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

Primary Purpose

Obesity, Overweight

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 Obesity focused on measuring Metabolism and Nutrition Disorder, Prediabetes

Eligibility Criteria

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

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

Sites / Locations

  • Cahaba Research
  • Scripps Memorial Hospital La Jolla
  • National Research Institute - Wilshire
  • National Research Institute
  • Artemis Institute for Clinical Research
  • University Clinical Investigators, Inc.
  • New West Physicians Clinical Research
  • Optumcare Colorado Springs - Monument
  • Care Partners Clinical Research
  • South Florida Clinical Research Institute
  • Renstar Medical Research
  • ForCare Clinical Research
  • Endocrine Research Solutions, Inc.
  • SKY Clinical Research Network Group-Blake
  • East-West Medical Research Institute
  • Rocky Mountain Clinical Research
  • Healthcare Research Network - Chicago
  • Clinical Investigation Specialists
  • Midwest Institute For Clinical Research
  • American Health Network of Indiana, LLC - New Albany
  • Cotton O'Neil Clinic
  • L-MARC Research Center
  • Centennial Medical Group
  • MedStar Health Research Institute (MedStar Physician Based Research Network)
  • ActivMed Practices and Research
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • StudyMetrix Research
  • Glacier View Research Institute - Endocrinology
  • Weill Cornell Medical College
  • University of North Carolina Medical Center
  • PharmQuest
  • Wake Forest University Baptist Medical Center (WFUBMC)
  • Lillestol Research
  • Aventiv Research Inc
  • Intend Research, LLC
  • Summit Research Network
  • Capital Area Research, LLC
  • Tribe Clinical Research, LLC
  • The University of Texas Health Science Center at Houston
  • Dallas Diabetes Research Center
  • North Texas Endocrine Center
  • Biopharma Informatic, LLC
  • North Hills Family Medicine/North Hills Medical Research
  • Clinical Trials of Texas, Inc.
  • Northwest Houston Heart Center
  • Health Research of Hampton Roads, Inc.
  • Capital Clinical Research Center
  • Rainier Clinical Research Center
  • CEDIC
  • Centro Médico Viamonte
  • Stat Research S.A.
  • Mautalen Salud e Investigación
  • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
  • Instituto Médico Catamarca IMEC
  • Asociación de Beneficencia Hospital Sirio Libanés
  • CEDOES
  • Cline Research Center
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul
  • Centro de Pesquisa Sao Lucas
  • BR Trials - Ensaios Clinicos e Consultoria
  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas
  • IBPClin - Instituto Brasil de Pesquisa Clínica
  • CPQuali Pesquisa Clínica
  • Centro de Endocrinologia Alcantara Gonzalez
  • Private Practice Dr. Martha Gomez Cuellar
  • Wellness clinical Research Vega Baja
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • National Cheng-Kung Uni. Hosp.
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tirzepatide

Placebo

Arm Description

Tirzepatide administered subcutaneously (SC)

Placebo administered SC

Outcomes

Primary Outcome Measures

Percent Change from Randomization (Week 36) in Body Weight
Percent change from randomization in body weight

Secondary Outcome Measures

Change from Randomization in Body Weight
Change from randomization in body weight
Change from Randomization in Waist Circumference
Change from randomization in waist circumference
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During the Open-Label Period
Percentage of participants who maintain ≥80% of the body weight lost during the open-label period
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% during the Open-Label Period
Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label period
Percent Change from Randomization in Body Weight
Percent change from randomization in body weight
Change from Randomization in Body Mass Index (BMI)
Change from randomization in BMI
Change from Randomization in Fasting Glucose
Change from randomization in fasting glucose
Change from Randomization in Hemoglobin A1c (HbA1c)
Change from randomization in HbA1c
Change from Randomization in Fasting Insulin
Change from randomization in fasting insulin
Change from Randomization in Total Cholesterol
Change from randomization in total cholesterol
Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Change from randomization in LDL cholesterol
Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Change from randomization in HDL cholesterol
Change from Randomization in Very Low Density Lipoprotein (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 Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score
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.
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.
Change from Baseline in Body Weight
Change from baseline in body weight
Percent Change from Baseline in Body Weight
Percent change from baseline in body weight
Change from Baseline in BMI
Change from baseline in BMI
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Change from Baseline in Waist Circumference
Change from baseline in waist circumference
Change from Baseline in Fasting Glucose
Change from baseline in fasting glucose
Change from Baseline in HbA1c
Change from baseline in HbA1c
Change from Baseline in Fasting Insulin
Change from baseline in fasting insulin
Change from Baseline in Total Cholesterol
Change from baseline in total cholesterol
Change from Baseline in HDL Cholesterol
Change from baseline in HDL cholesterol
Change from Baseline in LDL Cholesterol
Change from baseline in LDL cholesterol
Change from Baseline in VLDL Cholesterol
Change from baseline in VLDL cholesterol
Change from Baseline in Triglycerides
Change from baseline in triglycerides
Change from Baseline in Free Fatty Acids
Change from baseline in free fatty acids
Change from Baseline in SBP
Change from baseline in SBP
Change from Baseline in DBP
Change from baseline in DBP
Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score
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.
Change from Baseline in 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.

Full Information

First Posted
December 1, 2020
Last Updated
May 23, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04660643
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Acronym
SURMOUNT-4
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
May 18, 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 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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (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 (Week 36) in Body Weight
Description
Percent change from randomization in body weight
Time Frame
Randomization, Week 88
Secondary Outcome Measure Information:
Title
Change from Randomization in Body Weight
Description
Change from randomization in body weight
Time Frame
Randomization, Week 88
Title
Change from Randomization in Waist Circumference
Description
Change from randomization in waist circumference
Time Frame
Randomization, Week 88
Title
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During the Open-Label Period
Description
Percentage of participants who maintain ≥80% of the body weight lost during the open-label period
Time Frame
Week 88
Title
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Description
Percentage of participants who achieve ≥5% body weight reduction
Time Frame
Week 88
Title
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Description
Percentage of participants who achieve ≥10% body weight reduction
Time Frame
Week 88
Title
Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% during the Open-Label Period
Description
Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label period
Time Frame
Randomization, Week 88
Title
Percent Change from Randomization in Body Weight
Description
Percent change from randomization in body weight
Time Frame
Randomization, Week 64
Title
Change from Randomization in Body Mass Index (BMI)
Description
Change from randomization in BMI
Time Frame
Randomization, Week 88
Title
Change from Randomization in Fasting Glucose
Description
Change from randomization in fasting glucose
Time Frame
Randomization, Week 88
Title
Change from Randomization in Hemoglobin A1c (HbA1c)
Description
Change from randomization in HbA1c
Time Frame
Randomization, Week 88
Title
Change from Randomization in Fasting Insulin
Description
Change from randomization in fasting insulin
Time Frame
Randomization, Week 88
Title
Change from Randomization in Total Cholesterol
Description
Change from randomization in total cholesterol
Time Frame
Randomization, Week 88
Title
Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Description
Change from randomization in LDL cholesterol
Time Frame
Randomization, Week 88
Title
Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Description
Change from randomization in HDL cholesterol
Time Frame
Randomization, Week 88
Title
Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol
Description
Change from randomization in VLDL cholesterol
Time Frame
Randomization, Week 88
Title
Change from Randomization in Triglycerides
Description
Change from randomization in triglycerides
Time Frame
Randomization, Week 88
Title
Change from Randomization in Free Fatty Acids
Description
Change from randomization in free fatty acids
Time Frame
Randomization, Week 88
Title
Change from Randomization in Systolic Blood Pressure (SBP)
Description
Change from randomization in SBP
Time Frame
Randomization, Week 88
Title
Change from Randomization in Diastolic Blood Pressure (DBP)
Description
Change from randomization in DBP
Time Frame
Randomization, Week 88
Title
Change from Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score
Description
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.
Time Frame
Randomization, Week 88
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, Week 88
Title
Change from Baseline in Body Weight
Description
Change from baseline in body weight
Time Frame
Baseline, Week 88
Title
Percent Change from Baseline in Body Weight
Description
Percent change from baseline in body weight
Time Frame
Baseline, Week 88
Title
Change from Baseline in BMI
Description
Change from baseline in BMI
Time Frame
Baseline, Week 88
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Description
Percentage of participants who achieve ≥15% body weight reduction
Time Frame
Week 88
Title
Change from Baseline in Waist Circumference
Description
Change from baseline in waist circumference
Time Frame
Baseline, Week 88
Title
Change from Baseline in Fasting Glucose
Description
Change from baseline in fasting glucose
Time Frame
Baseline, Week 88
Title
Change from Baseline in HbA1c
Description
Change from baseline in HbA1c
Time Frame
Baseline, Week 88
Title
Change from Baseline in Fasting Insulin
Description
Change from baseline in fasting insulin
Time Frame
Baseline, Week 88
Title
Change from Baseline in Total Cholesterol
Description
Change from baseline in total cholesterol
Time Frame
Baseline, Week 88
Title
Change from Baseline in HDL Cholesterol
Description
Change from baseline in HDL cholesterol
Time Frame
Baseline, Week 88
Title
Change from Baseline in LDL Cholesterol
Description
Change from baseline in LDL cholesterol
Time Frame
Baseline, Week 88
Title
Change from Baseline in VLDL Cholesterol
Description
Change from baseline in VLDL cholesterol
Time Frame
Baseline, Week 88
Title
Change from Baseline in Triglycerides
Description
Change from baseline in triglycerides
Time Frame
Baseline, Week 88
Title
Change from Baseline in Free Fatty Acids
Description
Change from baseline in free fatty acids
Time Frame
Baseline, Week 88
Title
Change from Baseline in SBP
Description
Change from baseline in SBP
Time Frame
Baseline, Week 88
Title
Change from Baseline in DBP
Description
Change from baseline in DBP
Time Frame
Baseline, Week 88
Title
Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score
Description
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.
Time Frame
Baseline, Week 88
Title
Change from Baseline in 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
Baseline, Week 88

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Cahaba Research
City
Pelham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Facility Name
Scripps Memorial Hospital La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
New West Physicians Clinical Research
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Optumcare Colorado Springs - Monument
City
Monument
State/Province
Colorado
ZIP/Postal Code
80132
Country
United States
Facility Name
Care Partners Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
South Florida Clinical Research Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
SKY Clinical Research Network Group-Blake
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Healthcare Research Network - Chicago
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Clinical Investigation Specialists
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Midwest Institute For Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
American Health Network of Indiana, LLC - New Albany
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
MedStar Health Research Institute (MedStar Physician Based Research Network)
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
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
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Glacier View Research Institute - Endocrinology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
North Hills Family Medicine/North Hills Medical Research
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northwest Houston Heart Center
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
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
Capital Clinical Research Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
CEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1060ABN
Country
Argentina
Facility Name
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Stat Research S.A.
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Mautalen Salud e Investigación
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Instituto Médico Catamarca IMEC
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
CEDOES
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055450
Country
Brazil
Facility Name
Cline Research Center
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030-480
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13034-685
Country
Brazil
Facility Name
BR Trials - Ensaios Clinicos e Consultoria
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03325-050
Country
Brazil
Facility Name
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12243-280
Country
Brazil
Facility Name
IBPClin - Instituto Brasil de Pesquisa Clínica
City
Rio de Janeiro
ZIP/Postal Code
22241-180
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Centro de Endocrinologia Alcantara Gonzalez
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
Private Practice Dr. Martha Gomez Cuellar
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Wellness clinical Research Vega Baja
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng-Kung Uni. Hosp.
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
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
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://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/aK2GGZSCqbdJMNUlhfAVV
Description
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4)

Learn more about this trial

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

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