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

NCT05556512
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
15,374
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Lead sponsor
Eli Lilly and Company
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Start date
2022-10-11
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Number of sites
671
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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.
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Acronym
SURMOUNT-MMO
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Short title
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-10-01
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First posted
2022-09-27
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Registry last updated
2026-01-12
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Primary completion date
2027-10-01
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Start date
2022-10-11
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Actual participants
15,374
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Participants
15,374
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
671
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05556512
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ClinicalTrials.gov ID
NCT05556512
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • I8F-MC-GPIJ
  • 2022-501744-15-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)