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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURMOUNT-2

NCTNCT04657003 (opens ClinicalTrials.gov in a new tab)Other id17245Other idI8F-MC-GPHL
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Argentina, Brazil, India, Japan, Puerto Rico, Russia, Taiwan

Start
29 Mar 2021
Primary completion
16 Mar 2023
Completion
10 Apr 2023
First posted
7 Dec 2020
Last update posted
8 Apr 2024
Conditions
Type 2 Diabetes · Overweight · Obesity

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-2

    NCT04657003

    29 Mar 2021 to 10 Apr 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 type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Interventions

  • TirzepatideDrug
  • PlaceboOther

Arms3

  • Experimental

    10 milligrams (mg) Tirzepatide

    10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)

  • Experimental

    15 mg Tirzepatide

    15 mg Tirzepatide administered SC QW

  • Placebo comparator

    Placebo

    Placebo administered SC QW

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 72

    Registry description

    Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve ≥5% body weight reduction from baseline

Secondary outcomes(20)

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

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve ≥10% body weight reduction from baseline

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

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve ≥15% body weight reduction from baseline

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

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve ≥20% body weight reduction from baseline

  4. Change From Baseline in Absolute Body Weight

    Time frame · Baseline, Week 72

    Registry description

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, Week 72

    Registry description

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  6. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 72

    Registry description

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

  7. Percentage of Participants Who Achieve HbA1c <7%

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve HbA1c \<7%

  8. Percentage of Participants Who Achieve HbA1c ≤6.5%

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve HbA1c ≤6.5%

  9. Percentage of Participants Who Achieve HbA1c <5.7%

    Time frame · Week 72

    Registry description

    Percentage of participants who achieve HbA1c \<5.7%

  10. Change From Baseline in Fasting Glucose

    Time frame · Baseline, Week 72

    Registry description

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).

  11. Change From Baseline in Waist Circumference

    Time frame · Baseline, Week 72

    Registry description

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, Week 72

    Registry description

    Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.

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

    Time frame · Baseline, Week 72

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

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

    Time frame · Baseline, Week 72

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  15. 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

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

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

    Time frame · Baseline, Week 72

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  17. 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

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

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

    Time frame · Baseline, Week 72

    Registry description

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

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

    Time frame · Baseline, Week 72

    Registry description

    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

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

    Time frame · Baseline, Week 72

    Registry description

    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).

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, Week 72

Percent Change From Baseline in Body Weight

GroupValue (percent change)Spread
Placebo-3.30.49
10 mg Tirzepatide-13.40.48
15 mg Tirzepatide-15.70.49
Primary outcomeNumber· Week 72

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

GroupValue (percentage of participants)
Placebo30.55
10 mg Tirzepatide81.55
15 mg Tirzepatide86.41
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 72

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

GroupValue (percentage of participants)
Placebo8.68
10 mg Tirzepatide63.43
15 mg Tirzepatide69.58
Secondary outcomeNumber· Week 72

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

GroupValue (percentage of participants)
Placebo2.57
10 mg Tirzepatide41.42
15 mg Tirzepatide51.78
Secondary outcomeNumber· Week 72

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

GroupValue (percentage of participants)
Placebo0.96
10 mg Tirzepatide22.98
15 mg Tirzepatide33.98
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Absolute Body Weight

GroupValue (kilograms (kg))Spread
Placebo-3.20.51
10 mg Tirzepatide-13.50.51
15 mg Tirzepatide-15.60.51
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Body Mass Index (BMI)

GroupValue (kilograms per meter squared (kg/m^2))Spread
Placebo-1.20.19
10 mg Tirzepatide-4.90.18
15 mg Tirzepatide-5.70.19
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (percentage of HbA1c)Spread
Placebo-0.160.067
10 mg Tirzepatide-2.140.060
15 mg Tirzepatide-2.220.060

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received Placebo administered SC QW.0 / 31523 / 315158 / 315
10 mg TirzepatideParticipants received 10 mg Tirzepatide administered SC QW.2 / 31218 / 312169 / 312
15 mg TirzepatideParticipants received 15 mg Tirzepatide administered SC QW.0 / 31127 / 311159 / 311

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

Studies5

Studies that cite this trial.

Studies with results

3 studies on this page

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: Randomized controlled trial · 2026

4 results

Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials.

Kokkinos et al. 2026Diabetes, obesity & metabolismcited by 2

PMID 42348366PMC13448863DOI 10.1111/dom.71009PUB-42348366

Free to read · publisher termsCC BY-NC-ND4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2023

9 results

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Garvey et al. 2023Lancet (London, England)cited by 604

PMID 37385275DOI 10.1016/s0140-6736(23)01200-xPUB-37385275

Rights unknown9 results
Source linkSee results (9)

More studies

2 studies on this page

PubMed tag: none · 2025

Tirzepatide Was Associated with Improved Health-Related Quality of Life in Adults with Obesity or Overweight and Type 2 Diabetes: Results from the Phase 3 SURMOUNT-2 Trial.

Hunter Gibble et al. 2025Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 16

PMID 40120035PMC12006608DOI 10.1007/s13300-025-01723-wPUB-40120035

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

PubMed tag: none · 2025

Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes.

Heerspink et al. 2025Journal of the American Society of Nephrology : JASNcited by 17

PMID 40512543PMC12591676DOI 10.1681/asn.0000000764PUB-40512543

CC BY
Download PDF

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 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

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