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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05556512
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Tirzepatide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 11, 2022
Estimated Primary Completion Date : October 7, 2027
Estimated Study Completion Date : October 7, 2027

Arm Intervention/treatment
Experimental: Tirzepatide
Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Participants will receive tirzepatide matched placebo.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  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 Outcome Measures :
  1. Time to Onset of Type 2 Diabetes (T2D) [ Time Frame: Up to 5 Years ]
  2. Hierarchical Composite of Renal Death or End-Stage Renal Disease (ESRD), Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), and eGFR Slope [ Time Frame: Estimated from Baseline (Week 0) to Study Completion Up to 5 Years ]
    Hierarchical composite of time to first occurrence of renal death or ESRD, ≥57% sustained decline in eGFR, ≥40% sustained decline in eGFR, and eGFR slope difference >0.5 milliliter/minute/1.73 square meter/year (mL/min/1.73 m²/year) will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of components.

  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. eGFR Slope [ Time Frame: Up to 5 Years ]
  15. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, 156 Weeks ]
  16. Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg) [ Time Frame: Baseline, 156 Weeks ]
  17. Change from Baseline Diastolic Blood Pressure (DBP) (mmHg) [ Time Frame: Baseline, 156 Weeks ]
  18. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05556512


Contacts
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Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 696 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05556512    
Other Study ID Numbers: 17253
I8F-MC-GPIJ ( Other Identifier: Eli Lilly and Company )
2022-500817-14-00 ( Other Identifier: EU Clinical Trial Number )
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists