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

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 Diet, Exercise, Metabolism and Nutrition Disorder, Behavioral Modification

Eligibility Criteria

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

Inclusion Criteria:

  • Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
  • History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

  • Diabetes mellitus
  • Change in body weight greater than 5 kg within 3 months prior to starting study
  • Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
  • History of pancreatitis
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
  • Any lifetime history of a suicide attempt

Sites / Locations

  • National Research Institute - Huntington Park
  • National Research Institute - Wilshire
  • Catalina Research Institute, LLC
  • National Research Institute (NRI) - Santa Ana
  • Encompass Clinical Research
  • Diablo Clinical Research, Inc.
  • Chase Medical Research, LLC
  • Clinical Research of South Florida
  • New Horizon Research Center
  • Precision Clinical Research
  • Clinical Research of West Florida
  • Metabolic Research Institute, Inc.
  • Elite Clinical Trials
  • Solaris Clinical Research
  • Elite Clinical Trials
  • Evanston Premier Healthcare Research LLC
  • American Health Network of IN, LLC
  • American Health Network of IN, LLC
  • American Health Network of IN, LLC
  • Cotton O'Neil Mulvane
  • Tandem Clinical Research,LLC
  • The National Diabetes & Obesity Research Institute
  • Clinvest Research LLC
  • Quality Clinical Research
  • Palm Research Center Sunset
  • Rochester Clinical Research, Inc.
  • University of North Carolina Medical Center
  • PharmQuest
  • Wake Forest University Baptist Medical Center (WFUBMC)
  • Cleveland Clinic Foundation
  • Intend Research, LLC
  • Summit Research Network
  • Detweiler Family Medicine & Associates
  • Penn Medicine: University of Pennsylvania Health System
  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
  • Tribe Clinical Research, LLC
  • Holston Medical Group
  • Vanderbilt Health One Hundred Oaks
  • Dallas Diabetes Research Center
  • Juno Research
  • Southern Endocrinology Associates
  • Texas Diabetes & Endocrinology, P.A.
  • Consano Clinical Research, LLC
  • Health Research of Hampton Roads, Inc.
  • MultiCare Institute for Research & Innovation
  • Centro Médico Viamonte
  • Investigaciones Medicas Imoba Srl
  • Instituto Centenario
  • Centro de Investigaciones Metabólicas (CINME)
  • Stat Research S.A.
  • Glenny Corp
  • CEMEDIAB
  • Instituto Médico Especializado (IME)
  • Sanatorio Norte
  • CEDOES
  • Cline Research Center
  • Quanta Diagnóstico e Terapia
  • CPCLIN
  • BR Trials - Ensaios Clinicos e Consultoria
  • IBPClin - Instituto Brasil de Pesquisa Clínica
  • CPQuali Pesquisa Clínica
  • CEPIC - Centro Paulista de Investigação Clínica
  • Advanced Clinical Research, LLC
  • Manati Center for Clinical Research
  • Ponce Medical School Foundation Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tirzepatide

Placebo

Arm Description

Tirzepatide administered subcutaneously (SC)

Administered SC

Outcomes

Primary Outcome Measures

Percent Change from Randomization in Body Weight
Percent change from randomization in body weight
Percentage of Participants with ≥5% Body Weight Reduction
Percentage of participants with ≥5% body weight reduction

Secondary Outcome Measures

Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Change from Randomization in Waist Circumference
Change from randomization in waist circumference
Change from Randomization in Body Weight
Change from randomization in body weight
Change from Randomization in Body Mass Index (BMI)
Change from randomization in BMI
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 Total Cholesterol
Change from randomization in total cholesterol
Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Change from randomization in HDL
Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Change from randomization in LDL
Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol
Change from randomization in VLDL
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 Fasting Glucose
Change from randomization in fasting glucose
Change from Randomization in HbA1c
Change from randomization in HbA1c
Change from Randomization in Fasting Insulin
Change from randomization in fasting insulin
Change from Randomization in Short Form 36 Version 2 Health Survey (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 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 Absolute Body Weight
Change from baseline in absolute 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
Change from Baseline in Waist Circumference
Change from baseline in waist circumference

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
NCT04657016
Brief Title
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
Acronym
SURMOUNT-3
Official Title
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
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 20, 2023 (Actual)
Study Completion Date
May 12, 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. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
806 (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
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 with ≥5% Body Weight Reduction
Description
Percentage of participants with ≥5% body weight reduction
Time Frame
72 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
Description
Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program
Time Frame
72 Weeks
Title
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
Description
Percentage of participants who achieve ≥10% body weight reduction
Time Frame
72 Weeks
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Description
Percentage of participants who achieve ≥15% body weight reduction
Time Frame
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 Body Weight
Description
Change from randomization in 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 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 Total Cholesterol
Description
Change from randomization in total cholesterol
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Description
Change from randomization in HDL
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Description
Change from randomization in LDL
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol
Description
Change from randomization in VLDL
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 Fasting Glucose
Description
Change from randomization in fasting glucose
Time Frame
Randomization, 72 Weeks
Title
Change from Randomization in HbA1c
Description
Change from randomization in HbA1c
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 Version 2 Health Survey (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 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, 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
Change from Baseline in Absolute Body Weight
Description
Change from baseline in absolute body weight
Time Frame
Baseline, 72 Weeks
Title
Percent Change From Baseline in Body Weight
Description
Percent change from baseline in body weight
Time Frame
Baseline, 72 Weeks
Title
Change from Baseline in BMI
Description
Change from baseline in BMI
Time Frame
Baseline, 72 Weeks
Title
Change from Baseline in Waist Circumference
Description
Change from baseline in waist circumference
Time Frame
Baseline, 72 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease History of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: Diabetes mellitus Change in body weight greater than 5 kg within 3 months prior to starting study Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity History of pancreatitis Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years Any lifetime history of a suicide attempt
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
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Wilshire
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
National Research Institute (NRI) - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Precision Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
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
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Elite Clinical Trials
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
American Health Network of IN, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
American Health Network of IN, LLC
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
American Health Network of IN, LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Cotton O'Neil Mulvane
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Tandem Clinical Research,LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
The National Diabetes & Obesity Research Institute
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Palm Research Center Sunset
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
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
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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
Detweiler Family Medicine & Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Penn Medicine: University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Vanderbilt Health One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
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
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Investigaciones Medicas Imoba Srl
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Instituto Centenario
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1204AAD
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
Stat Research S.A.
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Glenny Corp
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1430
Country
Argentina
Facility Name
CEMEDIAB
City
C.a.b.a.
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1205AAO
Country
Argentina
Facility Name
Instituto Médico Especializado (IME)
City
Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Sanatorio Norte
City
Santiago del Estero
ZIP/Postal Code
4200
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
Quanta Diagnóstico e Terapia
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80040-110
Country
Brazil
Facility Name
CPCLIN
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01228-200
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
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
CEPIC - Centro Paulista de Investigação Clínica
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Advanced Clinical Research, LLC
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Manati Center for Clinical Research
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
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/1ZuH7WHjpse8JDpVFSSi1I
Description
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)

Learn more about this trial

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

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