Clinical trial NCT04660643: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Keywords: Metabolism and Nutrition Disorder
Prediabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 783
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 was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).


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

Primary outcomes:
measure: Percent Change From Randomization in Body Weight at Week 88
timeFrame: Randomization (Week 36), Week 88
Secondary outcomes:
measure: Percent Change From Randomization in Body Weight at Week 64
timeFrame: Randomization (Week 36), Week 64
measure: Change From Randomization in Body Weight
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Waist Circumference
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Body Mass Index (BMI)
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Fasting Glucose
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Hemoglobin A1c (HbA1c)
timeFrame: Randomization (Week 36), Week 88
measure: Percent Change From Randomization in Fasting Insulin
timeFrame: Randomization (Week 36), Week 88
measure: Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA))
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score
timeFrame: Randomization (Week 36), Week 88
measure: Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score
timeFrame: Randomization (Week 36), Week 88
measure: Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period
timeFrame: Week 88
measure: Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline
timeFrame: Baseline (Week 0) to Week 88
measure: Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period
timeFrame: Randomization (Week 36) to Week 88
measure: Change From Baseline in BMI
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in Body Weight
timeFrame: Baseline (Week 0), Week 88
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in HbA1c
timeFrame: Baseline (Week 0), Week 88
measure: Percent Change From Baseline in Fasting Insulin
timeFrame: Baseline (Week 0), Week 88
measure: Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in SBP, DBP
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score
timeFrame: Baseline (Week 0), Week 88
measure: Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score
timeFrame: Baseline (Week 0), Week 88
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research
state: Alabama
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Golden
country: United States
facility: New West Physicians Clinical Research
state: Colorado
city: Monument
country: United States
facility: Optumcare Colorado Springs - Monument
state: Colorado
city: Jacksonville
country: United States
facility: Care Partners Clinical Research
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Union City
country: United States
facility: SKY Clinical Research Network Group-Blake
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research
state: Indiana
city: New Albany
country: United States
facility: American Health Network of Indiana, LLC - New Albany
state: Indiana
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Hyattsville
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute - Endocrinology
state: Montana
city: New York
country: United States
facility: Weill Cornell Medical College
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: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Columbus
country: United States
facility: Aventiv Research Inc
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: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Médico Viamonte
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: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aire
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aire
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Cline Research Center
state: Paraná
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Sao Paulo
country: Brazil
facility: BR Trials - Ensaios Clinicos e Consultoria
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
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: Bayamon
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara Gonzalez
city: San Juan
country: Puerto Rico
facility: Private Practice Dr. Martha Gomez Cuellar
city: Vega Baja
country: Puerto Rico
facility: Wellness clinical Research Vega Baja
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung Uni. Hosp.
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
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: