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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURMOUNT-3

NCTNCT04657016 (opens ClinicalTrials.gov in a new tab)Other id17246Other idI8F-MC-GPHM
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
579 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
4 countries

United States, Argentina, Brazil, Puerto Rico

Start
29 Mar 2021
Primary completion
20 Apr 2023
Completion
12 May 2023
First posted
7 Dec 2020
Last update posted
16 May 2024
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    SURMOUNT-3

    NCT04657016

    29 Mar 2021 to 12 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Interventions

  • TirzepatideDrug
  • PlaceboOther

Arms2

  • Experimental

    Tirzepatide

    Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

  • Placebo comparator

    Placebo

    Participants received matching placebo SC once weekly (QW).

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Body Weight

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Week 72

    Registry description

    Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.

Secondary outcomes(20)

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

    Time frame · 72 Weeks

    Registry description

    Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  2. Percentage of Participants Who Achieve ≥10%Body Weight Reduction

    Time frame · 72 Weeks

    Registry description

    Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame · 72 Weeks

    Registry description

    Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  4. Percentage of Participants Who Achieve ≥20% Body Weight Reduction

    Time frame · 72 Weeks

    Registry description

    Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  5. Change From Baseline in Waist Circumference

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  6. Change From Baseline in Body Weight

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

  7. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

  8. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  9. Change From Baseline in Diastolic Blood Pressure (DBP)

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  10. Percent Change From Baseline in Total Cholesterol

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  14. Percent Change From Baseline in Triglycerides

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  15. Percent Change From Baseline in Free Fatty Acids

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  16. Change From Baseline in Fasting Glucose

    Time frame · Baseline, 72 Weeks

    Registry description

    Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  17. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, 72 Weeks

    Registry description

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  18. Percent Change From Baseline in Fasting Insulin

    Time frame · Baseline, 72 Weeks

    Registry description

    Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

  19. 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

    Registry description

    The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

  20. 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

    Registry description

    The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life. LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 72 Weeks

Percent Change From Baseline in Body Weight

GroupValue (Percent change)Spread
Placebo3.30.60
Tirzepatide-21.10.59
Primary outcomeNumber· Week 72

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

GroupValue (percentage of participants)
Placebo10.65
Tirzepatide94.37
Secondary and other outcome results(6)
Secondary outcomeNumber· 72 Weeks

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

GroupValue (percentage of participants)
Placebo37.80
Tirzepatide98.59
Secondary outcomeNumber· 72 Weeks

Percentage of Participants Who Achieve ≥10%Body Weight Reduction

GroupValue (percentage of participants)
Placebo4.81
Tirzepatide88.03
Secondary outcomeNumber· 72 Weeks

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

GroupValue (Percentage of participants)
Placebo2.06
Tirzepatide73.94
Secondary outcomeNumber· 72 Weeks

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

GroupValue (Percentage of participants)
Placebo1.03
Tirzepatide54.93
Secondary outcomeLeast squares mean· Baseline, 72 Weeks

Change From Baseline in Waist Circumference

GroupValue (Centimeters (Cms))Spread
Placebo1.10.58
Tirzepatide-16.80.56
Secondary outcomeLeast squares mean· Baseline, 72 Weeks

Change From Baseline in Body Weight

GroupValue (kg)Spread
Placebo3.50.67
Tirzepatide-21.50.65

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received matching placebo SC once weekly QW.1 / 29214 / 292172 / 292
TirzepatideParticipants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.1 / 28717 / 287230 / 287

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2026

6 results

People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment.

Li et al. 2026Obesity (Silver Spring, Md.)cited by 2

PMID 41187013PMC12724063DOI 10.1002/oby.70067PUB-41187013

CC BY6 results
Download PDFSee results (6)

Indexing hint: Randomized controlled trial · 2026

5 results

Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT.

Wadden et al. 2026Obesity (Silver Spring, Md.)cited by 3

PMID 41537305PMC12933222DOI 10.1002/oby.70122PUB-41537305

CC BY5 results
Download PDFSee results (5)

Indexing hint: Meta-analysis (pooled) · 2026

3 results

Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials.

Galindo et al. 2026JAMA network open

PMID 41885866PMC13022736DOI 10.1001/jamanetworkopen.2026.3274PUB-41885866

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

Indexing hint: Randomized controlled trial · 2025

6 results

Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.

Gourgari et al. 2025Obesity (Silver Spring, Md.)cited by 4

PMID 40717199PMC12381612DOI 10.1002/oby.24348PUB-40717199

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

More studies

2 studies on this page

PubMed tag: none · 2026

Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials.

Almandoz et al. 2026Obesity pillarscited by 6

PMID 41640675PMC12865613DOI 10.1016/j.obpill.2026.100248PUB-41640675

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 2023

Corrected

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.

Wadden et al. 2023Nature medicinecited by 364

PMID 37840095PMC10667099DOI 10.1038/s41591-023-02597-wPUB-37840095

CC BY
Download PDFRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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