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SURMOUNT-3: A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04657016
Collaborator
(none)
800
Enrollment
65
Locations
2
Arms
25.4
Anticipated Duration (Months)
12.3
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 obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Apr 13, 2023
Anticipated Study Completion Date :
May 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Placebo Comparator: 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 with ≥5% Body Weight Reduction [72 Weeks]

      Percentage of participants with ≥5% body weight reduction

    Secondary Outcome Measures

    1. Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program [72 Weeks]

      Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program

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

      Percentage of participants who achieve ≥10% body weight reduction

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

      Percentage of participants who achieve ≥15% body weight reduction

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

      Change from randomization in waist circumference

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

      Change from randomization in body weight

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

      Change from randomization in BMI

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

      Change from randomization in SBP

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

      Change from randomization in DBP

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

      Change from randomization in total cholesterol

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

      Change from randomization in HDL

    11. Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [Randomization, 72 Weeks]

      Change from randomization in LDL

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

      Change from randomization in VLDL

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

      Change from randomization in triglycerides

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

      Change from randomization in free fatty acids

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

      Change from randomization in fasting glucose

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

      Change from randomization in HbA1c

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

      Change from randomization in fasting insulin

    18. Change from Randomization in Short Form 36 Version 2 Health Survey (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 due to health problems; 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.

    19. 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.

    20. Change from Baseline in Absolute Body Weight [Baseline, 72 Weeks]

      Change from baseline in absolute body weight

    21. Percent Change From Baseline in Body Weight [Baseline, 72 Weeks]

      Percent change from baseline in body weight

    22. Change from Baseline in BMI [Baseline, 72 Weeks]

      Change from baseline in BMI

    23. Change from Baseline in Waist Circumference [Baseline, 72 Weeks]

      Change from baseline in waist circumference

    Eligibility Criteria

    Criteria

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

    • Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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 National Research Institute - Huntington Park Huntington Park California United States 90255
    2 National Research Institute - Wilshire Los Angeles California United States 90057
    3 Catalina Research Institute, LLC Montclair California United States 91763
    4 National Research Institute (NRI) - Santa Ana Santa Ana California United States 92704
    5 Encompass Clinical Research Spring Valley California United States 91978
    6 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
    7 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    8 Clinical Research of South Florida Coral Gables Florida United States 33134
    9 New Horizon Research Center Miami Florida United States 33165
    10 Precision Clinical Research Sunrise Florida United States 33351
    11 Clinical Research of West Florida Tampa Florida United States 33606
    12 Metabolic Research Institute, Inc. West Palm Beach Florida United States 33401
    13 Elite Clinical Trials Blackfoot Idaho United States 83221
    14 Solaris Clinical Research Meridian Idaho United States 83646
    15 Elite Clinical Trials Rexburg Idaho United States 83440
    16 Evanston Premier Healthcare Research LLC Evanston Illinois United States 60201
    17 American Health Network of IN, LLC Avon Indiana United States 46123
    18 American Health Network of IN, LLC Franklin Indiana United States 46131
    19 American Health Network of IN, LLC Muncie Indiana United States 47304
    20 Cotton O'Neil Mulvane Topeka Kansas United States 66606
    21 Tandem Clinical Research,LLC Marrero Louisiana United States 70072
    22 The National Diabetes & Obesity Research Institute Biloxi Mississippi United States 39532
    23 Clinvest Research LLC Springfield Missouri United States 65810
    24 Quality Clinical Research Omaha Nebraska United States 68114
    25 Palm Research Center Sunset Las Vegas Nevada United States 89148
    26 Rochester Clinical Research, Inc. Rochester New York United States 14609
    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 Cleveland Clinic Foundation Cleveland Ohio United States 44122
    31 Intend Research, LLC Norman Oklahoma United States 73069
    32 Summit Research Network Portland Oregon United States 97210
    33 Detweiler Family Medicine & Associates Lansdale Pennsylvania United States 19446
    34 Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    35 Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania United States 15243
    36 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    37 Holston Medical Group Bristol Tennessee United States 37620
    38 Vanderbilt Health One Hundred Oaks Nashville Tennessee United States 37204
    39 Dallas Diabetes Research Center Dallas Texas United States 75230
    40 Juno Research Houston Texas United States 77040
    41 Southern Endocrinology Associates Mesquite Texas United States 75149
    42 Texas Diabetes & Endocrinology, P.A. Round Rock Texas United States 78681
    43 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    44 Health Research of Hampton Roads, Inc. Newport News Virginia United States 23606
    45 MultiCare Institute for Research & Innovation Tacoma Washington United States 98405
    46 Centro Médico Viamonte Caba Buenos Aires Argentina C1120AAC
    47 Investigaciones Medicas Imoba Srl Caba Buenos Aires Argentina C1179AAB
    48 Instituto Centenario Caba Buenos Aires Argentina C1204AAD
    49 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
    50 Stat Research S.A. Ciudad Autónoma de Buenos Aire Buenos Aires Argentina C1023AAB
    51 Glenny Corp Buenos Aires Ciudad Autónoma De Buenos Aire Argentina 1430
    52 CEMEDIAB C.a.b.a. Ciudad Autónoma De Buenos Aire Argentina C1205AAO
    53 Instituto Médico Especializado (IME) Buenos Aires Argentina 1405
    54 Sanatorio Norte Santiago del Estero Argentina 4200
    55 CEDOES Vitória Espírito Santo Brazil 29055450
    56 Cline Research Center Curitiba Paraná Brazil 80030-480
    57 Quanta Diagnóstico e Terapia Curitiba Paraná Brazil 80040-110
    58 CPCLIN Sao Paulo São Paulo Brazil 01228-200
    59 BR Trials - Ensaios Clinicos e Consultoria Sao Paulo São Paulo Brazil 03325-050
    60 IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil 22241-180
    61 CPQuali Pesquisa Clínica São Paulo Brazil 01228-000
    62 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    63 Advanced Clinical Research, LLC Bayamon Puerto Rico 00961
    64 Manati Center for Clinical Research Manati Puerto Rico 00674
    65 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716

    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:
    NCT04657016
    Other Study ID Numbers:
    • 17246
    • I8F-MC-GPHM
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 15, 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
    Diet
    Exercise
    Metabolism and Nutrition Disorder
    Behavioral Modification
    Additional relevant MeSH terms:
    Obesity
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Mar 23, 2022