NCT04184622CompletedPhase 3
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
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)
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2539 (actual)
- First submitted
- 2 Dec 2019
- Start date
- 4 Dec 2019
- Primary completion date
- 1 Apr 2022
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04184622
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2539
- From 4 Dec 2019 to the primary completion date, 1 Apr 2022
- 118 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in body weight greater than 5 kg within 3 months prior to starting study
Other illness
- Diabetes mellitus
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (118)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CEDIC Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Stat Research S.A. Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Consultorio de Investigación Clínica EMO SRL Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| DIM Clínica Privada Coordinator of this site? Confirm its status | Ramos Mejía | Argentina | Unknown status |
| Go Centro Medico San Nicolas Coordinator of this site? Confirm its status | San Nicolás de los Arroyos | Argentina | Unknown status |
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Loema Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Instituto Brasil de Pesquisa Clinica (IBPClin) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital da Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Changping | China | Unknown status |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The First Affiliated Hospital of Xi'an Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Gujarat Endocrine Center Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Fortis Hospital Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| Care Hospitals Hyderabad- Banjara Hills Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| ILS Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Sir J.J. Group of Hospitals Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Deenanath Mangeshkar Hospital & Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Medical Corporation Chiseikai Tokyo Center Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| AMC Nishiumeda Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Medical Corporation Heishinkai OCROM Clinic Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Investigacion en Salud y Metabolismo S.C Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Instituto de Diabetes, Obesidad y Nutricion Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Unidad de Investigación Clinica y atencion Medica HEPA Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Virgen Cardiovascular Research S.C Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Centro de Investigacion en Artritis y Osteoporosis SC Coordinator of this site? Confirm its status | Mexicali | Mexico | Unknown status |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| RM Pharma Specialists Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Manati Center for Clinical Research Coordinator of this site? Confirm its status | Manati | Puerto Rico | Unknown status |
| Ponce Medical School Foundation Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Private Practice - Dr. Luis Rivera Colon Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Latin Clinical Trial Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Ivanovo Regional Healthcare Institution Cardiology Dispensary Coordinator of this site? Confirm its status | Ivanovo | Russia | Unknown status |
| Izhevsk City Clinical Hospital Number 9 Coordinator of this site? Confirm its status | Izhevsk | Russia | Unknown status |
| Immanuel Kant Baltic Federal University Coordinator of this site? Confirm its status | Kaliningrad | Russia | Unknown status |
| Endocrinology Research Center of Rosmedtechnologies Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Pirogov Russian National Research Medical University Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Russian Cardiology Research and Production Complex Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| State Research Center for Preventive Medicine Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Research Institute of Therapy and Preventive Medicine Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| St Petersburg SBHI City Hospital No. 38 Named After Semashko Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Chi Mei Medical Center Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| WR-ClinSearch, LLC Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Velocity Clinical Research, Cleveland Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Aventiv Research Inc Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| John Muir Physician Network Clinical Research Center Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| North Texas Endocrine Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Research Institute Of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clinical Research, Providence Coordinator of this site? Confirm its status | East Greenwich | United States | Unknown status |
| NECCR PrimaCare Research Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Lillestol Research Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Center for Advanced Research & Education Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| PharmQuest Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Mountain View Clinical Research, Inc. Coordinator of this site? Confirm its status | Greer | United States | Unknown status |
| East-West Medical Research Institute Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Midwest Institute for Clinical Research Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Detweiler Family Medicine & Associates Coordinator of this site? Confirm its status | Lansdale | United States | Unknown status |
| Palm Research Center Sunset Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| National Research Institute - Wilshire Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| L-MARC Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| ActivMed Practices and Research Coordinator of this site? Confirm its status | Methuen | United States | Unknown status |
| Suncoast Research Group Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Catalina Research Institute, LLC Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Coastal Carolina Research Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Oviedo Medical Research Coordinator of this site? Confirm its status | Oviedo | United States | Unknown status |
| Cahaba Research Coordinator of this site? Confirm its status | Pelham | United States | Unknown status |
| Summit Research Network Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rochester Clinical Research, LLC Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
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| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
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| Chase Medical Research, LLC Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
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Related publications
- Evaluation of clinical relevance of weight nadirs and weight regain during 3 years of treatment with tirzepatide in participants with obesity or overweight and prediabetes.Obes Pillars · 2026 · PMID 42831032
- Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials.Diabetes Obes Metab · 2026 · PMID 42348366
- Comprehensive Long-Term Changes in Cardiovascular Risk Biomarkers With Tirzepatide: A SURMOUNT-1 Post Hoc Analysis.J Am Coll Cardiol · 2026 · PMID 42233927
- Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials.JAMA Netw Open · 2026 · PMID 41885866
- Efficacy and Safety of Tirzepatide in Japanese Participants With Obesity: A Subpopulation Analysis of the SURMOUNT-1 Trial.Obesity (Silver Spring) · 2026 · PMID 41612966
- Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT.Obesity (Silver Spring) · 2026 · PMID 41537305
This page is information, not medical advice. Discuss any trial with your doctor.