Clinical trial NCT04184622: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Keywords: Metabolism and Nutrition Disorder
Prediabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 2539
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 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.


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 Baseline in Body Weight
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Week 72
Secondary outcomes:
measure: Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)
timeFrame: Baseline, Week 20
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 176
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Week 176
measure: Percentage of Participants Who Achieve ≥20% Body Weight Reduction
timeFrame: Week 72
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Time to Onset of Type 2 Diabetes
timeFrame: Baseline through Week 176
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
timeFrame: Baseline, Week 72
measure: 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)
timeFrame: Baseline, Week 72
measure: 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
timeFrame: Baseline, Week 72
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
timeFrame: Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research
state: Alabama
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fresno
country: United States
facility: Valley Research
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: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research
state: Georgia
city: Union City
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
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: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
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: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty 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: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
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: Dallas
country: United States
facility: Research Institute of Dallas
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: Caba
country: Argentina
facility: Stat Research S.A.
state: Buenos Aires
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clinica Privada
state: Buenos Aires
city: San Nicolás
country: Argentina
facility: GO Centro Médico San Nicolás
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Vitoria
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Campinas
country: Brazil
facility: Loema - Instituto de Pesquisa Clinica
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CPCLIN
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: São Paulo
country: Brazil
facility: Hospital da Clinicas da Faculdade de Medicina da USP
city: Changping
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ahmedabad
country: India
facility: Gujarat Endocrine Center
state: Gujarat
city: Mumbai
country: India
facility: Sir J.J. Group of Hospitals
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Hyderabad
country: India
facility: Care Hospitals Hyderabad- Banjara Hills
state: Telangana
city: Kolkata
country: India
facility: ILS Hospital
state: West Bengal
city: Delhi
country: India
facility: Fortis Hospital
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis SC
state: Baja California
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica y Atencion Medica HEPA
state: Jalisco
city: Guadalajara
country: Mexico
facility: Virgen Cardiovascular Research S.C
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Culiacan Rosales
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Investigacion en Salud y Metabolismo S.C
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC- Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Private Practice - Dr. Luis Rivera Colon
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Healthcare Institution Cardiology Dispensary
state: Ivanovskaya Oblast'
city: Kaliningrad
country: Russian Federation
facility: Immanuel Kant Baltic Federal University
state: Kaliningradskaya Oblast'
city: Moscow
country: Russian Federation
facility: Endocrinology Research Center of Rosmedtechnologies
state: Moskva
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research and Production Complex
state: Moskva
city: Moscow
country: Russian Federation
facility: State Research Center for Preventive Medicine
state: Moskva
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Therapy and Preventive Medicine
state: Novosibirskaya Oblast'
city: St. Petersburg
country: Russian Federation
facility: St Petersburg SBHI City Hospital No. 38 Named After Semashko
state: Sankt-Peterburg
city: Izhevsk
country: Russian Federation
facility: Izhevsk City Clinical Hospital Number 9
state: Udmurtskaya Respublika
city: Tainan City
country: Taiwan
facility: Chi-Mei Medical Center
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei
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 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:
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.