ObesityPhase 3SURMOUNT-3NCT04657016
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 65 sites in 4 countries.
Trial summary
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- 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
- 579 participants
- Where
- 65 sitesin 4 countries
- Study dates
- 29 Mar 2021to 12 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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
65 sites in 4 countries.
65 sites in 4 countries
United States45 sites
American Health Network of IN, LLC
Avon, Indiana, 46123
The National Diabetes & Obesity Research Institute
Biloxi, Mississippi, 39532
Elite Clinical Trials
Blackfoot, Idaho, 83221
Holston Medical Group
Bristol, Tennessee, 37620
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
Cleveland Clinic Foundation
Cleveland, Ohio, 44122
Clinical Research of South Florida
Coral Gables, Florida, 33134
Dallas Diabetes Research Center
Dallas, Texas, 75230
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201
American Health Network of IN, LLC
Franklin, Indiana, 46131
PharmQuest
Greensboro, North Carolina, 27408
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Juno Research
Houston, Texas, 77040
National Research Institute - Huntington Park
Huntington Park, California, 90255
Detweiler Family Medicine & Associates
Lansdale, Pennsylvania, 19446
Palm Research Center Sunset
Las Vegas, Nevada, 89148
National Research Institute - Wilshire
Los Angeles, California, 90057
Tandem Clinical Research,LLC
Marrero, Louisiana, 70072
Solaris Clinical Research
Meridian, Idaho, 83646
Southern Endocrinology Associates
Mesquite, Texas, 75149
New Horizon Research Center
Miami, Florida, 33165
Catalina Research Institute, LLC
Montclair, California, 91763
American Health Network of IN, LLC
Muncie, Indiana, 47304
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Intend Research, LLC
Norman, Oklahoma, 73069
Quality Clinical Research
Omaha, Nebraska, 68114
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243
Summit Research Network
Portland, Oregon, 97210
Elite Clinical Trials
Rexburg, Idaho, 83440
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681
National Research Institute (NRI) - Santa Ana
Santa Ana, California, 92704
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Clinvest Research LLC
Springfield, Missouri, 65810
Precision Clinical Research
Sunrise, Florida, 33351
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Clinical Research of West Florida
Tampa, Florida, 33606
Cotton O'Neil Mulvane
Topeka, Kansas, 66606
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, 27157
Argentina9 sites
Glenny Corp
Buenos Aires, Ciudad Autónoma de Buenos Aire, 1430
Instituto Médico Especializado (IME)
Buenos Aires, 1405
CEMEDIAB
C.a.b.a., Ciudad Autónoma de Buenos Aire, C1205AAO
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC
Investigaciones Medicas Imoba Srl
CABA, Buenos Aires, C1179AAB
Instituto Centenario
CABA, Buenos Aires, C1204AAD
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056
Stat Research S.A.
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1023AAB
Sanatorio Norte
Santiago del Estero, 4200
Brazil8 sites
Cline Research Center
Curitiba, Paraná, 80030-480
Quanta Diagnóstico e Terapia
Curitiba, Paraná, 80040-110
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 22241-180
CPCLIN
São Paulo, São Paulo, 01228-200
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, São Paulo, 03325-050
CPQuali Pesquisa Clínica
São Paulo, 01228-000
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
CEDOES
Vitória, Espírito Santo, 29055450
Puerto Rico3 sites
Advanced Clinical Research, LLC
Bayamón, 00961
Manati Center for Clinical Research
Manati, 00674
Ponce Medical School Foundation Inc.
Ponce, 00716
About this study
Official title: Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
- Conditions
- Obesity, Overweight
- Being tested
- Tirzepatide, Placebo
- Keywords
- Diet, Exercise, Metabolism and Nutrition Disorder, Behavioral Modification
- Medical subject headings
- Obesity, Overweight, Motor Activity, Nutrition Disorders
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
PlaceboOther
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants received matching placebo SC once weekly (QW). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.
Measured: Week 72
Secondary outcomes (20)
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Measured: 72 Weeks
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Measured: 72 Weeks
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Measured: 72 Weeks
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Measured: 72 Weeks
Change From Baseline in Waist Circumference
Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Body Weight
Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Body Mass Index (BMI)
Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Diastolic Blood Pressure (DBP)
Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol
Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol
Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Triglycerides
Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Free Fatty Acids
Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Fasting Glucose
Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
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 determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Percent Change From Baseline in Fasting Insulin
Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, 72 Weeks
Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score
The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 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" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.
LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.
Measured: Baseline, 72 Weeks
Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life.
LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.
Measured: Baseline, 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start29 Mar 2021
- Primary completion20 Apr 2023
- Study completion12 May 2023
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 (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 579 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
- NCT04657016
- Sponsor's protocol ID
- 17246
- Other IDs
- I8F-MC-GPHM
- Acronym
- SURMOUNT-3
- Status last verified
- May 2024
- First submitted
- 1 Dec 2020
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Galindo 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 41885866Almandoz JP, Pickett-Blakely O, Tewksbury C, Stefanski A, Gonsahn-Bollie S, Dimitriadis GK, Murro AL, Cao D, Meng Q, Neff LM. Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Obes Pillars. 2026 Jan 23;17:100248. doi: 10.1016/j.obpill.2026.100248. eCollection 2026 Mar.
PubMed 41640675Wadden 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 40717199Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15.
PubMed 37840095
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
- ClinicalTrials.gov ID
- NCT04657016
- Acronym / sponsor ID
- SURMOUNT-3 / 17246
- Conditions
- Obesity, Overweight
- Keywords
- Diet, Exercise, Metabolism and Nutrition Disorder, Behavioral Modification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received matching placebo SC once weekly (QW). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
- History of at least one unsuccessful dietary effort to lose body weight
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide |
| PlaceboAdministered SC | Other | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight
Time frame: Baseline, 72 Weeks
Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
Time frame: Week 72
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.
20 secondary outcomes
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program
Time frame: 72 Weeks
Percentage of Participants Who Achieve ≥10%Body Weight Reduction
Time frame: 72 Weeks
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: 72 Weeks
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time frame: 72 Weeks
Change From Baseline in Waist Circumference
Time frame: Baseline, 72 Weeks
Change From Baseline in Body Weight
Time frame: Baseline, 72 Weeks
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, 72 Weeks
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, 72 Weeks
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Total Cholesterol
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Triglycerides
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Free Fatty Acids
Time frame: Baseline, 72 Weeks
Change From Baseline in Fasting Glucose
Time frame: Baseline, 72 Weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 72 Weeks
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, 72 Weeks
Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score
Time frame: Baseline, 72 Weeks
Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame: Baseline, 72 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41885866Galindo 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.
- Derived from this study: PubMed 41640675Almandoz JP, Pickett-Blakely O, Tewksbury C, Stefanski A, Gonsahn-Bollie S, Dimitriadis GK, Murro AL, Cao D, Meng Q, Neff LM. Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Obes Pillars. 2026 Jan 23;17:100248. doi: 10.1016/j.obpill.2026.100248. eCollection 2026 Mar.
- Derived from this study: PubMed 41537305Wadden 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.
- Derived from this study: PubMed 41187013Li 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.
- Derived from this study: PubMed 40717199Gourgari 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.
- Derived from this study: PubMed 37840095Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15.
- A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
65 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 65 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Argentina, Brazil, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight (time frame: Baseline, 72 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657016, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.