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

Primary Purpose

Type 2 Diabetes, Overweight, Obesity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama - Department of Nutrition Sciences
  • KLR Business Group, Inc. dba Arkansas Clinical Research
  • Velocity Clinical Research, Huntington Park
  • Velocity Clinical Research, Westlake
  • Catalina Research Institute, LLC
  • Encompass Clinical Research
  • University Clinical Investigators, Inc.
  • ALL Medical Research, LLC
  • Northeast Research Institute (NERI)
  • New Horizon Research Center
  • West Orange Endocrinology
  • Metabolic Research Institute, Inc.
  • Emory University School of Medicine- Grady Campus
  • East Coast Institute for Research, LLC
  • Pacific Diabetes & Endocrine Center
  • Elite Clinical Trials
  • Rocky Mountain Clinical Research
  • American Health Network of Indiana, LLC - Greenfield
  • Iowa Diabetes and Endocrinology Research Center
  • Cotton O'Neil Clinical Research Center
  • Maryland Cardiovascular Specialists
  • MD Medical Research
  • NECCR PrimaCare Research
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Logan Health Research
  • Premier Research
  • University of North Carolina Medical Center
  • PharmQuest
  • Wake Forest University Baptist Medical Center (WFUBMC)
  • Velocity Clinical Research, Cleveland
  • Aventiv Research
  • The Corvallis Clinic, P.C.
  • Preferred Primary Care Physicians
  • Center for Neurosciences
  • Tribe Clinical Research, LLC
  • Texas Diabetes & Endocrinology, P.A.
  • Dallas Diabetes Research Center
  • Diabetes and Thyroid Center of Fort Worth
  • Juno Research
  • Endocrine Ips, Pllc
  • Health Research of Hampton Roads, Inc.
  • Rainier Clinical Research Center
  • Clinical Investigation Specialists
  • Consultorio de Investigación Clínica EMO SRL
  • Centro de Investigaciones Metabólicas (CINME)
  • Instituto de Investigaciones Clínicas Mar del Plata
  • Go Centro Medico San Nicolás
  • Centro Médico Viamonte
  • CIPREC
  • Centro de Investigaciones Médicas Tucuman
  • Sanatorio Norte
  • Private Practice - Dr.Miguel N. Hissa
  • Loema Instituto de Pesquisa Clinica
  • Instituto de Pesquisa clinica de Campinas
  • CECIP - Centro de Estudos do Interior Paulista
  • CPCLIN
  • CEPIC - Centro Paulista de Investigação Clínica
  • Life Care Hospital and Research Centre
  • ILS Hospitals
  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Medical Corporation Heishinkai OCROM Clinic
  • Medical Corporation Sato Medical clinic
  • AMC Nishiumeda Clinic
  • Centro de Endocrinologia y Nutricion
  • Latin Clinical Trial Center
  • GCM Medical Group, PSC - Hato Rey Site
  • Endocrinology Research Center of Rosmedtechnologies
  • Russian Medical Academy of Postgraduate Education
  • Saint-Petersburg City Hospital of Saint Elizabeth
  • Smolensk State Medical University
  • Changhua Christian Hospital
  • Chi Mei Medical Center
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng-Kung Uni. Hosp.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

10 mg Tirzepatide administered subcutaneously (SC)

15 mg Tirzepatide administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

Percent Change from Randomization in Body Weight
Percent Change from randomization in body weight
Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization
Percentage of participants who achieve ≥5% body weight reduction from randomization

Secondary Outcome Measures

Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization
Percentage of participants who achieve ≥10% body weight reduction from randomization
Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline
Percentage of participants who achieve ≥15% body weight reduction from randomization
Change from Randomization in Absolute Body Weight
Change from randomization in absolute body weight
Change from Randomization in Body Mass Index (BMI)
Change from randomization in BMI
Change from Randomization in HbA1c
Change from randomization in HbA1c
Percentage of Participants who Achieve HbA1c <7%
Percentage of Participants who Achieve HbA1c <7%
Percentage of Participants Who Achieve HbA1c ≤6.5%
Percentage of participants who achieve HbA1c ≤6.5%
Percentage of Participants Who Achieve HbA1c <5.7%
Percentage of participants who achieve HbA1c <5.7%
Change from Randomization in Fasting Glucose
Change from randomization in fasting glucose
Change from Randomization in Waist Circumference
Change from randomization in waist circumference
Change from Randomization in Total Cholesterol
Change from randomization in total cholesterol
Change from Randomization in Low Density Lipid (LDL)-Cholesterol
Change from randomization in LDL-cholesterol
Change from Randomization in High Density Lipid (HDL) Cholesterol
Change from randomization in HDL cholesterol
Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol
Change from randomization in VLDL cholesterol
Change from Randomization in Triglycerides
Change from randomization in triglycerides
Change from Randomization in Free Fatty Acids
Change from randomization in free fatty acids
Change from Randomization in Systolic Blood Pressure (SBP)
Change from randomization in SBP
Change from Randomization in Diastolic Blood Pressure (DBP)
Change from randomization in DBP
Change from Randomization in Fasting Insulin
Change from randomization in fasting insulin
Change from Randomization in Short Form 36 Health Survey version 2 (SF-36v2) acute form Physical Functioning domain score
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.
Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score
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.
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
PK: Steady State AUC of Tirzepatide

Full Information

First Posted
December 1, 2020
Last Updated
April 12, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04657003
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Acronym
SURMOUNT-2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Overweight, Obesity
Keywords
Metabolism and Nutrition Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
938 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg Tirzepatide administered subcutaneously (SC)
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg Tirzepatide administered SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change from Randomization in Body Weight
Description
Percent Change from randomization in body weight
Time Frame
Randomization, 72 Weeks
Title
Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization
Description
Percentage of participants who achieve ≥5% body weight reduction from randomization
Time Frame
72 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization
Description
Percentage of participants who achieve ≥10% body weight reduction from randomization
Time Frame
72 Weeks
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline
Description
Percentage of participants who achieve ≥15% body weight reduction from randomization
Time Frame
72 Weeks
Title
Change from Randomization in Absolute Body Weight
Description
Change from randomization in absolute body weight
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Body Mass Index (BMI)
Description
Change from randomization in BMI
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in HbA1c
Description
Change from randomization in HbA1c
Time Frame
Randomization, 72 Weeks
Title
Percentage of Participants who Achieve HbA1c <7%
Description
Percentage of Participants who Achieve HbA1c <7%
Time Frame
72 Weeks
Title
Percentage of Participants Who Achieve HbA1c ≤6.5%
Description
Percentage of participants who achieve HbA1c ≤6.5%
Time Frame
72 Weeks
Title
Percentage of Participants Who Achieve HbA1c <5.7%
Description
Percentage of participants who achieve HbA1c <5.7%
Time Frame
72 Weeks
Title
Change from Randomization in Fasting Glucose
Description
Change from randomization in fasting glucose
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Waist Circumference
Description
Change from randomization in waist circumference
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Total Cholesterol
Description
Change from randomization in total cholesterol
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Low Density Lipid (LDL)-Cholesterol
Description
Change from randomization in LDL-cholesterol
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in High Density Lipid (HDL) Cholesterol
Description
Change from randomization in HDL cholesterol
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol
Description
Change from randomization in VLDL cholesterol
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Triglycerides
Description
Change from randomization in triglycerides
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Free Fatty Acids
Description
Change from randomization in free fatty acids
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Systolic Blood Pressure (SBP)
Description
Change from randomization in SBP
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Diastolic Blood Pressure (DBP)
Description
Change from randomization in DBP
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Fasting Insulin
Description
Change from randomization in fasting insulin
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Short Form 36 Health Survey version 2 (SF-36v2) acute form Physical Functioning domain score
Description
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.
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score
Description
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.
Time Frame
Randomization, 72 Weeks
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
Description
PK: Steady State AUC of Tirzepatide
Time Frame
Baseline through Week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama - Department of Nutrition Sciences
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
KLR Business Group, Inc. dba Arkansas Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Velocity Clinical Research, Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Velocity Clinical Research, Westlake
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Northeast Research Institute (NERI)
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
West Orange Endocrinology
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Emory University School of Medicine- Grady Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Pacific Diabetes & Endocrine Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
American Health Network of Indiana, LLC - Greenfield
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Maryland Cardiovascular Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
NECCR PrimaCare Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Logan Health Research
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Velocity Clinical Research, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
The Corvallis Clinic, P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Center for Neurosciences
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Thyroid Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Clinical Investigation Specialists
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1405BUB
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1056
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Go Centro Medico San Nicolás
City
San Nicolas
State/Province
Buenos Aires
ZIP/Postal Code
2900
Country
Argentina
Facility Name
Centro Médico Viamonte
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
CIPREC
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1061AAS
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Sanatorio Norte
City
Santiago del Estero
ZIP/Postal Code
4200
Country
Argentina
Facility Name
Private Practice - Dr.Miguel N. Hissa
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-350
Country
Brazil
Facility Name
Loema Instituto de Pesquisa Clinica
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13010-001
Country
Brazil
Facility Name
Instituto de Pesquisa clinica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
CECIP - Centro de Estudos do Interior Paulista
City
Jaú
State/Province
São Paulo
ZIP/Postal Code
17201130
Country
Brazil
Facility Name
CPCLIN
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Life Care Hospital and Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
ILS Hospitals
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700064
Country
India
Facility Name
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Medical Corporation Sato Medical clinic
City
Ootaku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
AMC Nishiumeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Centro de Endocrinologia y Nutricion
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Facility Name
Endocrinology Research Center of Rosmedtechnologies
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Education
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Saint-Petersburg City Hospital of Saint Elizabeth
City
Saint Petersburg
State/Province
Sankt-Pete
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Changhua Christian Hospital
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Cheng-Kung Uni. Hosp.
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://www.vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6Lso9L1WmsU8ly9DkEFiaU
Description
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight (SURMOUNT-2)

Learn more about this trial

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

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