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> Record changed: 2026-10-13

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

NCT05556512

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Participants

15,374

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Start date

2022-10-11

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

Number of sites

671

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Title and summary

**Summary**

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Acronym**

SURMOUNT-MMO

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Dates

**Completion date**

2027-10-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**First posted**

2022-09-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Registry last updated**

2026-01-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Primary completion date**

2027-10-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Start date**

2022-10-11

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Size and sites

**Actual participants**

15,374

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Participants**

15,374

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Number of sites**

671

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Identifiers

**Registry ID**

NCT05556512

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**ClinicalTrials.gov ID**

NCT05556512

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Outcomes

### Primary outcomes

1. 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)  
Timeframe: Up to 5 Years  
Time to first occurrence of any component event of composite, all-cause death, nonfatal MI, nonfatal stroke, coronary revascularization, or heart failure events that results in hospitalization or urgent visits.

### Secondary outcomes

1. Time to Onset of Type 2 Diabetes (T2D)  
Timeframe: Up to 5 Years
2. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)  
Timeframe: Up to 5 Years  
In participants with high or very high risk chronic kidney disease
3. Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)  
Timeframe: Up to 5 Years  
Time to first occurrence of any component event of MACE-3 (CV death, nonfatal MI or nonfatal stroke)
4. Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score  
Timeframe: Baseline, 2 Years  
The SF-36 v2 acute, 1-week recall version is a 36-item generic, participant-administered measure designed to assess the following 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role - Emotional, and Mental Health. Each domain is scored individually and further aggregated into 2 health component summary scores, physical component and mental component summary. Scoring of each domain and both summary scores are 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 and/or better health.
5. Time to the Occurrence of All-cause Death  
Timeframe: Up to 5 Years
6. Time to First Occurrence of CV Death  
Timeframe: Up to 5 Years
7. Time to First Occurrence of MI  
Timeframe: Up to 5 Years
8. Time to First Occurrence of Stroke  
Timeframe: Up to 5 Years
9. Time to First Occurrence of Coronary Revascularization  
Timeframe: Up to 5 Years
10. Time to First Occurrence Heart Failure (HF) Events  
Timeframe: Up to 5 Years  
Time to first occurrence heart failure (HF) events that result in hospitalization or urgent visits
11. Time to First Occurrence of Hospitalization for Unstable Angina  
Timeframe: Up to 5 Years
12. Time to first occurrence of Hospitalization or Urgent Visit  
Timeframe: Up to 5 Years  
Time to first occurrence of hospitalization or urgent visit due to atrial fibrillation, or cardioversion or ablation for atrial fibrillation
13. Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)  
Timeframe: Up to 5 Years  
Time to first occurrence of any component event of the composite endpoint ≥40% sustained decline in eGFR, ESRD, or renal death.
14. Percent Change from Baseline in Body Weight  
Timeframe: Baseline, 156 Weeks
15. Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)  
Timeframe: Baseline, 156 Weeks
16. Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)  
Timeframe: Baseline, 156 Weeks
17. Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)  
Timeframe: Up to 5 Years  
Percentage of participants with HbA1c \\<39 mmol/mol (5.7%) at each time where HbA1c is assessed for participants with a screening HbA1c ≥39 mmol/mol.
18. 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)  
Timeframe: Up to 5 Years  
In participants with prediabetes

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

40 Years

**Healthy volunteers**

No

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Sites

- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United States
- Aventiv ResearchMesa, United States
- Elite Clinical StudiesPhoenix, United States
- Pima HeartTucson, United States
- KLR Business Group, Inc. dba Arkansas Clinical ResearchLittle Rock, United States
- Smart Cures Clinical ResearchAnaheim, United States
- Kidney & Hypertension Center - Apple ValleyApple Valley, United States
- Hope Clinical Research, Inc.Canoga Park, United States
- John Muir Physician Network Research CenterConcord, United States
- Neighborhood Healthcare Institute of HealthEscondido, United States
- HB Clinical Trials - Fountain ValleyFountain Valley, United States
- Valiance Clinical ResearchHuntington Park, United States
- Scripps Whittier Diabetes InstituteLa Jolla, United States
- Velocity Clinical Research, San DiegoLa Mesa, United States
- First Valley Medical GroupLancaster, United States
- Long Beach Clinical TrialsLong Beach, United States
- Infinity Clinical Research - NorcoNorco, United States
- California Medical Research AssociatesNorthridge, United States
- Diabetes Associates Medical GroupOrange, United States
- University of California Irvine Medical CenterOrange, United States
- FOMAT Medical ResearchOxnard, United States
- Desert Oasis Healthcare Medical GroupPalm Springs, United States
- Dream Team Clinical ResearchPomona, United States
- Rancho Cucamonga Clinical ResearchRancho Cucamonga, United States
- Artemis Institute for Clinical ResearchRiverside, United States

And 646 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## References

- PubMed 41589430  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41589430/)
Related publication

- Related resource (trials.lilly.com)  
Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/362220)

### Other registry identifiers (2)

- I8F-MC-GPIJ
- 2022-501744-15-00

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05556512)

## Related records

### Drugs (1)

- [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (1)

- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition

### Targets (2)

- [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md)
- [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md)

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