SURMOUNT-1

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

118

Recruiting sites

—

Enrollment

2,539

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

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 IDNCT04184622

Org study ID17244

Secondary IDI8F-MC-GPHKEli Lilly and Company

Timeline

Milestones

Study first posted2019-12-03actual

Study start2019-12-04actual

Primary completion2022-04-01actual

Results first posted2023-04-24actual

Study completion2024-07-06actual

Last update posted2025-07-24actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, 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 (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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

20 endpoints

Primary/registry result

Percent Change From Baseline in Body Weight (Primary Treatment Period)

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	-2.4	—
5 mg Tirzepatide	-16.0	—
10 mg Tirzepatide	-21.4	—
15 mg Tirzepatide	-22.5	—

Least Square (LS) Mean Difference (Net)-13.595% CI-14.6 – -12.5p<0.001Mixed Models Analysis

LS Mean Difference (Net)-18.995% CI-20.0 – -17.8p<0.001Mixed Models Analysis

LS Mean Difference (Net)-20.195% CI-21.2 – -19.0p<0.001Mixed Models Analysis

Primary/registry result

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	27.87	—
5 mg Tirzepatide	89.41	—
10 mg Tirzepatide	96.18	—
15 mg Tirzepatide	96.32	—

Odds Ratio (OR)23.9995% CI17.43 – 33.02p<0.001Regression, Logistic

Odds Ratio (OR)73.6395% CI46.98 – 115.39p<0.001Regression, Logistic

Odds Ratio (OR)75.4895% CI47.86 – 119.03p<0.001Regression, Logistic

Primary/protocol endpoint

Percent Change From Baseline in Body Weight (Primary Treatment Period)

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 (Primary Treatment Period)

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms	95% CI
Placebo	-2.5	—
Pooled 10 mg/15 mg Tirzepatide	-13.2	—

LS Mean Difference (Net)-10.795% CI-11.2 – -10.1p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	13.54	—
5 mg Tirzepatide	73.35	—
10 mg Tirzepatide	85.85	—
15 mg Tirzepatide	90.08	—

Odds Ratio (OR)19.0395% CI14.15 – 25.60p<0.001Regression, Logistic

Odds Ratio (OR)44.1795% CI31.75 – 61.45p<.001Regression, Logistic

Odds Ratio (OR)65.6495% CI45.94 – 93.77p<.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	5.98	—
5 mg Tirzepatide	50.24	—
10 mg Tirzepatide	73.61	—
15 mg Tirzepatide	78.24	—

Odds Ratio (OR)17.0895% CI11.83 – 24.66p<0.001Regression, Logistic

Odds Ratio (OR)51.8495% CI35.42 – 75.88p<0.001Regression, Logistic

Odds Ratio (OR)66.6395% CI45.23 – 98.16p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	1.26	—
5 mg Tirzepatide	31.62	—
10 mg Tirzepatide	55.48	—
15 mg Tirzepatide	62.88	—

Odds Ratio (OR)36.9395% CI18.37 – 74.22p<0.001Regression, Logistic

Odds Ratio (OR)109.4595% CI54.50 – 219.81p<0.001Regression, Logistic

Odds Ratio (OR)150.5995% CI74.85 – 302.97p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Waist Circumference (Primary Treatment Period)

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centimeters	95% CI
Placebo	-3.4	—
5 mg Tirzepatide	-14.6	—
10 mg Tirzepatide	-19.4	—
15 mg Tirzepatide	-19.9	—

LS Mean Difference (Net)-11.295% CI-12.3 – -10.0p<0.001Mixed Models Analysis

LS Mean Difference (Net)-16.095% CI-17.2 – -14.9p<0.001Mixed Models Analysis

LS Mean Difference (Net)-16.595% CI-17.7 – -15.4p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

Time frame:Baseline, Week 176

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
Placebo	-2.1	—
5 mg Tirzepatide	-15.4	—
10 mg Tirzepatide	-19.9	—
15 mg Tirzepatide	-22.9	—

LS Mean Difference (Net)-13.295% CI-15.3 – -11.1p<.0001Mixed Models Analysis

LS Mean Difference (Net)-17.795% CI-19.8 – -15.7p<.0001Mixed Models Analysis

LS Mean Difference (Net)-20.795% CI-22.8 – -18.6p<.0001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period

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	-0.9	—
5 mg Tirzepatide	-5.9	—
10 mg Tirzepatide	-8.1	—
15 mg Tirzepatide	-8.6	—

LS Mean Difference (Net)-5.195% CI-5.5 – -4.6p<0.001Mixed Models Analysis

LS Mean Difference (Net)-7.295% CI-7.7 – -6.8p<0.001Mixed Models Analysis

LS Mean Difference (Net)-7.795% CI-8.2 – -7.3p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

Time frame:Week 176

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	24.62	—
5 mg Tirzepatide	90.61	—
10 mg Tirzepatide	91.92	—
15 mg Tirzepatide	94.78	—

Odds Ratio (OR)29.7995% CI17.73 – 50.05p<.0001Regression, Logistic

Odds Ratio (OR)35.0595% CI20.63 – 59.53p<.0001Regression, Logistic

Odds Ratio (OR)55.0595% CI29.61 – 102.34p<.0001Regression, Logistic

Secondary/protocol endpoint

Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference (Primary Treatment Period)

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

Time frame:Baseline, Week 176

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

Time frame:Week 176

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

10 endpoints

Secondary/registry result

Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Placebo	-9.7	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-46.9	—

Estimate Difference-41.295% CI-44.9 – -37.3p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

Time frame:Baseline through Week 176

Time to T2DM onset

time to event, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	12.6	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	1.2	—

Hazard Ratio (HR)0.0695% CI0.03 – 0.13p<0.0001Regression, Cox

Secondary/registry result

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)

Time frame:Baseline through Week 193

Time to T2DM onset

time to event, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	13.7	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	2.4	—

Hazard Ratio (HR)0.1295% CI0.07 – 0.21p<0.0001Regression, Cox

Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period

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	-0.07	—
5 mg Tirzepatide	-0.40	—
10 mg Tirzepatide	-0.49	—
15 mg Tirzepatide	-0.51	—

LS Mean Difference (Net)-0.3395% CI-0.36 – -0.30p<0.001Mixed Models Analysis

LS Mean Difference (Net)-0.4295% CI-0.45 – -0.38p<0.001Mixed Models Analysis

LS Mean Difference (Net)-0.4495% CI-0.48 – -0.41p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Fasting Glucose (Primary Treatment Period)

Time frame:Baseline, Week 72

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	0.86	—
5 mg Tirzepatide	-7.73	—
10 mg Tirzepatide	-9.73	—
15 mg Tirzepatide	-10.55	—

LS Mean Difference (Net)-8.5995% CI-9.97 – -7.20p<0.001Mixed Models Analysis

LS Mean Difference (Net)-10.5995% CI-11.98 – -9.21p<0.001Mixed Models Analysis

LS Mean Difference (Net)-11.4295% CI-12.80 – -10.30p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

Time frame:Baseline through Week 176

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)

Time frame:Baseline through Week 193

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose (Primary Treatment Period)

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

16 endpoints

Secondary/registry result

Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

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	-6.3	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-27.6	—

Estimate Difference-22.795% CI-25.6 – -19.8p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

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	-1.11	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-5.97	—

Estimate Difference-4.9195% CI-6.40 – -3.41p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

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	0.25	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	7.92	—

Estimate Difference7.6595% CI5.85 – 9.49p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeter of mercury (mmHg)	95% CI
Placebo	-1.3	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-8.1	—

LS Mean Difference (Net)-6.895% CI-7.9 – -5.7p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

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	-0.85	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-6.86	—

Estimate Difference-6.0695% CI-8.32 – -3.75p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

VLDL, change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Placebo	-5.6	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-27.6	—

Estimate Difference-23.395% CI-26.1 – -20.4p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Free fatty acids, change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Placebo	6.1	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-5.9	—

Estimate Difference-11.395% CI-16.1 – -6.2p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Placebo	-1.0	—
Pooled 5 mg/10 mg/15 mg Tirzepatide	-5.3	—

LS Mean Difference (Net)-4.295% CI-5.0 – -3.5p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

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 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Time frame:Baseline, Week 72

Free fatty acids, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

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 Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

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	1.7	—
Pooled 10 mg/15 mg Tirzepatide	4.0	—

LS Mean Difference (Net)2.395% CI1.6 – 2.9p<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 at Week 72 (Primary Treatment Period)

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	10.1	—
5 mg Tirzepatide	17.8	—
10 mg Tirzepatide	20.7	—
15 mg Tirzepatide	21.8	—

LS Mean Difference (Net)7.795% CI5.6 – 9.8p<0.001ANCOVA

LS Mean Difference (Net)10.795% CI8.6 – 12.8p<0.001ANCOVA

LS Mean Difference (Net)11.795% CI9.6 – 13.8p<0.001ANCOVA

Secondary/protocol endpoint

Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

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 at Week 72 (Primary Treatment Period)

Time frame:Baseline, Week 72

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)

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

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramshours per milliliter (ngh/mL)	95% CI
5 mg Tirzepatide	88900	—
10 mg Tirzepatide	177000	—
15 mg Tirzepatide	266000	—

Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)

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

AUC₀–∞

concentration, descriptive

Publications (18)

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
Efficacy and Safety of Tirzepatide in Japanese Participants With Obesity: A Subpopulation Analysis of the SURMOUNT-1 Trial.
Obesity (Silver Spring, Md.)2026 Mar (month)PMID41612966doi:10.1002/oby.70131via 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 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
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
Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes.
Journal of the American Society of Nephrology : JASN2025 Nov 1PMID40512543doi:10.1681/ASN.0000000764via 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
Weight reduction over time in tirzepatide-treated participants by early weight loss response: Post hoc analysis in SURMOUNT-1.
Diabetes, obesity & metabolism2025 Sep (month)PMID40677091doi:10.1111/dom.16554via clinicaltrials gov reference derived + pubmed nct search
Improvements in Cardiometabolic Risk Factors by Weight Reduction: A Post Hoc Analysis of Adults With Obesity Randomly Assigned to Tirzepatide.
Annals of internal medicine2025 Aug (month)PMID40550133doi:10.7326/ANNALS-24-02623via clinicaltrials gov reference derived + pubmed nct search
Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials.
Clinical obesity2025 Jun (month)PMID39800653doi:10.1111/cob.12734via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide for Obesity Treatment and Diabetes Prevention.
The New England journal of medicine2025 Mar 6PMID39536238doi:10.1056/NEJMoa2410819via clinicaltrials gov reference derived + pubmed nct search
Association between weight reduction achieved with tirzepatide and quality of life in adults with obesity: Results from the SURMOUNT-1 study.
Diabetes, obesity & metabolism2025 Feb (month)PMID39497468doi:10.1111/dom.16046via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial.
Heart (British Cardiac Society)2024 Sep 16PMID39084707doi:10.1136/heartjnl-2024-324170via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide reduces the predicted risk of developing type 2 diabetes in people with obesity or overweight: Post hoc analysis of the SURMOUNT-1 trial.
Diabetes, obesity & metabolism2023 Dec (month)PMID37700443doi:10.1111/dom.15269via 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
Tirzepatide-Friend or Foe in Diabetic Cancer Patients?
Biomolecules2022 Oct 28PMID36358930doi:10.3390/biom12111580via pubmed nct search
Tirzepatide Once Weekly for the Treatment of Obesity.
The New England journal of medicine2022 Jul 21PMID35658024doi:10.1056/NEJMoa2206038via clinicaltrials gov reference derived + 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.