Recruiting

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

I8F-MC-GPHK - ClinicalTrials.gov - NCT04184622

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

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

I8F-MC-GPHK - ClinicalTrials.gov - NCT04184622

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

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Very Overweight

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

2400

Trial Dates

December 2019 - April 2024

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Very Overweight

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

2400

Trial Dates

December 2019 - April 2024

Trial Phase

3

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Trial Locations

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Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?