Active not recruiting

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

I8F-MC-GPGK - ClinicalTrials.gov - NCT03954834

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
How long will I be in the trial?
The study will last approximately 47 weeks and may include about 15 visits.
Email
Active not recruiting

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

I8F-MC-GPGK - ClinicalTrials.gov - NCT03954834

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
How long will I be in the trial?
The study will last approximately 47 weeks and may include about 15 visits.
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

Participant must have type 2 diabetes

Participant must be naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAM) during the 2 months preceding screening

Participant must have hemoglobin A1c ≥7.0% and ≤9.5%

Participant must be of stable weight

Participant must have a BMI ≥23 kilograms per meter squared (kg/m2)

Participants must NOT

Participant must not have type 1 diabetes

Participant must not have pancreatitis

Participant must not have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months

Participant must not have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2

Participant must not have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

472

Trial Dates

June 2019 - November 2020

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

Participant must have type 2 diabetes

Participant must be naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAM) during the 2 months preceding screening

Participant must have hemoglobin A1c ≥7.0% and ≤9.5%

Participant must be of stable weight

Participant must have a BMI ≥23 kilograms per meter squared (kg/m2)

Participants must NOT

Participant must not have type 1 diabetes

Participant must not have pancreatitis

Participant must not have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months

Participant must not have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2

Participant must not have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

Tirzepatide, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

472

Trial Dates

June 2019 - November 2020

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?