SURMOUNT-4: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04660643
Collaborator
(none)
750
70
2
25.6
10.7
0.4

Study Details

Study Description

Brief Summary

This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 visits).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 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 for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Apr 19, 2023
Anticipated Study Completion Date :
May 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (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 (Week 36) in Body Weight [Randomization, Week 88]

      Percent change from randomization in body weight

    Secondary Outcome Measures

    1. Change from Randomization in Body Weight [Randomization, Week 88]

      Change from randomization in body weight

    2. Change from Randomization in Waist Circumference [Randomization, Week 88]

      Change from randomization in waist circumference

    3. Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During the Open-Label Period [Week 88]

      Percentage of participants who maintain ≥80% of the body weight lost during the open-label period

    4. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Week 88]

      Percentage of participants who achieve ≥5% body weight reduction

    5. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 88]

      Percentage of participants who achieve ≥10% body weight reduction

    6. Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% during the Open-Label Period [Randomization, Week 88]

      Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label period

    7. Percent Change from Randomization in Body Weight [Randomization, Week 64]

      Percent change from randomization in body weight

    8. Change from Randomization in Body Mass Index (BMI) [Randomization, Week 88]

      Change from randomization in BMI

    9. Change from Randomization in Fasting Glucose [Randomization, Week 88]

      Change from randomization in fasting glucose

    10. Change from Randomization in Hemoglobin A1c (HbA1c) [Randomization, Week 88]

      Change from randomization in HbA1c

    11. Change from Randomization in Fasting Insulin [Randomization, Week 88]

      Change from randomization in fasting insulin

    12. Change from Randomization in Total Cholesterol [Randomization, Week 88]

      Change from randomization in total cholesterol

    13. Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [Randomization, Week 88]

      Change from randomization in LDL cholesterol

    14. Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [Randomization, Week 88]

      Change from randomization in HDL cholesterol

    15. Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [Randomization, Week 88]

      Change from randomization in VLDL cholesterol

    16. Change from Randomization in Triglycerides [Randomization, Week 88]

      Change from randomization in triglycerides

    17. Change from Randomization in Free Fatty Acids [Randomization, Week 88]

      Change from randomization in free fatty acids

    18. Change from Randomization in Systolic Blood Pressure (SBP) [Randomization, Week 88]

      Change from randomization in SBP

    19. Change from Randomization in Diastolic Blood Pressure (DBP) [Randomization, Week 88]

      Change from randomization in DBP

    20. Change from Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score [Randomization, Week 88]

      The 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.

    21. Change from Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [Randomization, Week 88]

      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. Change from Baseline in Body Weight [Baseline, Week 88]

      Change from baseline in body weight

    23. Percent Change from Baseline in Body Weight [Baseline, Week 88]

      Percent change from baseline in body weight

    24. Change from Baseline in BMI [Baseline, Week 88]

      Change from baseline in BMI

    25. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 88]

      Percentage of participants who achieve ≥15% body weight reduction

    26. Change from Baseline in Waist Circumference [Baseline, Week 88]

      Change from baseline in waist circumference

    27. Change from Baseline in Fasting Glucose [Baseline, Week 88]

      Change from baseline in fasting glucose

    28. Change from Baseline in HbA1c [Baseline, Week 88]

      Change from baseline in HbA1c

    29. Change from Baseline in Fasting Insulin [Baseline, Week 88]

      Change from baseline in fasting insulin

    30. Change from Baseline in Total Cholesterol [Baseline, Week 88]

      Change from baseline in total cholesterol

    31. Change from Baseline in HDL Cholesterol [Baseline, Week 88]

      Change from baseline in HDL cholesterol

    32. Change from Baseline in LDL Cholesterol [Baseline, Week 88]

      Change from baseline in LDL cholesterol

    33. Change from Baseline in VLDL Cholesterol [Baseline, Week 88]

      Change from baseline in VLDL cholesterol

    34. Change from Baseline in Triglycerides [Baseline, Week 88]

      Change from baseline in triglycerides

    35. Change from Baseline in Free Fatty Acids [Baseline, Week 88]

      Change from baseline in free fatty acids

    36. Change from Baseline in SBP [Baseline, Week 88]

      Change from baseline in SBP

    37. Change from Baseline in DBP [Baseline, Week 88]

      Change from baseline in DBP

    38. Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score [Baseline, Week 88]

      The SF-36v2 acute form, 1-week recall assesses participants' 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.

    39. Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score [Baseline, Week 88]

      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.

    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 Scripps Memorial Hospital La Jolla La Jolla California United States 92037
    3 National Research Institute - Wilshire Los Angeles California United States 90057
    4 National Research Institute Panorama City California United States 91402
    5 Artemis Institute for Clinical Research San Diego California United States 92103
    6 University Clinical Investigators, Inc. Tustin California United States 92780
    7 New West Physicians Clinical Research Golden Colorado United States 80401
    8 Optumcare Colorado Springs - Monument Monument Colorado United States 80132
    9 Care Partners Clinical Research Jacksonville Florida United States 32277
    10 South Florida Clinical Research Institute Margate Florida United States 33063
    11 Renstar Medical Research Ocala Florida United States 34470
    12 ForCare Clinical Research Tampa Florida United States 33613
    13 Endocrine Research Solutions, Inc. Roswell Georgia United States 30076
    14 SKY Clinical Research Network Group-Blake Union City Georgia United States 30291
    15 East-West Medical Research Institute Honolulu Hawaii United States 96814
    16 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    17 Healthcare Research Network - Chicago Flossmoor Illinois United States 60422
    18 Clinical Investigation Specialists Gurnee Illinois United States 60031
    19 Midwest Institute For Clinical Research Indianapolis Indiana United States 46260
    20 American Health Network of Indiana, LLC - New Albany New Albany Indiana United States 47150
    21 Cotton O'Neil Clinic Topeka Kansas United States 66606
    22 L-MARC Research Center Louisville Kentucky United States 40213
    23 Centennial Medical Group Elkridge Maryland United States 21075
    24 MedStar Health Research Institute (MedStar Physician Based Research Network) Hyattsville Maryland United States 20782
    25 ActivMed Practices and Research Methuen Massachusetts United States 01844
    26 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
    27 StudyMetrix Research Saint Peters Missouri United States 63303
    28 Glacier View Research Institute - Endocrinology Kalispell Montana United States 59901
    29 Weill Cornell Medical College New York New York United States 10065
    30 University of North Carolina Medical Center Chapel Hill North Carolina United States 27514
    31 PharmQuest Greensboro North Carolina United States 27408
    32 Wake Forest University Baptist Medical Center (WFUBMC) Winston-Salem North Carolina United States 27157
    33 Lillestol Research Fargo North Dakota United States 58104
    34 Aventiv Research Inc Columbus Ohio United States 43213
    35 Intend Research, LLC Norman Oklahoma United States 73069
    36 Summit Research Network Portland Oregon United States 97210
    37 Capital Area Research, LLC Camp Hill Pennsylvania United States 17011
    38 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    39 The University of Texas Health Science Center at Houston Bellaire Texas United States 77401
    40 Dallas Diabetes Research Center Dallas Texas United States 75230
    41 North Texas Endocrine Center Dallas Texas United States 75231
    42 Biopharma Informatic, LLC Houston Texas United States 77043
    43 North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas United States 76180
    44 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
    45 Northwest Houston Heart Center Tomball Texas United States 77375
    46 Health Research of Hampton Roads, Inc. Newport News Virginia United States 23606
    47 Capital Clinical Research Center Olympia Washington United States 98502
    48 Rainier Clinical Research Center Renton Washington United States 98057
    49 CEDIC Caba Buenos Aires Argentina C1060ABN
    50 Centro Médico Viamonte Caba Buenos Aires Argentina C1120AAC
    51 Stat Research S.A. Ciudad Autónoma de Buenos Aire Buenos Aires Argentina C1023AAB
    52 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
    53 Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1425AGC
    54 Instituto Médico Catamarca IMEC Rosario Santa Fe Argentina 2000
    55 Asociación de Beneficencia Hospital Sirio Libanés Buenos Aires Argentina C1419AHN
    56 CEDOES Vitória Espírito Santo Brazil 29055450
    57 Cline Research Center Curitiba Paraná Brazil 80030-480
    58 Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul Brazil 90430-001
    59 Centro de Pesquisa Sao Lucas Campinas São Paulo Brazil 13034-685
    60 BR Trials - Ensaios Clinicos e Consultoria Sao Paulo São Paulo Brazil 03325-050
    61 ISPEM - Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo Brazil 12243-280
    62 IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil 22241-180
    63 CPQuali Pesquisa Clínica São Paulo Brazil 01228-000
    64 Centro de Endocrinologia Alcantara Gonzalez Bayamon Puerto Rico 00959
    65 Private Practice Dr. Martha Gomez Cuellar San Juan Puerto Rico 00921
    66 Wellness clinical Research Vega Baja Vega Baja Puerto Rico 00694
    67 Chung Shan Medical University Hospital Taichung Taiwan 402
    68 China Medical University Hospital Taichung Taiwan 40447
    69 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704
    70 National Taiwan University Hospital Taipei Taiwan 10002

    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:
    NCT04660643
    Other Study ID Numbers:
    • 17247
    • I8F-MC-GPHN
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021