    15 Pacific Diabetes & Endocrine Center Honolulu Hawaii United States 96813
    16 Elite Clinical Trials Blackfoot Idaho United States 83221
    17 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    18 American Health Network of Indiana, LLC - Greenfield Greenfield Indiana United States 46140
    19 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    20 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    21 Maryland Cardiovascular Specialists Baltimore Maryland United States 21229
    22 MD Medical Research Oxon Hill Maryland United States 20745
    23 NECCR PrimaCare Research Fall River Massachusetts United States 02721
    24 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
    25 Logan Health Research Kalispell Montana United States 59901
    26 Premier Research Trenton New Jersey United States 08611
    27 University of North Carolina Medical Center Chapel Hill North Carolina United States 27514
    28 PharmQuest Greensboro North Carolina United States 27408
    29 Wake Forest University Baptist Medical Center (WFUBMC) Winston-Salem North Carolina United States 27157
    30 Velocity Clinical Research, Cleveland Cleveland Ohio United States 44122
    31 Aventiv Research Dublin Ohio United States 43016
    32 The Corvallis Clinic, P.C. Corvallis Oregon United States 97330
    33 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
    34 Center for Neurosciences Warwick Rhode Island United States 02886
    35 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    36 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78749
    37 Dallas Diabetes Research Center Dallas Texas United States 75230
    38 Diabetes and Thyroid Center of Fort Worth Fort Worth Texas United States 76132
    39 Juno Research Houston Texas United States 77040
    40 Endocrine Ips, Pllc Houston Texas United States 77079
    41 Health Research of Hampton Roads, Inc. Newport News Virginia United States 23606
    42 Rainier Clinical Research Center Renton Washington United States 98057
    43 Clinical Investigation Specialists Kenosha Wisconsin United States 53144
    44 Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1405BUB
    45 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
    46 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
    47 Go Centro Medico San Nicolás San Nicolas Buenos Aires Argentina 2900
    48 Centro Médico Viamonte Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1120AAC
    49 CIPREC Caba Ciudad Autónoma De Buenos Aire Argentina C1061AAS
    50 Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán Argentina T4000AXL
    51 Sanatorio Norte Santiago del Estero Argentina 4200
    52 Private Practice - Dr.Miguel N. Hissa Fortaleza Ceará Brazil 60430-350
    53 Loema Instituto de Pesquisa Clinica Campinas São Paulo Brazil 13010-001
    54 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
    55 CECIP - Centro de Estudos do Interior Paulista Jaú São Paulo Brazil 17201130
    56 CPCLIN Sao Paulo São Paulo Brazil 01228-200
    57 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    58 Life Care Hospital and Research Centre Bangalore Karnataka India 560092
    59 ILS Hospitals Kolkata West Bengal India 700064
    60 Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic Yamato-shi Kanagawa Japan 242-0004
    61 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    62 Medical Corporation Sato Medical clinic Ootaku Tokyo Japan 143-0015
    63 AMC Nishiumeda Clinic Osaka Japan 530-0001
    64 Centro de Endocrinologia y Nutricion Caguas Puerto Rico 00725
    65 Latin Clinical Trial Center San Juan Puerto Rico 00909
    66 GCM Medical Group, PSC - Hato Rey Site San Juan Puerto Rico 917
    67 Endocrinology Research Center of Rosmedtechnologies Moscow Moskva Russian Federation 117036
    68 Russian Medical Academy of Postgraduate Education Moscow Moskva Russian Federation 125284
    69 Saint-Petersburg City Hospital of Saint Elizabeth Saint Petersburg Sankt-Pete Russian Federation 195257
    70 Smolensk State Medical University Smolensk Russian Federation 214019
    71 Changhua Christian Hospital Changhua County Changhua Taiwan 50006
    72 Chi Mei Medical Center Tainan City Tainan Taiwan 71004
    73 Chung Shan Medical University Hospital Taichung Taiwan 402
    74 Taichung Veterans General Hospital Taichung Taiwan 407
    75 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04657003
    Other Study ID Numbers:
    • 17245
    • I8F-MC-GPHL
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Metabolism and Nutrition Disorder
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Obesity
    Diabetes Mellitus, Type 2
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Apr 19, 2022