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SURMOUNT-1: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04184622
Collaborator
(none)
2,539
Enrollment
120
Locations
4
Arms
53.7
Anticipated Duration (Months)
21.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2539 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 Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Actual Study Start Date :
Dec 4, 2019
Actual Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5 mg Tirzepatide

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: 10 mg Tirzepatide

    10 mg tirzepatide administered SC once a week.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Experimental: 15 mg Tirzepatide

    15 mg tirzepatide administered SC once a week.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Placebo administered SC once a week.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Body Weight [Baseline, Week 72]

      Percent Change from Baseline in Body Weight

    2. Percentage of Participants who Achieve ≥5% Body Weight Reduction [Week 72]

      Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Secondary Outcome Measures

    1. Change from Baseline in Body Weight [Baseline, Week 20]

      Change from Baseline in Body Weight

    2. Percent Change from Baseline in Body Weight [Baseline, Week 176]

      Percent Change from Baseline in Body Weight

    3. Percentage of Participants who Achieve ≥10% Body Weight Reduction [Week 72]

      Percentage of Participants who Achieve ≥10% Body Weight Reduction

    4. Percentage of Participants who Achieve ≥15% Body Weight Reduction [Week 72]

      Percentage of Participants who Achieve ≥15% Body Weight Reduction

    5. Percentage of Participants who Achieve ≥5% Body Weight Reduction [Week 176]

      Percentage of Participants who Achieve ≥5% Body Weight Reduction

    6. Percentage of Participants who Achieve ≥20% Body Weight Reduction [Week 72]

      Percentage of Participants who Achieve ≥20% Body Weight Reduction

    7. Change from Baseline in Waist Circumference [Baseline, Week 72]

      Change from Baseline in Waist Circumference

    8. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 72]

      Change from Baseline in BMI

    9. Change from Baseline in Fasting Glucose [Baseline, Week 72]

      Change from Baseline in Fasting Glucose

    10. Change from Baseline in Fasting Insulin [Baseline, Week 72]

      Change from Baseline in Fasting Insulin

    11. Time to Onset of Type 2 Diabetes [Baseline through Week 176]

      Time to Onset of Type 2 Diabetes

    12. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 72]

      Change from Baseline in HbA1c

    13. Change from Baseline in Triglycerides [Baseline, Week 72]

      Change from Baseline in Triglycerides

    14. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol [Baseline, Week 72]

      Change from Baseline in LDL Cholesterol

    15. Change from Baseline in Total Cholesterol [Baseline, Week 72]

      Change from Baseline in Total Cholesterol

    16. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol [Baseline, Week 72]

      Change from Baseline in HDL Cholesterol

    17. Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [Baseline, Week 72]

      Change from Baseline in VLDL Cholesterol

    18. Change from Baseline in Free Fatty Acids [Baseline, Week 72]

      Change from Baseline in Free Fatty Acids

    19. Change from Baseline in Systolic Blood Pressure [Baseline, Week 72]

      Change from Baseline in Systolic Blood Pressure

    20. Change from Baseline in Diastolic Blood Pressure [Baseline, Week 72]

      Change from Baseline in Diastolic Blood Pressure

    21. Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [Baseline, Week 72]

      Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score

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

      Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score

    23. Pharmacokinetics (PK): Steady State Area Under the Concentration Time 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:

    • Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease

    • History of at least one unsuccessful dietary effort to lose body weight

    Exclusion Criteria:

    • Diabetes mellitus

    • 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

    • History of pancreatitis

    • 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 Cahaba Research Pelham Alabama United States 35124
    2 Perseverance Research Center Scottsdale Arizona United States 85254
    3 John Muir Physician Network Clinical Research Center Concord California United States 94520
    4 Valley Endocrine, Fresno Fresno California United States 93720
    5 National Research Institute - Huntington Park Los Angeles California United States 90057
    6 Catalina Research Institute, LLC Montclair California United States 91763
    7 Encompass Clinical Research Spring Valley California United States 91978
    8 University Clinical Investigators, Inc. Tustin California United States 92780
    9 CMR of Greater New Haven Hamden Connecticut United States 06517
    10 Yale University School of Medicine New Haven Connecticut United States 06519
    11 Suncoast Research Group Miami Florida United States 33135
    12 New Horizon Research Center Miami Florida United States 33165 3338
    13 Renstar Medical Research Ocala Florida United States 34470
    14 Oviedo Medical Research Oviedo Florida United States 32765
    15 ForCare Clinical Research Tampa Florida United States 33613-1244
    16 United Osteoporosis Center Gainesville Georgia United States 30501
    17 Herman Clinical Research, LLC Suwanee Georgia United States 30024
    18 East-West Medical Research Institute Honolulu Hawaii United States 96814
    19 Midwest Institute for Clinical Research Indianapolis Indiana United States 46260
    20 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    21 Cotton O'Neil Clinic Topeka Kansas United States 66606
    22 L-MARC Research Center Louisville Kentucky United States 40213
    23 NECCR PrimaCare Research Fall River Massachusetts United States 02721
    24 ActivMed Practices and Research Methuen Massachusetts United States 01844
    25 Troy Internal Medicine, PC Troy Michigan United States 48098
    26 Sky Clin Resch - Quinn HC Ridgeland Mississippi United States 39157
    27 StudyMetrix Research Saint Peters Missouri United States 63303
    28 Clinvest Research LLC Springfield Missouri United States 65810
    29 Palm Research Center Tenaya Las Vegas Nevada United States 89148
    30 Premier Research Trenton New Jersey United States 08611
    31 NYU Langone New York New York United States 10016
    32 Weill Cornell Medicine, Comprehensive Weight Control Center New York New York United States 10065
    33 Rochester Clinical Research, Inc. Rochester New York United States 14609
    34 University of North Carolina Diabetes Center Chapel Hill North Carolina United States 27517
    35 PharmQuest Greensboro North Carolina United States 27408
    36 Lillestol Research LLC Fargo North Dakota United States 58104
    37 Rapid Medical Research Cleveland Ohio United States 44122
    38 Aventiv Research Inc Columbus Ohio United States 43213
    39 Intend Research, LLC Norman Oklahoma United States 73069
    40 Summit Research Network Inc Portland Oregon United States 97210
    41 Detweiler Family Medicine & Associates Lansdale Pennsylvania United States 19446
    42 Preferred Primary Care Physicians - Jacob Murphy Lane Uniontown Pennsylvania United States 15401
    43 Omega Medical Research Warwick Rhode Island United States 02886
    44 Medical University of South Carolina Charleston South Carolina United States 29425
    45 Mountain View Clinical Research, Inc. Greer South Carolina United States 29651
    46 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
    47 WR-Clinsearch, LLC Chattanooga Tennessee United States 37421
    48 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78731-4309
    49 Dallas Diabetes Research Center Dallas Texas United States 75230
    50 North Texas Endocrine Center Dallas Texas United States 75231
    51 Research Institute of Dallas Dallas Texas United States 75231
    52 Southern Endocrinology Associates Mesquite Texas United States 75149
    53 Texas Diabetes & Endocrinology, P.A. Round Rock Texas United States 78681
    54 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    55 Stat Research Caba Buenos Aires Argentina C1013AAB
    56 Centro de Investigaciones Metabólicas (CINME) Caba Buenos Aires Argentina C1056ABJ
    57 Centro Médico Viamonte Caba Buenos Aires Argentina C1120AAC
    58 Mautalen Salud e Investigación - Servicio de Endocrinología Caba Buenos Aires Argentina C1128AAF
    59 Consultorio de Investigación Clínica EMO SRL Caba Buenos Aires Argentina C1405BUB
    60 CEDIC Caba Buenos Aires Argentina C1425DES
    61 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
    62 DIM Clinica Privada Ramos Mejía Buenos Aires Argentina 1704
    63 GO Centro Médico San Nicolás San Nicolás Buenos Aires Argentina B2900DPA
    64 Centro Medico Privado de Reumatologia San Miguel De Tucumán Tucumán Argentina T4000AXL
    65 Sanatorio Norte Santiago del Estero Argentina 4200
    66 CEDOES Vitoria ES Brazil 29055-450
    67 Loema - Instituto de Pesquisa Clinica Campinas SP Brazil 13010-001
    68 CPQuali Pesquisa Clínica São Paulo SP Brazil 01228-000
    69 CPCLIN São Paulo SP Brazil 01228-200
    70 CEPIC - Centro Paulista de Investigação Clínica São Paulo SP Brazil 04266-010
    71 Hospital da Clinicas da Faculdade de Medicina da USP São Paulo SP Brazil 05403-000
    72 IPECC - Instituto de Pesquisa Clinica de Campinas Campinas São Paulo Brazil 13060-080
    73 Instituto Brasil de Pesquisa Clínica - IBPCLIN Rio de Janeiro Brazil 20241180
    74 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    75 The Fourth Affiliated Hospital of Harbin Medical University Harbin Nangang District China 150001
    76 Jinan Central Hospital Jinan Shandong China 250013
    77 The First Affiliated Hospital of Xi'an Medical University Xi'an Shanxi China
    78 West China Hospital Sichuan University Chengdu Sichuan China 610041
    79 Ningbo First Hospital Ningbo Zhejiang China 315010
    80 Beijing Tsinghua Changgung Hospital Beijing China 102202
    81 Care Hospital Hyderabad Andhra Pradesh India 500 035
    82 Gujarat Endocrine Center Ahmedabad Gujarat India 380006
    83 Grant Medical College & Sir J.J. Group of Hospitals Mumbai Maharashtra India 400008
    84 Deenanath Mangeshkar Hospital & Research Centre Pune Maharashtra India 411004
    85 ILS Hospital Kolkata West Bengal India 700064
    86 Fortis Hospital Delhi India 110088
    87 OCROM Clinic Suita Osaka Japan 565-0853
    88 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    89 Medical Corporation Chiseikai Tokyo Center Clinic Chuo-ku Tokyo Japan 103-0028
    90 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    91 AMC nishi-umeda clinic Osaka Japan 530-0001
    92 Ctro Inv en Artritis y Osteoporosis SC Mexicali Baja California Mexico 21200
    93 Centro Especializado en Diabetes Obesidad y Enfermedades Mexico D.f. Mexico 11650
    94 Unidad de Investigacion Clinica y Atencion Medica HEPA S.C. Guadalajara Jalisco Mexico 44670
    95 Virgen Cardiovascular Research S.C Guadalajara Jalisco Mexico 44670
    96 Inst. de Diabetes, Obesidad y Nutricion S.C Cuernavaca Morelos Mexico 62250
    97 Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey N.l. Mexico 64460
    98 Centro Para el Desarrollo de la Medicina y de Asistencia Med Culiacán Sinaloa Mexico 80230
    99 Investigacion en Salud y Metabolismo S.C Chihuahua Mexico 31217
    100 RM Pharma Specialists S.A. de C.V. Distrito Federal Mexico 3100
    101 Arke Estudios Clinicos S.A. de C.V. Veracruz Mexico 91910
    102 Manati Center for Clinical Research Inc Manati Puerto Rico 00674
    103 Ponce School of Medicine CAIMED Center Ponce Puerto Rico 00716
    104 Latin Clinical Trial Center San Juan Puerto Rico 00909
    105 GCM Medical Group, PSC- Hato Rey San Juan Puerto Rico 00917
    106 Consultorio Medico San Juan Puerto Rico 00921
    107 FSBI Scientific Research Institution of Therapy of Siberian Branch of RAMS Novosibirsk Novosibirsk Region Russian Federation 630089
    108 City Hospital #38 n. a. N.A. Semashko St. Petersburg Pushkin Russian Federation 196601
    109 Regional Public Health Institution "Cardiology Dispensary" Ivanovo Russian Federation 153012
    110 BHI of Republic Udmurtiya "City clinical hospital #9 of Ministry of healthcare of Republic Udmurtiya" Izhevsk Russian Federation 426063
    111 Clinical Trials Center of Medical Institute Kaliningrad Russian Federation 236035
    112 FSBI "National Medical Research Center for Preventive Medicine" of MOH of Russian Fed Moscow Russian Federation 101990
    113 FSBI Endocrinological Research Center of the MOH of the ROF Moscow Russian Federation 117036
    114 Pirogov Russian National Research Medical University Moscow Russian Federation 117997
    115 FSBI "National Medical Research Center of Cardiology" of MOH of Russian Federation Moscow Russian Federation 121552
    116 Chung Shan Medical University Hospital Taichung City Taiwan 40201
    117 China Medical University Hospital Taichung City Taiwan 40447
    118 Chi-Mei Medical Center Tainan City Taiwan 71004
    119 National Cheng Kung University Hospital Tainan Taiwan 70457
    120 National Taiwan University Hospital Taipei City Taiwan 10048

    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:
    NCT04184622
    Other Study ID Numbers:
    • 17244
    • I8F-MC-GPHK
    First Posted:
    Dec 3, 2019
    Last Update Posted:
    Apr 13, 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
    Prediabetes
    Additional relevant MeSH terms:
    Obesity
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Apr 13, 2022