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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

Primary Purpose

Overweight, Obesity

Status
Active
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 Overweight 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
  • Perseverance Research Center
  • John Muir Physician Network Clinical Research Center
  • Valley Endocrine, Fresno
  • National Research Institute - Huntington Park
  • Catalina Research Institute, LLC
  • Encompass Clinical Research
  • University Clinical Investigators, Inc.
  • CMR of Greater New Haven
  • Yale University School of Medicine
  • Suncoast Research Group
  • New Horizon Research Center
  • Renstar Medical Research
  • Oviedo Medical Research
  • ForCare Clinical Research
  • United Osteoporosis Center
  • Herman Clinical Research, LLC
  • East-West Medical Research Institute
  • Midwest Institute for Clinical Research
  • Iowa Diabetes and Endocrinology Research Center
  • Cotton O'Neil Clinic
  • L-MARC Research Center
  • NECCR PrimaCare Research
  • ActivMed Practices and Research
  • Troy Internal Medicine, PC
  • Sky Clin Resch - Quinn HC
  • StudyMetrix Research
  • Clinvest Research LLC
  • Palm Research Center Tenaya
  • Premier Research
  • NYU Langone
  • Weill Cornell Medicine, Comprehensive Weight Control Center
  • Rochester Clinical Research, Inc.
  • University of North Carolina Diabetes Center
  • PharmQuest
  • Lillestol Research LLC
  • Rapid Medical Research
  • Aventiv Research Inc
  • Intend Research, LLC
  • Summit Research Network Inc
  • Detweiler Family Medicine & Associates
  • Preferred Primary Care Physicians - Jacob Murphy Lane
  • Omega Medical Research
  • Medical University of South Carolina
  • Mountain View Clinical Research, Inc.
  • Coastal Carolina Research Center
  • WR-Clinsearch, LLC
  • Texas Diabetes & Endocrinology, P.A.
  • Dallas Diabetes Research Center
  • North Texas Endocrine Center
  • Research Institute of Dallas
  • Southern Endocrinology Associates
  • Texas Diabetes & Endocrinology, P.A.
  • Consano Clinical Research, LLC
  • Stat Research
  • Centro de Investigaciones Metabólicas (CINME)
  • Centro Médico Viamonte
  • Mautalen Salud e Investigación - Servicio de Endocrinología
  • Consultorio de Investigación Clínica EMO SRL
  • CEDIC
  • Instituto de Investigaciones Clínicas Mar del Plata
  • DIM Clinica Privada
  • GO Centro Médico San Nicolás
  • Centro Medico Privado de Reumatologia
  • Sanatorio Norte
  • CEDOES
  • Loema - Instituto de Pesquisa Clinica
  • CPQuali Pesquisa Clínica
  • CPCLIN
  • CEPIC - Centro Paulista de Investigação Clínica
  • Hospital da Clinicas da Faculdade de Medicina da USP
  • IPECC - Instituto de Pesquisa Clinica de Campinas
  • Instituto Brasil de Pesquisa Clínica - IBPCLIN
  • The Second Affiliated Hospital of Nanjing Medical University
  • The Fourth Affiliated Hospital of Harbin Medical University
  • Jinan Central Hospital
  • The First Affiliated Hospital of Xi'an Medical University
  • West China Hospital Sichuan University
  • Ningbo First Hospital
  • Beijing Tsinghua Changgung Hospital
  • Care Hospital
  • Gujarat Endocrine Center
  • Grant Medical College & Sir J.J. Group of Hospitals
  • Deenanath Mangeshkar Hospital & Research Centre
  • ILS Hospital
  • Fortis Hospital
  • OCROM Clinic
  • Tokyo-Eki Center-building Clinic
  • Medical Corporation Chiseikai Tokyo Center Clinic
  • Fukuwa Clinic
  • AMC nishi-umeda clinic
  • Ctro Inv en Artritis y Osteoporosis SC
  • Centro Especializado en Diabetes Obesidad y Enfermedades
  • Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.
  • Virgen Cardiovascular Research S.C
  • Inst. de Diabetes, Obesidad y Nutricion S.C
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Centro Para el Desarrollo de la Medicina y de Asistencia Med
  • Investigacion en Salud y Metabolismo S.C
  • RM Pharma Specialists S.A. de C.V.
  • Arke Estudios Clinicos S.A. de C.V.
  • Manati Center for Clinical Research Inc
  • Ponce School of Medicine CAIMED Center
  • Latin Clinical Trial Center
  • GCM Medical Group, PSC- Hato Rey
  • Consultorio Medico
  • FSBI Scientific Research Institution of Therapy of Siberian Branch of RAMS
  • City Hospital #38 n. a. N.A. Semashko
  • Regional Public Health Institution "Cardiology Dispensary"
  • BHI of Republic Udmurtiya "City clinical hospital #9 of Ministry of healthcare of Republic Udmurtiya"
  • Clinical Trials Center of Medical Institute
  • FSBI "National Medical Research Center for Preventive Medicine" of MOH of Russian Fed
  • FSBI Endocrinological Research Center of the MOH of the ROF
  • Pirogov Russian National Research Medical University
  • FSBI "National Medical Research Center of Cardiology" of MOH of Russian Federation
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • Chi-Mei Medical Center
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

10 mg tirzepatide administered SC once a week.

15 mg tirzepatide administered SC once a week.

Placebo administered SC once a week.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Body Weight
Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction.

Secondary Outcome Measures

Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Percent Change From Baseline in Body Weight
Percent Change from Baseline in Body Weight.
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.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of Participants who Achieve ≥5% Body Weight Reduction.
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Percentage of participants who achieve ≥20% body weight reduction.
Change From Baseline in Waist Circumference
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Change From Baseline in Body Mass Index (BMI)
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Change From Baseline in Fasting Glucose
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Time to Onset of Type 2 Diabetes
Time to Onset of Type 2 Diabetes
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg)
The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.

Full Information

First Posted
December 2, 2019
Last Updated
July 11, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04184622
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Acronym
SURMOUNT-1
Official Title
Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
July 8, 2024 (Anticipated)

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
Yes

5. Study Description

Brief Summary
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
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
2539 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once a week.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once a week.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight
Description
Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Description
Percentage of participants who achieve ≥5% body weight reduction.
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 20
Title
Percent Change From Baseline in Body Weight
Description
Percent Change from Baseline in Body Weight.
Time Frame
Baseline, Week 176
Title
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Description
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Time Frame
Week 72
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Description
Percentage of participants who achieve ≥15% body weight reduction.
Time Frame
Week 72
Title
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Description
Percentage of Participants who Achieve ≥5% Body Weight Reduction.
Time Frame
Week 176
Title
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Description
Percentage of participants who achieve ≥20% body weight reduction.
Time Frame
Week 72
Title
Change From Baseline in Waist Circumference
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Body Mass Index (BMI)
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Fasting Glucose
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Time to Onset of Type 2 Diabetes
Description
Time to Onset of Type 2 Diabetes
Time Frame
Baseline through Week 176
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Description
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Description
The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Description
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Time Frame
Baseline, Week 72
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Description
PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.
Time Frame
Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

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
Perseverance Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Valley Endocrine, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute - Huntington Park
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
CMR of Greater New Haven
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165 3338
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Oviedo Medical Research
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
United Osteoporosis Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Herman Clinical Research, LLC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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 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
NECCR PrimaCare Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Troy Internal Medicine, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Sky Clin Resch - Quinn HC
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Palm Research Center Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medicine, Comprehensive Weight Control Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
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 Diabetes Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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 Inc
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
Preferred Primary Care Physicians - Jacob Murphy Lane
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
WR-Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4309
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
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
Stat Research
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1013AAB
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Mautalen Salud e Investigación - Servicio de Endocrinología
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1405BUB
Country
Argentina
Facility Name
CEDIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DES
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
DIM Clinica Privada
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Facility Name
GO Centro Médico San Nicolás
City
San Nicolás
State/Province
Buenos Aires
ZIP/Postal Code
B2900DPA
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel De Tucumán
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
CEDOES
City
Vitoria
State/Province
ES
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Loema - Instituto de Pesquisa Clinica
City
Campinas
State/Province
SP
ZIP/Postal Code
13010-001
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
CPCLIN
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica
City
São Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Hospital da Clinicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
IPECC - Instituto de Pesquisa Clinica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Instituto Brasil de Pesquisa Clínica - IBPCLIN
City
Rio de Janeiro
ZIP/Postal Code
20241180
Country
Brazil
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Nangang District
ZIP/Postal Code
150001
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
ZIP/Postal Code
102202
Country
China
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 035
Country
India
Facility Name
Gujarat Endocrine Center
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Grant Medical College & Sir J.J. Group of Hospitals
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
ILS Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700064
Country
India
Facility Name
Fortis Hospital
City
Delhi
ZIP/Postal Code
110088
Country
India
Facility Name
OCROM Clinic
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
AMC nishi-umeda clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Ctro Inv en Artritis y Osteoporosis SC
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
Centro Especializado en Diabetes Obesidad y Enfermedades
City
Mexico
State/Province
D.f.
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Virgen Cardiovascular Research S.C
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Inst. de Diabetes, Obesidad y Nutricion S.C
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro Para el Desarrollo de la Medicina y de Asistencia Med
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Investigacion en Salud y Metabolismo S.C
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Distrito Federal
ZIP/Postal Code
3100
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Manati Center for Clinical Research Inc
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Ponce School of Medicine CAIMED Center
City
Ponce
ZIP/Postal Code
00716
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
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Consultorio Medico
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
FSBI Scientific Research Institution of Therapy of Siberian Branch of RAMS
City
Novosibirsk
State/Province
Novosibirsk Region
ZIP/Postal Code
630089
Country
Russian Federation
Facility Name
City Hospital #38 n. a. N.A. Semashko
City
St. Petersburg
State/Province
Pushkin
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Regional Public Health Institution "Cardiology Dispensary"
City
Ivanovo
ZIP/Postal Code
153012
Country
Russian Federation
Facility Name
BHI of Republic Udmurtiya "City clinical hospital #9 of Ministry of healthcare of Republic Udmurtiya"
City
Izhevsk
ZIP/Postal Code
426063
Country
Russian Federation
Facility Name
Clinical Trials Center of Medical Institute
City
Kaliningrad
ZIP/Postal Code
236035
Country
Russian Federation
Facility Name
FSBI "National Medical Research Center for Preventive Medicine" of MOH of Russian Fed
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
FSBI Endocrinological Research Center of the MOH of the ROF
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
FSBI "National Medical Research Center of Cardiology" of MOH of Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi-Mei Medical Center
City
Tainan City
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
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 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
http://vivli.org/
Citations:
PubMed Identifier
35658024
Citation
Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1o8ZY82Yn01Z4Hqvx0WuME
Description
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Learn more about this trial

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

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