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)
Who is this study for? Adult patients with obesity but without diabetes
What treatments are being studied? Tirzepatide
Status: Completed
Location: See all (70) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Cahaba Research
Pelham
California
Scripps Memorial Hospital La Jolla
La Jolla
National Research Institute - Wilshire
Los Angeles
National Research Institute
Panorama City
Artemis Institute for Clinical Research
San Diego
University Clinical Investigators, Inc.
Tustin
Colorado
New West Physicians Clinical Research
Golden
Optumcare Colorado Springs - Monument
Monument
Florida
Care Partners Clinical Research
Jacksonville
South Florida Clinical Research Institute
Margate
Renstar Medical Research
Ocala
ForCare Clinical Research
Tampa
Georgia
Endocrine Research Solutions, Inc.
Roswell
SKY Clinical Research Network Group-Blake
Union City
Hawaii
East-West Medical Research Institute
Honolulu
Idaho
Rocky Mountain Clinical Research
Idaho Falls
Illinois
Healthcare Research Network - Chicago
Flossmoor
Clinical Investigation Specialists
Gurnee
Indiana
Midwest Institute For Clinical Research
Indianapolis
American Health Network of Indiana, LLC - New Albany
New Albany
Kansas
Cotton O'Neil Clinic
Topeka
Kentucky
L-MARC Research Center
Louisville
Massachusetts
ActivMed Practices and Research
Methuen
Maryland
Centennial Medical Group
Elkridge
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy
Missouri
StudyMetrix Research
Saint Peters
Montana
Glacier View Research Institute - Endocrinology
Kalispell
North Carolina
University of North Carolina Medical Center
Chapel Hill
PharmQuest
Greensboro
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-salem
North Dakota
Lillestol Research
Fargo
New York
Weill Cornell Medical College
New York
Ohio
Aventiv Research Inc
Columbus
Oklahoma
Intend Research, LLC
Norman
Oregon
Summit Research Network
Portland
Pennsylvania
Capital Area Research, LLC
Camp Hill
South Carolina
Tribe Clinical Research, LLC
Greenville
Texas
The University of Texas Health Science Center at Houston
Bellaire
Dallas Diabetes Research Center
Dallas
North Texas Endocrine Center
Dallas
Biopharma Informatic, LLC
Houston
North Hills Family Medicine/North Hills Medical Research
North Richland Hills
Clinical Trials of Texas, Inc.
San Antonio
Northwest Houston Heart Center
Tomball
Virginia
Health Research of Hampton Roads, Inc.
Newport News
Washington
Capital Clinical Research Center
Olympia
Rainier Clinical Research Center
Renton
Other Locations
Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires
Mautalen Salud e Investigación
Buenos Aires
CEDIC
Caba
Centro Médico Viamonte
Caba
Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma De Buenos Aire
Stat Research S.A.
Ciudad Autónoma De Buenos Aire
Instituto Médico Catamarca IMEC
Rosario
Brazil
Centro de Pesquisa Sao Lucas
Campinas
Cline Research Center
Curitiba
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio De Janeiro
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José Dos Campos
BR Trials - Ensaios Clinicos e Consultoria
Sao Paulo
CPQuali Pesquisa Clínica
São Paulo
CEDOES
Vitória
Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
Bayamon
Private Practice Dr. Martha Gomez Cuellar
San Juan
Wellness clinical Research Vega Baja
Vega Baja
Taiwan
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
National Cheng-Kung Uni. Hosp.
Tainan
National Taiwan University Hospital
Taipei
Time Frame
Start Date: 2021-03-29
Completion Date: 2023-05-18
Participants
Target number of participants: 783
Treatments
Experimental: Tirzepatide (lead-in)
Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
Experimental: Tirzepatide MTD
Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.
Placebo_comparator: Placebo
Participants received weekly doses of placebo SC for 52 weeks.
Authors
Gustavo Akerman Akerman Augusto, Gustavo Albizu, John M Agaiby, Tanya Bogle, Ronald Keith Mayfield, Juan Loy, Robert Allen Jenders, Douglas Scott Denham, Deborah Bade Horn, Lisa Connery, John Paul Nardandrea, Stacey Layle, Eric J. Klein, Altagracia A Alcantara-Gonzalez, David Fitz-Patrick, John Gabriel, Juan Pablo Frias, Phillip D. Toth, Alan Glenn Wynne, Jean Young Park, Royce Keith Solano, Peter Edward Bressler, Leslie J Klaff, Louis J Aronne, Ronald Stumbris, Carl D Vance, Venkatesh Nadar, Athena Philis-Tsimikas, Kim M Barbel-Johnson, Julio Rosenstock, Dwight D Blake, Michael J. McCartney, Shamaila Aslam, John Chip H. Reed, Purvi K. Mehra, Alexander Vance Murray, Donald Franklin Gardner, James H. Bergthold, Jamy Ard, Sriram Machineni, Brian Terence Heimer, Cindy H. T. Pau, Neil J. Fraser, Michael J Lillestol, Michael Vaughn, Harold E. Bays, Wen-Yuan Lin, Luis Henrique Canani, Bruno Halpern, Jose Gerardo Gonzalez-Gonzalez, Danilo Villagelin, Chien-Ning Huang, Gustavo Daniel Frechtel
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company