OverweightPhase 3SURMOUNT-1NCT04184622
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
A Phase 3 study testing Tirzepatide in people with Overweight and Obesity, run by Eli Lilly and Company at 118 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,539 participants
- Where
- 118 sitesin 10 countries
- Study dates
- 4 Dec 2019to 6 Jul 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
118 sites in 10 countries.
118 sites in 10 countries
United States54 sites
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122
Aventiv Research Inc
Columbus, Ohio, 43213
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Dallas Diabetes Research Center
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
Research Institute of Dallas
Dallas, Texas, 75231
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
Lillestol Research
Fargo, North Dakota, 58104
Valley Research
Fresno, California, 93720
Center for Advanced Research & Education
Gainesville, Georgia, 30501
PharmQuest
Greensboro, North Carolina, 27408
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Detweiler Family Medicine & Associates
Lansdale, Pennsylvania, 19446
Palm Research Center Sunset
Las Vegas, Nevada, 89148
National Research Institute - Wilshire
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
Southern Endocrinology Associates
Mesquite, Texas, 75149
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Suncoast Research Group
Miami, Florida, 33135
New Horizon Research Center
Miami, Florida, 33165
Catalina Research Institute, LLC
Montclair, California, 91763
Yale University School of Medicine
New Haven, Connecticut, 06519
NYU Langone Health
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10021
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Renstar Medical Research
Ocala, Florida, 34471
Oviedo Medical Research
Oviedo, Florida, 32765
Cahaba Research
Pelham, Alabama, 35124
Summit Research Network
Portland, Oregon, 97210
Rochester Clinical Research, LLC
Rochester, New York, 14609
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681
Perseverance Research Center
Scottsdale, Arizona, 85224
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Clinvest Research LLC
Springfield, Missouri, 65807
Herman Clinical Research
Suwanee, Georgia, 30024
ForCare Clinical Research
Tampa, Florida, 33613
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Premier Research
Trenton, New Jersey, 08611
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
University Clinical Investigators, Inc.
Tustin, California, 92780
SKY Integrative Medical Center/SKYCRNG
Union City, Georgia, 30291
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Mexico10 sites
Investigacion en Salud y Metabolismo S.C
Chihuahua City, 31217
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230
Unidad de Investigacion Clinica y Atencion Medica HEPA
Guadalajara, Jalisco, 44670
Virgen Cardiovascular Research S.C
Guadalajara, Jalisco, 44670
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, 21200
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650
RM Pharma Specialists
Mexico City, Mexico City, 3100
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Arké SMO S.A de C.V
Veracruz, 91910
Argentina9 sites
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF
Stat Research S.A.
CABA, Buenos Aires, 1023
CEDIC
CABA, Buenos Aires, C1060ABN
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
DIM Clinica Privada
Ramos Mejía, Buenos Aires, 1704
GO Centro Médico San Nicolás
San Nicolás de los Arroyos, Buenos Aires, 2900
Russia9 sites
Ivanovo Regional Healthcare Institution Cardiology Dispensary
Ivanovo, Ivanovo Oblast, 153012
Izhevsk City Clinical Hospital Number 9
Izhevsk, Udmurtiya Republic, 426063
Immanuel Kant Baltic Federal University
Kaliningrad, Kaliningrad Oblast, 236041
Endocrinology Research Center of Rosmedtechnologies
Moscow, Moscow, 117036
Pirogov Russian National Research Medical University
Moscow, Moscow, 117997
Russian Cardiology Research and Production Complex
Moscow, Moscow, 121552
State Research Center for Preventive Medicine
Moscow, Moscow, 127051
Research Institute of Therapy and Preventive Medicine
Novosibirsk, Novosibirsk Oblast, 630089
St Petersburg SBHI City Hospital No. 38 Named After Semashko
Saint Petersburg, Sankt-Peterburg, 196601
Brazil8 sites
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080
Loema - Instituto de Pesquisa Clinica
Campinas, São Paulo, 13092-133
Instituto Brasil de Pesquisa Clínica - IBPCLIN
Rio de Janeiro, 22241-180
CPQuali Pesquisa Clínica
São Paulo, 01228-000
CPCLIN
São Paulo, 01228-200
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
CEDOES
Vitória, Espírito Santo, 29055-450
China7 sites
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, 102202
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Jinan Central Hospital
Jinan, Shandong, 250013
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Ningbo First Hospital
Ningbo, Zhejiang, 315010
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077
India6 sites
Gujarat Endocrine Center
Ahmedabad, Gujarat, 380006
Fortis Hospital
Delhi, 110088
Care Hospitals Hyderabad- Banjara Hills
Hyderabad, Telangana, 500034
ILS Hospital
Kolkata, West Bengal, 700064
Sir J.J. Group of Hospitals
Mumbai, Maharashtra, 400008
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Japan5 sites
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
AMC Nishiumeda Clinic
Osaka, 530-0001
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
Puerto Rico5 sites
Manati Center for Clinical Research
Manati, 00674
Ponce Medical School Foundation Inc.
Ponce, 00716
Latin Clinical Trial Center
San Juan, 00909
GCM Medical Group, PSC- Hato Rey Site
San Juan, 00917
Private Practice - Dr. Luis Rivera Colon
San Juan, 00921
Taiwan5 sites
Chung Shan Medical University Hospital
Taichung, 402
China Medical University Hospital
Taichung, 40447
Chi-Mei Medical Center
Tainan, Tainan, 71004
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei City, Taipei, 10002
About this study
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)
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.
- Conditions
- Overweight, Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- Metabolism and Nutrition Disorder, Prediabetes
- Medical subject headings
- Overweight, Obesity, Nutrition Disorders, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | * 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. Receives: Drug: Placebo |
| 5 mg Tirzepatide | Experimental | * 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. Receives: Drug: Tirzepatide |
| 10 mg Tirzepatide | Experimental | * 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. Receives: Drug: Tirzepatide |
| 15 mg Tirzepatide | Experimental | * 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 72
Secondary outcomes (24)
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.
Measured: Baseline, Week 20
Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Measured: Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)
Percentage of participants who achieve ≥15% body weight reduction.
Measured: Week 72
Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)
Percentage of participants who achieve ≥20% body weight reduction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start4 Dec 2019
- Primary completion1 Apr 2022
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184622
- Sponsor's protocol ID
- 17244
- Other IDs
- I8F-MC-GPHK
- Acronym
- SURMOUNT-1
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2019
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Aronne LJ, Vincent RP, Klein KR, Brumm JF, Jouravskaya I, Cao D, Dimitriadis GK, Dunn JP. 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 Sep 18;20:100333. doi: 10.1016/j.obpill.2026.100333. eCollection 2026 Dec.
PubMed 42831032Kokkinos A, Thethi T, Lee CJ, Neff LM, Stefanski A, Cao D, Rodriguez A, Bartee A. 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 Sep;28(9):8367-8377. doi: 10.1111/dom.71009. Epub 2026 Jun 25.
PubMed 42348366Sattar N, Linetzky B, Ruotolo G, Verma S, Sourij H, Wang H, Vanderman K, Wilson JM, Griffin RM, Stefanski A, Ridker PM. Comprehensive Long-Term Changes in Cardiovascular Risk Biomarkers With Tirzepatide: A SURMOUNT-1 Post Hoc Analysis. J Am Coll Cardiol. 2026 Jun 3:S0735-1097(26)06416-8. doi: 10.1016/j.jacc.2026.04.044. Online ahead of print.
PubMed 42233927Galindo RJ, Gudzune KA, Look M, Lee CJ, Benabbad I, Cao D, Meng Q, Mojdami D. Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. JAMA Netw Open. 2026 Mar 2;9(3):e263274. doi: 10.1001/jamanetworkopen.2026.3274.
PubMed 41885866Ishigaki Y, Yamada M, Shingaki T, Oura T, Shimomura I. Efficacy and Safety of Tirzepatide in Japanese Participants With Obesity: A Subpopulation Analysis of the SURMOUNT-1 Trial. Obesity (Silver Spring). 2026 Mar;34(3):608-621. doi: 10.1002/oby.70131. Epub 2026 Jan 30.
PubMed 41612966Wadden TA, Oquendo MA, Kushner RF, Cao D, Karanikas CA, Kechter A, Murphy MA. Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Obesity (Silver Spring). 2026 Mar;34(3):565-578. doi: 10.1002/oby.70122. Epub 2026 Jan 15.
PubMed 41537305Li X, Cao D, Sapin H, Wang F, Hunter Gibble T, Raibulet NK, Denning M, Kaplan LM. People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Obesity (Silver Spring). 2026 Jan;34(1):114-126. doi: 10.1002/oby.70067. Epub 2025 Nov 4.
PubMed 41187013Gourgari E, Srivastava G, Kelly AS, Mojdami D, Cao D, Murphy MA, Karanikas CA, Lee CJ. Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Obesity (Silver Spring). 2025 Sep;33(9):1668-1679. doi: 10.1002/oby.24348. Epub 2025 Jul 27.
PubMed 40717199Ard J, Lee CJ, Gudzune K, Addison B, Lingvay I, Cao D, Mast CJ, Stefanski A, Falcon B, Mojdami D. Weight reduction over time in tirzepatide-treated participants by early weight loss response: Post hoc analysis in SURMOUNT-1. Diabetes Obes Metab. 2025 Sep;27(9):5064-5071. doi: 10.1111/dom.16554. Epub 2025 Jul 17.
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