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SURMOUNT-2
CompletedPhase 3Results postedA 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)
Lead sponsor
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 ≥27•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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
Weight & body composition
16 endpointsPercent Change From Baseline in Body Weight
Time frame:Baseline, Week 72
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | -3.3 | — |
| 10 mg Tirzepatide | -13.4 | — |
| 15 mg Tirzepatide | -15.7 | — |
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
Time frame:Week 72
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 30.55 | — |
| 10 mg Tirzepatide | 81.55 | — |
| 15 mg Tirzepatide | 86.41 | — |
Percent Change From Baseline in Body Weight
Time frame:Baseline, Week 72
Body weight, % change
percent change from baseline, improvement
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
Time frame:Week 72
≥5% weight-loss responders
threshold achievement, improvement
Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline
Time frame:Week 72
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 8.68 | — |
| 10 mg Tirzepatide | 63.43 | — |
| 15 mg Tirzepatide | 69.58 | — |
Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline
Time frame:Week 72
≥15% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 2.57 | — |
| 10 mg Tirzepatide | 41.42 | — |
| 15 mg Tirzepatide | 51.78 | — |
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline
Time frame:Week 72
≥20% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 0.96 | — |
| 10 mg Tirzepatide | 22.98 | — |
| 15 mg Tirzepatide | 33.98 | — |
Change From Baseline in Absolute Body Weight
Time frame:Baseline, Week 72
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kilograms (kg) | 95% CI |
|---|---|---|
| Placebo | -3.2 | — |
| 10 mg Tirzepatide | -13.5 | — |
| 15 mg Tirzepatide | -15.6 | — |
Change From Baseline in Body Mass Index (BMI)
Time frame:Baseline, Week 72
BMI, change
change from baseline, improvement
Posted result
| Group | Value (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 | — |
Change From Baseline in Waist Circumference
Time frame:Baseline, Week 72
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), centimeters (cm) | 95% CI |
|---|---|---|
| Placebo | -3.4 | — |
| 10 mg Tirzepatide | -11.2 | — |
| 15 mg Tirzepatide | -13.8 | — |
Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline
Time frame:Week 72
≥10% weight-loss responders
threshold achievement, improvement
Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline
Time frame:Week 72
≥15% weight-loss responders
threshold achievement, improvement
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline
Time frame:Week 72
≥20% weight-loss responders
threshold achievement, improvement
Change From Baseline in Absolute Body Weight
Time frame:Baseline, Week 72
Body weight, absolute change (kg)
change from baseline, improvement
Change From Baseline in Body Mass Index (BMI)
Time frame:Baseline, Week 72
BMI, change
change from baseline, improvement
Change From Baseline in Waist Circumference
Time frame:Baseline, Week 72
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
12 endpointsChange From Baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline, Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), percentage of HbA1c | 95% CI |
|---|---|---|
| Placebo | -0.16 | — |
| 10 mg Tirzepatide | -2.14 | — |
| 15 mg Tirzepatide | -2.22 | — |
Percentage of Participants Who Achieve HbA1c <7%
Time frame:Week 72
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 29.31 | — |
| 10 mg Tirzepatide | 90.03 | — |
| 15 mg Tirzepatide | 90.67 | — |
Percentage of Participants Who Achieve HbA1c ≤6.5%
Time frame:Week 72
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 15.52 | — |
| 10 mg Tirzepatide | 84.05 | — |
| 15 mg Tirzepatide | 86.67 | — |
Percentage of Participants Who Achieve HbA1c <5.7%
Time frame:Week 72
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 2.76 | — |
| 10 mg Tirzepatide | 50.17 | — |
| 15 mg Tirzepatide | 55.33 | — |
Change From Baseline in Fasting Glucose
Time frame:Baseline, Week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), milligrams per deciliter (mg/dL) | 95% CI |
|---|---|---|
| Placebo | -2.42 | — |
| 10 mg Tirzepatide | -49.20 | — |
| 15 mg Tirzepatide | -51.67 | — |
Percent Change From Baseline in Fasting Insulin
Time frame:Baseline, Week 72
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | -14.5 | — |
| 10 mg Tirzepatide | -29.6 | — |
| 15 mg Tirzepatide | -40.3 | — |
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline, Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percentage of Participants Who Achieve HbA1c <7%
Time frame:Week 72
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Percentage of Participants Who Achieve HbA1c ≤6.5%
Time frame:Week 72
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Percentage of Participants Who Achieve HbA1c <5.7%
Time frame:Week 72
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Change From Baseline in Fasting Glucose
Time frame:Baseline, Week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Percent Change From Baseline in Fasting Insulin
Time frame:Baseline, Week 72
percent change from baseline, improvement
Cardiometabolic biomarkers
18 endpointsPercent 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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | 2.13 | — |
| Pooled 10 mg and 15 mg Tirzepatide | -2.58 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | 6.29 | — |
| Pooled 10 mg and 15 mg Tirzepatide | 2.72 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | 1.10 | — |
| Pooled 10 mg and 15 mg Tirzepatide | 8.19 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | -6.0 | — |
| Pooled 10 mg and 15 mg Tirzepatide | -27.9 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | -5.8 | — |
| Pooled 10 mg and 15 mg Tirzepatide | -28.6 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | 2.30 | — |
| Pooled Doses of 10 mg and 15 mg Tirzepatide | -6.64 | — |
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
| Group | Value (mean), percent change | 95% CI |
|---|---|---|
| Placebo | 0.03 | — |
| Pooled 10 mg and 15 mg Tirzepatide | -23.58 | — |
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
| Group | Value (least_squares_mean), millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Placebo | -1.0 | — |
| Pooled 10 mg and 15 mg Tirzepatide | -7.2 | — |
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
| Group | Value (least_squares_mean), millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Placebo | -0.2 | — |
| Pooled Doses of 10 mg and 15 mg Tirzepatide | -2.6 | — |
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
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
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
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
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
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
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
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
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 endpointsChange 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
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | 1.6 | — |
| 10 mg Tirzepatide | 3.4 | — |
| 15 mg Tirzepatide | 3.8 | — |
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
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | 7.4 | — |
| 10 mg Tirzepatide | 14.3 | — |
| 15 mg Tirzepatide | 15.2 | — |
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
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 endpointsPopulation 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
| Group | Value (geometric_mean), nanograms*hour per milliliter (ng*h/mL) | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 153000 | — |
| 15 mg Tirzepatide | 234000 | — |
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
- Obesity (Silver Spring, Md.)2026 Mar (month)PMID41537305doi:10.1002/oby.70122via clinicaltrials gov reference derived + pubmed nct search
- Journal of the American Society of Nephrology : JASN2025 Nov 1PMID40512543doi:10.1681/ASN.0000000764via clinicaltrials gov reference derived + pubmed nct search
- Diabetes therapy : research, treatment and education of diabetes and related disorders2025 May (month)PMID40120035doi:10.1007/s13300-025-01723-wvia clinicaltrials gov reference derived + pubmed nct search
- Lancet (London, England)2023 Aug 19PMID37385275doi:10.1016/S0140-6736(23)01200-Xvia clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.