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SURMOUNT-4
CompletedPhase 3Results postedA Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
70
Recruiting sites
—
Enrollment
783
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Body weight, % change
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
24 endpointsPercent Change From Randomization in Body Weight at Week 88
Time frame:Randomization (Week 36), Week 88
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | 14.8 | — |
| Tirzepatide MTD | -6.7 | — |
Percent Change From Randomization in Body Weight at Week 88
Time frame:Randomization (Week 36), Week 88
Body weight, % change
percent change from baseline, improvement
Percent Change From Randomization in Body Weight at Week 64
Time frame:Randomization (Week 36), Week 64
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | 9.9 | — |
| Tirzepatide MTD | -6.0 | — |
Change From Randomization in Body Weight
Time frame:Randomization (Week 36), Week 88
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kilogram (kg) | 95% CI |
|---|---|---|
| Placebo | 11.9 | — |
| Tirzepatide MTD | -5.7 | — |
Change From Randomization in Waist Circumference
Time frame:Randomization (Week 36), Week 88
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), centimetre (cm) | 95% CI |
|---|---|---|
| Placebo | 8.3 | — |
| Tirzepatide MTD | -4.6 | — |
Change From Randomization in Body Mass Index (BMI)
Time frame:Randomization (Week 36), Week 88
BMI, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kilogram per square metre (kg/m^2) | 95% CI |
|---|---|---|
| Placebo | 4.3 | — |
| Tirzepatide MTD | -2.1 | — |
Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period
Time frame:Week 88
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 13.50 | — |
| Tirzepatide MTD | 93.37 | — |
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline
Time frame:Baseline (Week 0) to Week 88
≥20% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo≥5% body weight reduction from baseline | 69.00 | — |
| ≥10% body weight reduction from baseline | 44.38 | — |
| ≥15% body weight reduction from baseline | 24.01 | — |
| ≥20% body weight reduction from baseline | 11.55 | — |
| Tirzepatide MTD≥5% body weight reduction from baseline | 98.49 | — |
| ≥10% body weight reduction from baseline | 93.98 | — |
| ≥15% body weight reduction from baseline | 87.05 | — |
| ≥20% body weight reduction from baseline | 72.59 | — |
≥5% body weight reduction from baseline
≥10% body weight reduction from baseline
≥15% body weight reduction from baseline
≥20% body weight reduction from baseline
Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period
Time frame:Randomization (Week 36) to Week 88
time to event, event
Posted result
| Group | Value (median), weeks | 95% CI |
|---|---|---|
| Placebo | NA | NA – NA |
| Tirzepatide MTD | NA | NA – NA |
Change From Baseline in BMI
Time frame:Baseline (Week 0), Week 88
BMI, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kg/m^2 | 95% CI |
|---|---|---|
| Placebo | -3.6 | — |
| Tirzepatide MTD | -10.0 | — |
Change From Baseline in Body Weight
Time frame:Baseline (Week 0), Week 88
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kg | 95% CI |
|---|---|---|
| Placebo | -10.0 | — |
| Tirzepatide MTD | -27.6 | — |
Percent Change From Baseline in Body Weight
Time frame:Baseline (Week 0), Week 88
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | -9.5 | — |
| Tirzepatide MTD | -26.0 | — |
Change From Baseline in Waist Circumference
Time frame:Baseline (Week 0), Week 88
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), cm | 95% CI |
|---|---|---|
| Placebo | -9.1 | — |
| Tirzepatide MTD | -22.8 | — |
Percent Change From Randomization in Body Weight at Week 64
Time frame:Randomization (Week 36), Week 64
Body weight, % change
percent change from baseline, improvement
Change From Randomization in Body Weight
Time frame:Randomization (Week 36), Week 88
Body weight, absolute change (kg)
change from baseline, improvement
Change From Randomization in Waist Circumference
Time frame:Randomization (Week 36), Week 88
Waist circumference, change
change from baseline, improvement
Change From Randomization in Body Mass Index (BMI)
Time frame:Randomization (Week 36), Week 88
BMI, change
change from baseline, improvement
Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period
Time frame:Week 88
threshold achievement, improvement
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline
Time frame:Baseline (Week 0) to Week 88
≥5% weight-loss responders
threshold achievement, improvement
Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period
Time frame:Randomization (Week 36) to Week 88
time to event, event
Change From Baseline in BMI
Time frame:Baseline (Week 0), Week 88
BMI, change
change from baseline, improvement
Change From Baseline in Body Weight
Time frame:Baseline (Week 0), Week 88
Body weight, absolute change (kg)
change from baseline, improvement
Percent Change From Baseline in Body Weight
Time frame:Baseline (Week 0), Week 88
Body weight, % change
percent change from baseline, improvement
Change From Baseline in Waist Circumference
Time frame:Baseline (Week 0), Week 88
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
12 endpointsChange From Randomization in Fasting Glucose
Time frame:Randomization (Week 36), Week 88
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 | 7.74 | — |
| Tirzepatide MTD | -0.90 | — |
Change From Randomization in Hemoglobin A1c (HbA1c)
Time frame:Randomization (Week 36), Week 88
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), percentage of HbA1c | 95% CI |
|---|---|---|
| Placebo | 0.25 | — |
| Tirzepatide MTD | -0.08 | — |
Percent Change From Randomization in Fasting Insulin
Time frame:Randomization (Week 36), Week 88
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | 23.3 | — |
| Tirzepatide MTD | -15.4 | — |
Change From Baseline in Fasting Glucose
Time frame:Baseline (Week 0), Week 88
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| Placebo | -1.72 | — |
| Tirzepatide MTD | -10.63 | — |
Change From Baseline in HbA1c
Time frame:Baseline (Week 0), Week 88
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), percentage of HbA1c | 95% CI |
|---|---|---|
| Placebo | -0.22 | — |
| Tirzepatide MTD | -0.57 | — |
Percent Change From Baseline in Fasting Insulin
Time frame:Baseline (Week 0), Week 88
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| Placebo | -29.8 | — |
| Tirzepatide MTD | -54.1 | — |
Change From Randomization in Fasting Glucose
Time frame:Randomization (Week 36), Week 88
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change From Randomization in Hemoglobin A1c (HbA1c)
Time frame:Randomization (Week 36), Week 88
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percent Change From Randomization in Fasting Insulin
Time frame:Randomization (Week 36), Week 88
percent change from baseline, improvement
Change From Baseline in Fasting Glucose
Time frame:Baseline (Week 0), Week 88
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change From Baseline in HbA1c
Time frame:Baseline (Week 0), Week 88
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percent Change From Baseline in Fasting Insulin
Time frame:Baseline (Week 0), Week 88
percent change from baseline, improvement
Cardiometabolic biomarkers
8 endpointsPercent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA))
Time frame:Randomization (Week 36), Week 88
percent change from baseline, improvement
componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, VLDL, change, Triglycerides, change, Free fatty acids, change
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| PlaceboTotal Cholesterol | 8.30 | — |
| LDL Cholesterol | 3.43 | — |
| HDL Cholesterol | 14.6 | — |
| VLDL Cholesterol | 14.7 | — |
| Triglycerides | 15.6 | — |
| FFA | -2.9 | — |
| Tirzepatide MTDTotal Cholesterol | 2.29 | — |
| LDL Cholesterol | -3.36 | — |
| HDL Cholesterol | 18.3 | — |
| VLDL Cholesterol | -7.8 | — |
| Triglycerides | -8.2 | — |
| FFA | -13.4 | — |
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
VLDL Cholesterol
Triglycerides
FFA
Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)
Time frame:Randomization (Week 36), Week 88
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Value (least_squares_mean), millimetre of mercury (mmHg) | 95% CI |
|---|---|---|
| PlaceboSBP | 8.4 | — |
| DBP | 3.2 | — |
| Tirzepatide MTDSBP | 2.1 | — |
| DBP | -0.4 | — |
SBP
DBP
Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)
Time frame:Baseline (Week 0), Week 88
percent change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percent change | 95% CI |
|---|---|---|
| PlaceboTotal Cholesterol | 2.16 | — |
| LDL Cholesterol | 2.62 | — |
| HDL Cholesterol | 9.44 | — |
| VLDL Cholesterol | -15.6 | — |
| Triglycerides | -15.3 | — |
| FFA | -9.69 | — |
| Tirzepatide MTDTotal Cholesterol | -5.01 | — |
| LDL Cholesterol | -5.21 | — |
| HDL Cholesterol | 12.29 | — |
| VLDL Cholesterol | -32.6 | — |
| Triglycerides | -33.3 | — |
| FFA | -20.38 | — |
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
VLDL Cholesterol
Triglycerides
FFA
Change From Baseline in SBP, DBP
Time frame:Baseline (Week 0), Week 88
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (least_squares_mean), mmHg | 95% CI |
|---|---|---|
| PlaceboSBP | -2.4 | — |
| DBP | -1.7 | — |
| Tirzepatide MTDSBP | -9.3 | — |
| DBP | -5.5 | — |
SBP
DBP
Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA))
Time frame:Randomization (Week 36), Week 88
percent change from baseline, improvement
Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)
Time frame:Randomization (Week 36), Week 88
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)
Time frame:Baseline (Week 0), Week 88
percent change from baseline, improvement
Change From Baseline in SBP, DBP
Time frame:Baseline (Week 0), Week 88
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Patient-reported / QoL
8 endpointsChange From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score
Time frame:Randomization (Week 36), Week 88
SF-36 physical
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), T-score | 95% CI |
|---|---|---|
| Placebo | -1.8 | — |
| Tirzepatide MTD | 0.8 | — |
Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score
Time frame:Randomization (Week 36), Week 88
IWQOL-Lite physical
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | -5.0 | — |
| Tirzepatide MTD | 4.4 | — |
Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score
Time frame:Baseline (Week 0), Week 88
SF-36 physical
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), T-score | 95% CI |
|---|---|---|
| Placebo | 3.7 | — |
| Tirzepatide MTD | 6.3 | — |
Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score
Time frame:Baseline (Week 0), Week 88
IWQOL-Lite physical
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | 16.7 | — |
| Tirzepatide MTD | 26.0 | — |
Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score
Time frame:Randomization (Week 36), Week 88
SF-36 physical
change from baseline, improvement
Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score
Time frame:Randomization (Week 36), Week 88
IWQOL-Lite physical
change from baseline, improvement
Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score
Time frame:Baseline (Week 0), Week 88
SF-36 physical
change from baseline, improvement
Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score
Time frame:Baseline (Week 0), Week 88
IWQOL-Lite physical
change from baseline, improvement
Publications (9)
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
- JAMA network open2026 Mar 2PMID41885866doi:10.1001/jamanetworkopen.2026.3274via clinicaltrials gov reference derived + pubmed nct search
- Obesity pillars2026 Mar (month)PMID41640675doi:10.1016/j.obpill.2026.100248via clinicaltrials gov reference derived + pubmed nct search
- JAMA internal medicine2026 Feb 1PMID41284285doi:10.1001/jamainternmed.2025.6112via clinicaltrials gov reference derived + pubmed nct search
- Obesity (Silver Spring, Md.)2026 Jan (month)PMID41187013doi:10.1002/oby.70067via clinicaltrials gov reference derived + pubmed nct search
- Obesity (Silver Spring, Md.)2025 Nov (month)PMID40903801doi:10.1002/oby.70011via clinicaltrials gov reference derived + pubmed nct search
- Obesity (Silver Spring, Md.)2025 Sep (month)PMID40717199doi:10.1002/oby.24348via clinicaltrials gov reference derived + pubmed nct search
- Clinical obesity2025 Jun (month)PMID39800653doi:10.1111/cob.12734via clinicaltrials gov reference derived + pubmed nct search
- JAMA2024 Jan 2PMID38078870doi:10.1001/jama.2023.24945via 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.