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
Recruiting
CT.gov ID
NCT04657003
Collaborator
(none)
900
Enrollment
80
Locations
3
Arms
24.6
Anticipated Duration (Months)
11.3
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 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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1University of Alabama - Department of Nutrition SciencesBirminghamAlabamaUnited States35294
    2KLR Business Group, Inc. dba Arkansas Clinical ResearchLittle RockArkansasUnited States72205
    3National Research Institute - Huntington ParkHuntington ParkCaliforniaUnited States90255
    4National Research Institute - WilshireLos AngelesCaliforniaUnited States90057
    5Catalina Research Institute, LLCMontclairCaliforniaUnited States91763
    6Encompass Clinical ResearchSpring ValleyCaliforniaUnited States91978
    7University Clinical Investigators, Inc.TustinCaliforniaUnited States92780
    8Yale University School of MedicineNew HavenConnecticutUnited States06519
    9ALL Medical Research, LLCCooper CityFloridaUnited States33024
    10Northeast Research Institute (NERI)Fleming IslandFloridaUnited States32003
    11New Horizon Research CenterMiamiFloridaUnited States33165
    12West Orange EndocrinologyOcoeeFloridaUnited States34761
    13Metabolic Research Institute, Inc.West Palm BeachFloridaUnited States33401
    14Emory University School of Medicine- Grady CampusAtlantaGeorgiaUnited States30303
    15Atlanta Diabetes AssociatesAtlantaGeorgiaUnited States30318
    16East Coast Institute for Research at The Jones CenterMaconGeorgiaUnited States31210
    17Pacific Diabetes & Endocrine CenterHonoluluHawaiiUnited States96813
    18Elite Clinical TrialsBlackfootIdahoUnited States83221
    19Rocky Mountain Clinical ResearchIdaho FallsIdahoUnited States83404
    20Elite Clinical TrialsRexburgIdahoUnited States83440
    21American Health Network of IN, LLCGreenfieldIndianaUnited States46140
    22Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowaUnited States50265
    23Cotton O'Neil ClinicTopekaKansasUnited States66606
    24Maryland Cardiovascular SpecialistsBaltimoreMarylandUnited States21229
    25MD Medical ResearchOxon HillMarylandUnited States20745
    26NECCR PrimaCare ResearchFall RiverMassachusettsUnited States02721
    27Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichiganUnited States48098
    28Logan Health ResearchKalispellMontanaUnited States59901
    29Premier ResearchTrentonNew JerseyUnited States08611
    30University of North Carolina Medical CenterChapel HillNorth CarolinaUnited States27514
    31PharmQuestGreensboroNorth CarolinaUnited States27408
    32Wake Forest University Baptist Medical Center (WFUBMC)Winston-SalemNorth CarolinaUnited States27157
    33Velocity Clinical Research, ClevelandClevelandOhioUnited States44122
    34Aventiv ResearchDublinOhioUnited States43016
    35The Corvallis Clinic, P.C.CorvallisOregonUnited States97330
    36Preferred Primary Care PhysiciansUniontownPennsylvaniaUnited States15401
    37Velocity Clinical Research, ProvidenceWarwickRhode IslandUnited States02886
    38Tribe Clinical Research, LLCGreenvilleSouth CarolinaUnited States29607
    39Texas Diabetes & Endocrinology, P.A.AustinTexasUnited States78749
    40Dallas Diabetes Research CenterDallasTexasUnited States75230
    41Diabetes and Thyroid Center of Fort WorthFort WorthTexasUnited States76132
    42Juno Research - GessnerHoustonTexasUnited States77074
    43Endocrine Ips, PllcHoustonTexasUnited States77079
    44Health Research of Hampton Roads, Inc.Newport NewsVirginiaUnited States23606
    45Rainier Clinical Research CenterRentonWashingtonUnited States98057
    46Clinical Investigation SpecialistsKenoshaWisconsinUnited States53144
    47CIPREC-Centro de Investigacion y Prevencion Cardiovascular-CabaBuenos AiresArgentinaC1119ACN
    48Consultorio de Investigación Clínica EMO SRLCiudad Autonoma de Buenos AireBuenos AiresArgentinaC1405BUB
    49Centro de Investigaciones Metabólicas (CINME)Ciudad Autónoma de Buenos AireBuenos AiresArgentina1056
    50Instituto de Investigaciones Clínicas Mar del PlataMar del PlataBuenos AiresArgentina7600
    51Go Centro Medico San NicolásSan NicolasBuenos AiresArgentina2900
    52Centro Médico ViamonteBuenos AiresCiudad Autónoma De Buenos AireArgentinaC1120AAC
    53Centro de Investigaciones Médicas TucumanSAN M. DE TucumanTucumánArgentinaT4000AXL
    54Sanatorio NorteSantiago del EsteroArgentina4200
    55Private Practice - Dr.Miguel N. HissaFortalezaCearáBrazil60160-140
    56Loema Instituto de Pesquisa ClinicaCampinasSão PauloBrazil13010-001
    57Instituto de Pesquisa clinica de CampinasCampinasSão PauloBrazil13060-080
    58CECIP - Centro de Estudos do Interior PaulistaJaúSão PauloBrazil17201130
    59CPCLINSao PauloSão PauloBrazil01228-200
    60CEPIC - Centro Paulista de Investigação ClínicaSão PauloBrazil04266-010
    61All India Institute of Medical SciencesNew DelhiDelhiIndia110029
    62Life Care Hospital and Research CentreBangaloreKarnatakaIndia560092
    63ILS HospitalsKolkataWest BengalIndia700064
    64Medical Corporation Yuga Tsuruma Kaneshiro Diabetes ClinicYamato-shiKanagawaJapan242-0004
    65Medical Corporation Heishinkai OCROM ClinicSuita-shiOsakaJapan565-0853
    66Sato Medical ClinicOotakuTokyoJapan143-0015
    67AMC Nishiumeda ClinicOsakaJapan530-0001
    68Centro de Endocrinologia y NutricionCaguasPuerto Rico725
    69Latin Clinical Trial CenterSan JuanPuerto Rico909
    70GCM Medical Group, PSC - Hato Rey SiteSan JuanPuerto Rico917
    71Endocrinology Research Center of RosmedtechnologiesMoscowMoskvaRussian Federation117036
    72Endocrinology Research Center of RosmedtechnologiesMoscowMoskvaRussian Federation117036
    73Russian Medical Academy of Postgraduate EducationMoscowMoskvaRussian Federation125284
    74Saint-Petersburg City Hospital of Saint ElizabethСанкт-ПетербургSankt-PeterburgRussian Federation195257
    75Smolensk State Medical UniversitySmolenskRussian Federation214019
    76Changhua Christian HospitalChanghua CountyChanghuaTaiwan50006
    77Chi Mei Medical CenterTainan CityTainanTaiwan71004
    78Chung Shan Medical University HospitalTaichungTaiwan402
    79Taichung Veterans General HospitalTaichungTaiwan407
    80National Cheng-Kung Uni. Hosp.TainanTaiwan704

    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:
    Nov 22, 2021
    Last Verified:
    Nov 15, 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 Nov 22, 2021