A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

I8F-MC-GPHK -

The main purpose is to learn more about how tirzepatide affects body weight in participants with overweight and obesity.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Obesity
What the trial is testing?
Tirzepatide, Placebo
Could I receive a Placebo?
Yes
Enrollment Goal
2539
Trial Dates
Dec 4, 2019 - Jul 6, 2024
How long will I be in the trial?
The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Patients must have body mass Index (BMI) 30 kilograms per square meter (kg/m²), or 27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease

  • Patients must have history of at least one unsuccessful dietary effort to lose body weight

Participants Must Not:

  • Patients must not have Diabetes mellitus

  • Patients must not have change in body weight greater than 5 kg within 3 months prior to starting study

  • Patients must not have obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity

  • Patients must not have history of pancreatitis

  • Patients must not have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

  • Patients must not have history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years

  • Patients must not have any lifetime history of a suicide attempt

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