SURMOUNT-3

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

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)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

579

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04657016

Org study ID17246

Secondary IDI8F-MC-GPHMEli Lilly and Company

Timeline

Milestones

Study first posted2020-12-07actual

Study start2021-03-29actual

Primary completion2023-04-20actual

Study completion2023-05-12actual

Last update posted2024-05-16actual

Results first posted2024-05-16actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

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

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

18 endpoints

Primary/registry result

Percent Change From Baseline in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	3.3	—
Tirzepatide	-21.1	—

Mean Difference (Net)-24.595% CI-26.1 – -22.8p<0.001Mixed Models Analysis

Primary/registry result

Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	10.65	—
Tirzepatide	94.37	—

Odds Ratio (OR)130.3695% CI69.98 – 242.84p<0.001Regression, Logistic

Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program

Time frame:72 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	37.80	—
Tirzepatide	98.59	—

Odds Ratio (OR)101.6095% CI39.17 – 263.55p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥10%Body Weight Reduction

Time frame:72 Weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	4.81	—
Tirzepatide	88.03	—

Odds Ratio (OR)153.9595% CI78.90 – 300.37p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:72 Weeks

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Placebo	2.06	—
Tirzepatide	73.94	—

Odds Ratio (OR)144.4895% CI62.65 – 333.21p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Time frame:72 Weeks

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Placebo	1.03	—
Tirzepatide	54.93	—

Odds Ratio (OR)118.0695% CI40.08 – 347.74p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, 72 Weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centimeters (Cms)	95% CI
Placebo	1.1	—
Tirzepatide	-16.8	—

Mean Difference (Net)-17.995% CI-19.5 – -16.3p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Placebo	3.5	—
Tirzepatide	-21.5	—

Mean Difference (Net)-25.095% CI-26.9 – -23.2p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, 72 Weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram per meter square (kg/m^2)	95% CI
Placebo	1.2	—
Tirzepatide	-7.7	—

Mean Difference (Net)-8.995% CI-9.6 – -8.3p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program

Time frame:72 Weeks

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10%Body Weight Reduction

Time frame:72 Weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:72 Weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Time frame:72 Weeks

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, 72 Weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, 72 Weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change From Baseline in Fasting Glucose

Time frame:Baseline, 72 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), Milligram per deciliter (mg/dL)	95% CI
Placebo	2.4	—
Tirzepatide	-8.8	—

Mean Difference (Net)-11.295% CI-13.5 – -8.8p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 72 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Placebo	0.01	—
Tirzepatide	-0.46	—

Mean Difference (Net)-0.4795% CI-0.53 – -0.42p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, 72 Weeks

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	17.3	—
Tirzepatide	-39.1	—

Mean Difference (Net)-48.195% CI-53.7 – -41.7p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose

Time frame:Baseline, 72 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 72 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, 72 Weeks

percent change from baseline, improvement

Cardiometabolic biomarkers

16 endpoints

Secondary/registry result

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, 72 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
Placebo	4.4	—
Tirzepatide	-5.8	—

Mean Difference (Net)-10.295% CI-12.2 – -8.1p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, 72 Weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Placebo	2.3	—
Tirzepatide	-3.4	—

Mean Difference (Net)-5.795% CI-7.2 – -4.3p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Total Cholesterol

Time frame:Baseline, 72 Weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	5.19	—
Tirzepatide	-3.00	—

Mean Difference (Net)-7.7995% CI-10.40 – -5.10p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol

Time frame:Baseline, 72 Weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	3.6	—
Tirzepatide	15.4	—

Mean Difference (Net)11.495% CI8.2 – 14.7p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol

Time frame:Baseline, 72 Weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	6.14	—
Tirzepatide	-6.07	—

Mean Difference (Net)-11.5095% CI-15.30 – -7.53p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol

Time frame:Baseline, 72 Weeks

VLDL, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	3.0	—
Tirzepatide	-25.6	—

Mean Difference (Net)-27.895% CI-32.1 – -23.2p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Triglycerides

Time frame:Baseline, 72 Weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	3.0	—
Tirzepatide	-25.8	—

Mean Difference (Net)-28.095% CI-32.3 – -23.4p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Free Fatty Acids

Time frame:Baseline, 72 Weeks

Free fatty acids, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Placebo	-15.0	—
Tirzepatide	-33.1	—

Mean Difference (Net)-21.395% CI-28.4 – -13.6p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, 72 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, 72 Weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change From Baseline in Total Cholesterol

Time frame:Baseline, 72 Weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol

Time frame:Baseline, 72 Weeks

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol

Time frame:Baseline, 72 Weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol

Time frame:Baseline, 72 Weeks

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Triglycerides

Time frame:Baseline, 72 Weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Free Fatty Acids

Time frame:Baseline, 72 Weeks

Free fatty acids, change

percent change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

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

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), T-score	95% CI
Placebo	-0.6	—
Tirzepatide	3.3	—

Mean Difference (Net)3.895% CI2.8 – 4.9p<0.001ANCOVA

Secondary/registry result

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

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	95% CI
Placebo	1.1	—
Tirzepatide	13.9	—

Mean Difference (Net)12.895% CI9.7 – 16.0p<0.001ANCOVA

Secondary/protocol endpoint

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

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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

IWQOL-Lite physical

change from baseline, improvement

Publications (8)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials.
JAMA network open2026 Mar 2PMID41885866doi:10.1001/jamanetworkopen.2026.3274via clinicaltrials gov reference derived + pubmed nct search
Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT.
Obesity (Silver Spring, Md.)2026 Mar (month)PMID41537305doi:10.1002/oby.70122via clinicaltrials gov reference derived + pubmed nct search
Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials.
Obesity pillars2026 Mar (month)PMID41640675doi:10.1016/j.obpill.2026.100248via clinicaltrials gov reference derived + pubmed nct search
Achieving BMI <25 kg/m(2) was associated with reduced predicted risk of atherosclerotic cardiovascular disease in people with obesity or overweight on tirzepatide or placebo: a post hoc analysis of SURMOUNT-1, -3, and -CN.
EClinicalMedicine2026 Jan (month)PMID41536939doi:10.1016/j.eclinm.2025.103722via pubmed nct search
People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment.
Obesity (Silver Spring, Md.)2026 Jan (month)PMID41187013doi:10.1002/oby.70067via clinicaltrials gov reference derived + pubmed nct search
Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.
Obesity (Silver Spring, Md.)2025 Sep (month)PMID40717199doi:10.1002/oby.24348via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.
Nature medicine2023 Nov (month)PMID37840095doi:10.1038/s41591-023-02597-wvia clinicaltrials gov reference derived + pubmed nct search
Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program.
Obesity (Silver Spring, Md.)2023 Jan (month)PMID36478180doi:10.1002/oby.23612via pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.