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SURMOUNT-2

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

75

Recruiting sites

Enrollment

938

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥27HbA1c 7-10%

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 IDNCT04657003
Org study ID17245
Secondary IDI8F-MC-GPHLEli Lilly and Company

Timeline

Milestones

Study first posted2020-12-07actual
Study start2021-03-29actual
Primary completion2023-03-16actual
Study completion2023-04-10actual
Last update posted2024-04-08actual
Results first posted2024-04-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
Have a BMI of ≥27 kg/m²
Are overweight or have obesity
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Are at least 18 years of age and age of majority per local laws and regulations

Exclusion criteria

Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
Have self-reported change in body weight >5kg within 3 months prior to screening
Have had a history of chronic or acute pancreatitis
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
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 (52)

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

Cardiometabolic biomarkers
18
Weight & body composition
16
Glycemic / diabetes
12
Patient-reported / QoL
4
Safety / tolerability / PK
2

Weight & body composition

16 endpoints
Primary/registry result

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percent change95% CI
Placebo-3.3
10 mg Tirzepatide-13.4
15 mg Tirzepatide-15.7
LSMean Mean Difference (Net)-10.195% CI-11.5-8.8p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-12.495% CI-13.7-11.0p<0.001Mixed Models Analysis
Primary/registry result

Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo30.55
10 mg Tirzepatide81.55
15 mg Tirzepatide86.41
Odds Ratio (OR)10.7595% CI7.3015.84p<0.001Regression, Logistic
Odds Ratio (OR)15.2895% CI10.0823.14p<0.001Regression, Logistic
Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo8.68
10 mg Tirzepatide63.43
15 mg Tirzepatide69.58
Odds Ratio (OR)20.9495% CI13.0633.58p<0.001Regression, Logistic
Odds Ratio (OR)27.5095% CI17.0444.39p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo2.57
10 mg Tirzepatide41.42
15 mg Tirzepatide51.78
Odds Ratio (OR)28.3895% CI13.8158.31p<0.001Regression, Logistic
Odds Ratio (OR)43.6095% CI21.2089.67p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo0.96
10 mg Tirzepatide22.98
15 mg Tirzepatide33.98
Odds Ratio (OR)28.5495% CI9.7383.73p<0.001Regression, Logistic
Odds Ratio (OR)49.6895% CI17.03144.94p<0.001Regression, Logistic
Secondary/registry result

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
Placebo-3.2
10 mg Tirzepatide-13.5
15 mg Tirzepatide-15.6
LSMean Mean Difference (Net)-10.395% CI-11.7-8.8p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-12.495% CI-13.8-11.0p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms per meter squared (kg/m^2)95% CI
Placebo-1.2
10 mg Tirzepatide-4.9
15 mg Tirzepatide-5.7
LSMean Mean Difference (Net)-3.795% CI-4.2-3.2p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-4.595% CI-5.0-4.0p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), centimeters (cm)95% CI
Placebo-3.4
10 mg Tirzepatide-11.2
15 mg Tirzepatide-13.8
LSMean Mean Difference (Net)-7.895% CI-9.2-6.4p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-10.495% CI-11.8-8.9p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo-0.16
10 mg Tirzepatide-2.14
15 mg Tirzepatide-2.22
LSMean Mean Difference (Net)-1.9795% CI-2.15-1.80p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-2.0695% CI-2.24-1.88p<0.001Mixed Models Analysis
Secondary/registry result

Percentage of Participants Who Achieve HbA1c <7%

Time frame:Week 72

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo29.31
10 mg Tirzepatide90.03
15 mg Tirzepatide90.67
Odds Ratio (OR)28.0195% CI17.2145.59p<0.001Regression, Logistic
Odds Ratio (OR)34.1995% CI20.2757.67p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve HbA1c ≤6.5%

Time frame:Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo15.52
10 mg Tirzepatide84.05
15 mg Tirzepatide86.67
Odds Ratio (OR)42.1195% CI25.6169.26p<0.001Regression, Logistic
Odds Ratio (OR)58.6795% CI34.29100.37p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve HbA1c <5.7%

Time frame:Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo2.76
10 mg Tirzepatide50.17
15 mg Tirzepatide55.33
Odds Ratio (OR)42.5595% CI20.4688.50p<0.001Regression, Logistic
Odds Ratio (OR)54.3095% CI26.00113.38p<0.001Regression, Logistic
Secondary/registry result

Change From Baseline in Fasting Glucose

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligrams per deciliter (mg/dL)95% CI
Placebo-2.42
10 mg Tirzepatide-49.20
15 mg Tirzepatide-51.67
LSMean Mean Difference (Net)-46.7995% CI-52.67-40.91p<0.001Mixed Models Analysis
LSMean Mean Difference (Net)-49.2595% CI-55.18-43.33p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 72

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Placebo-14.5
10 mg Tirzepatide-29.6
15 mg Tirzepatide-40.3
Estimate Difference-17.695% CI-25.5-8.9p<0.001Mixed Models Analysis
Estimate Difference-30.295% CI-37.0-22.7p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c <7%

Time frame:Week 72

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c ≤6.5%

Time frame:Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c <5.7%

Time frame:Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 72

percent change from baseline, improvement

Cardiometabolic biomarkers

18 endpoints
Secondary/registry result

Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Posted result

GroupValue (mean), percent change95% CI
Placebo2.13
Pooled 10 mg and 15 mg Tirzepatide-2.58
Estimate Difference-4.6195% CI-7.11-2.03p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Posted result

GroupValue (mean), percent change95% CI
Placebo6.29
Pooled 10 mg and 15 mg Tirzepatide2.72
Estimate Difference-3.3695% CI-7.360.81p0.112Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Posted result

GroupValue (mean), percent change95% CI
Placebo1.10
Pooled 10 mg and 15 mg Tirzepatide8.19
Estimate Difference7.0295% CI4.409.71p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

VLDL, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Placebo-6.0
Pooled 10 mg and 15 mg Tirzepatide-27.9
Estimate Difference-23.395% CI-27.5-18.9p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Posted result

GroupValue (mean), percent change95% CI
Placebo-5.8
Pooled 10 mg and 15 mg Tirzepatide-28.6
Estimate Difference-24.295% CI-28.6-19.6p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Placebo2.30
Pooled Doses of 10 mg and 15 mg Tirzepatide-6.64
Estimate Difference-8.7495% CI-12.04-5.32p<0.001Mixed Models Analysis
Secondary/registry result

Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Free fatty acids, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percent change95% CI
Placebo0.03
Pooled 10 mg and 15 mg Tirzepatide-23.58
Estimate Difference-23.6195% CI-28.62-18.24p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (least_squares_mean), millimeters of mercury (mmHg)95% CI
Placebo-1.0
Pooled 10 mg and 15 mg Tirzepatide-7.2
LSMean Mean Difference (Net)-6.295% CI-8.0-4.4p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (least_squares_mean), millimeters of mercury (mmHg)95% CI
Placebo-0.2
Pooled Doses of 10 mg and 15 mg Tirzepatide-2.6
LSMean Mean Difference (Net)-2.495% CI-3.5-1.3p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

Time frame:Baseline, Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Free fatty acids, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

4 endpoints
Secondary/registry result

Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 72

SF-36 physical

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
Placebo1.6
10 mg Tirzepatide3.4
15 mg Tirzepatide3.8
LSMean Mean Difference (Net)1.895% CI0.72.9p0.001ANCOVA
LSMean Mean Difference (Net)2.395% CI1.13.4p<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, Week 72

IWQOL-Lite physical

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
Placebo7.4
10 mg Tirzepatide14.3
15 mg Tirzepatide15.2
LSMean Difference (Net)6.995% CI4.19.7p<0.001ANCOVA
LSMean Difference (Net)7.895% CI5.010.7p<0.001ANCOVA
Secondary/protocol endpoint

Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 72

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, Week 72

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/registry result

Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

Time frame:Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanograms*hour per milliliter (ng*h/mL)95% CI
10 mg Tirzepatide153000
15 mg Tirzepatide234000
Secondary/protocol endpoint

Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

Time frame:Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

AUC₀–∞

concentration, descriptive

Publications (6)

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

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.