A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Obesity Clinical Trial

— SURMOUNT-1  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04184622
• Other study ID #: 17244
• Secondary ID: I8F-MC-GPHK
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 4, 2019
• Est. completion date: July 8, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2539
• Est. completion date: July 8, 2024
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEDIC	Caba	Buenos Aires
Argentina	Stat Research S.A.	Caba	Buenos Aires
Argentina	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	DIM Clinica Privada	Ramos Mejía	Buenos Aires
Argentina	GO Centro Médico San Nicolás	San Nicolás	Buenos Aires
Brazil	Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo
Brazil	Loema - Instituto de Pesquisa Clinica	Campinas	São Paulo
Brazil	Instituto Brasil de Pesquisa Clínica - IBPCLIN	Rio de Janeiro
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPCLIN	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	Hospital da Clinicas da Faculdade de Medicina da USP	São Paulo
Brazil	CEDOES	Vitoria	Espírito Santo
China	Beijing Tsinghua Changgung Hospital	Changping	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Jinan Central Hospital	Jinan	Shandong
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shanxi
India	Gujarat Endocrine Center	Ahmedabad	Gujarat
India	Fortis Hospital	Delhi
India	Care Hospitals Hyderabad- Banjara Hills	Hyderabad	Telangana
India	ILS Hospital	Kolkata	West Bengal
India	Sir J.J. Group of Hospitals	Mumbai	Maharashtra
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Mexico	Investigacion en Salud y Metabolismo S.C	Chihuahua
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacan Rosales	Sinaloa
Mexico	Unidad de Investigacion Clinica y Atencion Medica HEPA	Guadalajara	Jalisco
Mexico	Virgen Cardiovascular Research S.C	Guadalajara	Jalisco
Mexico	Centro de Investigacion en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Puerto Rico	Manati Center for Clinical Research	Manati
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	GCM Medical Group, PSC- Hato Rey Site	San Juan
Puerto Rico	Latin Clinical Trial Center	San Juan
Puerto Rico	Private Practice - Dr. Luis Rivera Colon	San Juan
Russian Federation	Ivanovo Regional Healthcare Institution Cardiology Dispensary	Ivanovo	Ivanovskaya Oblast'
Russian Federation	Izhevsk City Clinical Hospital Number 9	Izhevsk	Udmurtskaya Respublika
Russian Federation	Immanuel Kant Baltic Federal University	Kaliningrad	Kaliningradskaya Oblast'
Russian Federation	Endocrinology Research Center of Rosmedtechnologies	Moscow	Moskva
Russian Federation	National Medical Research Center for therapy and preventive medicine	Moscow	Moskva
Russian Federation	Pirogov Russian National Research Medical University	Moscow	Moskva
Russian Federation	Russian Cardiology Research and Production Complex	Moscow	Moskva
Russian Federation	Research Institute of Therapy and Preventive Medicine	Novosibirsk	Novosibirskaya Oblast'
Russian Federation	St Petersburg SBHI City Hospital No. 38 Named After Semashko	St. Petersburg	Sankt-Peterburg
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Medical Center	Tainan City	Tainan
Taiwan	Chi-Mei Medical Center	Tainan City	Tainan
Taiwan	National Taiwan University Hospital	Taipei City	Taipei
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	WR-Clinsearch, LLC	Chattanooga	Tennessee
United States	Rapid Medical Research	Cleveland	Ohio
United States	Aventiv Research Inc	Columbus	Ohio
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Lillestol Research	Fargo	North Dakota
United States	Valley Research	Fresno	California
United States	Center for Advanced Research & Education	Gainesville	Georgia
United States	PharmQuest	Greensboro	North Carolina
United States	Mountain View Clinical Research, Inc.	Greer	South Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Detweiler Family Medicine & Associates	Lansdale	Pennsylvania
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	National Research Institute - Wilshire	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	NYU Langone Health	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Intend Research, LLC	Norman	Oklahoma
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Renstar Medical Research	Ocala	Florida
United States	Oviedo Medical Research	Oviedo	Florida
United States	Cahaba Research	Pelham	Alabama
United States	Summit Headlands	Portland	Oregon
United States	SKY Clinical Research Network Group-Quinn	Ridgeland	Mississippi
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Perseverance Research Center	Scottsdale	Arizona
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	Herman Clinical Research	Suwanee	Georgia
United States	ForCare Clinical Research	Tampa	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Premier Research	Trenton	New Jersey
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  China,  India,  Japan,  Mexico,  Puerto Rico,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight	Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Primary	Percentage of Participants Who Achieve =5% Body Weight Reduction	Percentage of participants who achieve =5% body weight reduction.	Week 72
Secondary	Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 20
Secondary	Percent Change From Baseline in Body Weight	Percent Change from Baseline in Body Weight.	Baseline, Week 176
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction	Percentage of Participants who Achieve =10% Body Weight Reduction	Week 72
Secondary	Percentage of Participants Who Achieve =15% Body Weight Reduction	Percentage of participants who achieve =15% body weight reduction.	Week 72
Secondary	Percentage of Participants Who Achieve =5% Body Weight Reduction	Percentage of Participants who Achieve =5% Body Weight Reduction.	Week 176
Secondary	Percentage of Participants Who Achieve =20% Body Weight Reduction	Percentage of participants who achieve =20% body weight reduction.	Week 72
Secondary	Change From Baseline in Waist Circumference	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	Change From Baseline in Body Mass Index (BMI)	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	Change From Baseline in Fasting Glucose	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Time to Onset of Type 2 Diabetes	Time to Onset of Type 2 Diabetes	Baseline through Week 176
Secondary	Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Secondary	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)	The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.	Baseline, Week 72
Secondary	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	The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.	Baseline, Week 72
Secondary	Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide	PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.	Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

External Links

•   A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight