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NCT Number: NCT05556512

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

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)

    Time frame: 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)

    Time frame: Up to 5 Years

  2. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Up to 5 Years

  6. Time to First Occurrence of CV Death

    Time frame: Up to 5 Years

  7. Time to First Occurrence of MI

    Time frame: Up to 5 Years

  8. Time to First Occurrence of Stroke

    Time frame: Up to 5 Years

  9. Time to First Occurrence of Coronary Revascularization

    Time frame: Up to 5 Years

  10. Time to First Occurrence Heart Failure (HF) Events

    Time frame: 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

    Time frame: Up to 5 Years

  12. Time to first occurrence of Hospitalization or Urgent Visit

    Time frame: 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)

    Time frame: 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

    Time frame: Baseline, 156 Weeks

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

    Time frame: Baseline, 156 Weeks

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

    Time frame: Baseline, 156 Weeks

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

    Time frame: 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)

    Time frame: Up to 5 Years

    In participants with prediabetes

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: SURMOUNT-MMO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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