Clinical trial NCT04657016: A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Keywords: Diet
Exercise
Metabolism and Nutrition Disorder
Behavioral Modification
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, 72 Weeks
measure: Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
timeFrame: 72 Weeks
measure: Percentage of Participants Who Achieve ≥10%Body Weight Reduction
timeFrame: 72 Weeks
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: 72 Weeks
measure: Percentage of Participants Who Achieve ≥20% Body Weight Reduction
timeFrame: 72 Weeks
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Total Cholesterol
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Triglycerides
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Free Fatty Acids
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 72 Weeks
measure: Percent Change From Baseline in Fasting Insulin
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, 72 Weeks
measure: Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
timeFrame: Baseline, 72 Weeks
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Santa Ana
country: United States
facility: National Research Institute (NRI) - Santa Ana
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Avon
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Franklin
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Muncie
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Mulvane
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research,LLC
state: Louisiana
city: Biloxi
country: United States
facility: The National Diabetes & Obesity Research Institute
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center (WFUBMC)
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Lansdale
country: United States
facility: Detweiler Family Medicine & Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Health One Hundred Oaks
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Caba
country: Argentina
facility: Centro Médico Viamonte
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Stat Research S.A.
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Glenny Corp
state: Ciudad Autónoma De Buenos Aire
city: C.a.b.a.
country: Argentina
facility: CEMEDIAB
state: Ciudad Autónoma De Buenos Aire
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Cline Research Center
state: Paraná
city: Curitiba
country: Brazil
facility: Quanta Diagnóstico e Terapia
state: Paraná
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: Sao Paulo
country: Brazil
facility: BR Trials - Ensaios Clinicos e Consultoria
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: