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

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Overweight
Obesity

Treatments

Drug: Placebo
Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05556512
2022-501744-15-00 (Other Identifier)
I8F-MC-GPIJ (Other Identifier)
17253

Details and patient eligibility

About

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.

Enrollment

15,374 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

15,374 participants in 2 patient groups, including a placebo group

Tirzepatide
Experimental group
Description:
Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
Treatment:
Drug: Tirzepatide
Placebo
Placebo Comparator group
Description:
Participants will receive tirzepatide matched placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

678

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Central trial contact

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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