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

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