SURMOUNT-MMO

Active not recruitingPhase 3

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

671

Recruiting sites

—

Enrollment

15,374

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•Established CVD

Primary endpoint

•5-point MACE (All-cause death, Non-fatal MI, Non-fatal stroke, Coronary revascularization)

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 IDNCT05556512

Org study ID17253

Secondary ID2022-501744-15-00EU Clinical Trial Number

Secondary IDI8F-MC-GPIJEli Lilly and Company

Timeline

Milestones

Study first posted2022-09-27actual

Study start2022-10-11actual

Last update posted2026-01-12actual

Primary completion2027-10estimated (month precision)

Study completion2027-10estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²)

•Are either

–individuals ≥40 years of age with established cardiovascular disease (CVD).

–CVD is defined as meeting at least one of the following:

–Coronary artery disease

–Cerebrovascular disease

–Peripheral arterial disease OR

–individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention)

–women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or

–women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening.

Exclusion criteria

•Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma

•Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L).

•Any one of the following CV conditions within 90 days prior to screening

–MI

–acute coronary syndrome

–stroke

–coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or

–acute decompensated heart failure

•Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.

•Have a history of chronic or acute pancreatitis

•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

•Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening

•Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Endpoints (19)

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

Cardiovascular outcomes

Glycemic / diabetes

Renal / kidney

Cardiometabolic biomarkers

Weight & body composition

Heart failure

Patient-reported / QoL

Cardiovascular outcomes

10 endpoints

Primary/protocol endpoint

Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)

Time frame:Up to 5 Years

5-point MACE

time to event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Heart-failure hospitalization

Secondary/protocol endpoint

Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)

Time frame:Up to 5 Years

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/protocol endpoint

Time to the Occurrence of All-cause Death

Time frame:Up to 5 Years

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Time to First Occurrence of CV Death

Time frame:Up to 5 Years

Cardiovascular death

time to event, event

Secondary/protocol endpoint

Time to First Occurrence of MI

Time frame:Up to 5 Years

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Time to First Occurrence of Stroke

Time frame:Up to 5 Years

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Time to First Occurrence of Coronary Revascularization

Time frame:Up to 5 Years

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Time to First Occurrence of Hospitalization for Unstable Angina

Time frame:Up to 5 Years

Unstable angina hospitalization

time to event, event

Secondary/protocol endpoint

Time to first occurrence of Hospitalization or Urgent Visit

Time frame:Up to 5 Years

Atrial-fibrillation composite

time to event, event

componentsAtrial-fibrillation composite

Secondary/protocol endpoint

Time to First Occurrence of Any Component Event of Composite Endpoint (All-Cause Death, Nonfatal MI, Nonfatal Stroke, Coronary Revascularization, Heart Failure Events, > 40% Sustained Decline in eGFR, or End Stage Renal Disease)

Time frame:Up to 5 Years

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Heart-failure hospitalization, eGFR, change, End-stage renal disease

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, 156 Weeks

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes (T2D)

Time frame:Up to 5 Years

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)

Time frame:Up to 5 Years

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Heart failure

1 endpoint

Secondary/protocol endpoint

Time to First Occurrence Heart Failure (HF) Events

Time frame:Up to 5 Years

Heart-failure composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Renal / kidney

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Up to 5 Years

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)

Time frame:Up to 5 Years

Custom renal composite

time to event, event

componentseGFR, change, End-stage renal disease, Renal death

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)

Time frame:Baseline, 156 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)

Time frame:Baseline, 156 Weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, 2 Years

SF-36 physical

change from baseline, improvement

Publications (1)

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.

Canonical study publications

Tirzepatide for reduction of morbidity and mortality in adults with obesity: rationale and design of the SURMOUNT-MMO trial.
canonical
Obesity (Silver Spring, Md.)2025 Sep (month)PMID40545827doi:10.1002/oby.24332via manual canonical seed

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.