A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2539
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1060ABN
      • CEDIC
    • Caba, Buenos Aires, Argentina, 1023
      • STAT Research S.A.
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BUB
      • Consultorio de Investigacion Clinica EMO SRL
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1056
      • Centro de Investigaciones Metabólicas (CINME)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clinicas Mar del Plata
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • DIM Clinica Privada
    • San Nicolás, Buenos Aires, Argentina, 2900
      • Go Centro Medico San Nicolás
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1120AAC
      • Centro Medico Viamonte
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
      • Mautalen Salud e Investigación
• Brazil
  • Rio de Janeiro, Brazil, 22241-180
    • Instituto Brasil de Pesquisa Clínica - IBPCLIN
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clínica
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigacao Clinica
  • São Paulo, Brazil, 01228-200
    • CPCLIN
  • São Paulo, Brazil, 05403-000
    • Hospital da Clinicas da Faculdade de Medicina da USP
  • Espírito Santo
    • Vitoria, Espírito Santo, Brazil, 29055-450
      • CEDOES
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-080
      • Instituto de Pesquisa Clinica de Campinas
    • Campinas, São Paulo, Brazil, 13092-133
      • Loema - Instituto de Pesquisa Clínica
• China
  • Beijing
    • Changping, Beijing, China, 102202
      • Beijing Tsinghua Changgung Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
• India
  • Delhi, India, 110088
    • Fortis Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • Gujarat Endocrine Center
  • Maharashtra
    • Mumbai, Maharashtra, India, 400008
      • Sir J.J. Group of Hospitals
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital & Research Centre
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Care Hospitals Hyderabad- Banjara Hills
  • West Bengal
    • Kolkata, West Bengal, India, 700064
      • ILS Hospital
• Japan
  • Osaka, Japan, 530-0001
    • AMC Nishiumeda Clinic
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Medical Corporation Chiseikai Tokyo Center Clinic
• Mexico
  • Chihuahua, Mexico, 31217
    • Investigacion en Salud y Metabolismo S.C
  • Veracruz, Mexico, 91910
    • Arké SMO S.A de C.V
  • Baja California
    • Mexicali, Baja California, Mexico, 21200
      • Centro de Investigacion en Artritis y Osteoporosis SC
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 11650
      • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
    • Mexico City, Distrito Federal, Mexico, 3100
      • RM Pharma Specialists
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Unidad de Investigación Clínica y Atención Médica HEPA
    • Guadalajara, Jalisco, Mexico, 44670
      • Virgen Cardiovascular Research S.C
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62250
      • Instituto de Diabetes, Obesidad y Nutricion
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Sinaloa
    • Culiacan Rosales, Sinaloa, Mexico, 80230
      • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Manati Center for Clinical Research
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC- Hato Rey Site
  • San Juan, Puerto Rico, 00921
    • Private Practice - Dr. Luis Rivera Colon
• Russian Federation
  • Ivanovskaya Oblast'
    • Ivanovo, Ivanovskaya Oblast', Russian Federation, 153012
      • Ivanovo Regional Healthcare Institution Cardiology Dispensary
  • Kaliningradskaya Oblast'
    • Kaliningrad, Kaliningradskaya Oblast', Russian Federation, 236041
      • Immanuel Kant Baltic Federal University
  • Moskva
    • Moscow, Moskva, Russian Federation, 117036
      • Endocrinology Research Center of Rosmedtechnologies
    • Moscow, Moskva, Russian Federation, 121552
      • Russian Cardiology Research and Production Complex
    • Moscow, Moskva, Russian Federation, 117997
      • Pirogov Russian National Research Medical University
    • Moscow, Moskva, Russian Federation, 127051
      • State Research Center for Preventive Medicine
  • Novosibirskaya Oblast'
    • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630089
      • Research Institute of Therapy and Preventive Medicine
  • Sankt-Peterburg
    • St. Petersburg, Sankt-Peterburg, Russian Federation, 196601
      • St Petersburg SBHI City Hospital No. 38 Named After Semashko
  • Udmurtskaya Respublika
    • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426063
      • Izhevsk City Clinical Hospital Number 9
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Tainan
    • Tainan City, Tainan, Taiwan, 71004
      • Chi-Mei Medical Center
  • Taipei
    • Taipei City, Taipei, Taiwan, 10002
      • National Taiwan University Hospital
• United States
  • Alabama
    • Pelham, Alabama, United States, 35124
      • Cahaba Research
  • Arizona
    • Scottsdale, Arizona, United States, 85224
      • Perseverance Research Center
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Clinical Research Center
    • Fresno, California, United States, 93720
      • Valley Research
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
    • Suwanee, Georgia, United States, 30024
      • Herman Clinical Research
    • Union City, Georgia, United States, 30291
      • SKY Integrative Medical Center/SKYCRNG
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Diabetes & Endocrinology
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center Sunset
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Medical Center
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Cleveland
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Alliance for Multispecialty Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine & Associates
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greer, South Carolina, United States, 29651
      • Mountain View Clinical Research, Inc.
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-ClinSearch, LLC
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology, P.A.
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Dallas, Texas, United States, 75231
      • Research Institute Of Dallas
    • Dallas, Texas, United States, 75231
      • North Texas Endocrine Center
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology, P.A.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks.; Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.; Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Placebo; Administered SC
Experimental: 5 mg Tirzepatide; Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.; Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176.; Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 10 mg Tirzepatide; Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.; Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176.; Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.; Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176.; Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight (Primary Treatment Period)	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
Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)	Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.	Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period	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
Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)	Percentage of Participants who Achieve ≥10% Body Weight Reduction	Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)	Percentage of participants who achieve ≥15% body weight reduction.	Week 72
Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)	Percentage of participants who achieve ≥20% body weight reduction.	Week 72
Change From Baseline in Waist Circumference (Primary Treatment Period)	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
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) - Primary Treatment Period	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
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	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
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	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
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	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
Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)	LS Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 176
Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)	The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported. Time to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.	Baseline through Week 176
Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)	The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported. Time to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.	Baseline through Week 193
Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period	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
Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period	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
Change From Baseline in Fasting Glucose (Primary Treatment Period)	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
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	Results are reported as model-based estimate and SE from MMRM analysis using log transformation.	Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period	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
Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)	Percentage of Participants Who Achieve ≥5% Body Weight Reduction.	Week 176
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 (Primary Treatment Period)	The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcomes (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
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): July 6, 2024

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prediabetes; Metabolism and Nutrition Disorder
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 17244; I8F-MC-GPHK (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No