A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

  • STATUS
    Recruiting
  • End date
    Apr 17, 2023
  • participants needed
    900
  • sponsor
    Eli Lilly and Company
Updated on 26 November 2021
diabetes
glucagon
hemoglobin a1c
glucagon-like peptide-1

Summary

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Details
Condition NIDDM, Diabetes Mellitus, adiposity, Overweight, Obesity, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Placebo, Tirzepatide
Clinical Study IdentifierNCT04657003
SponsorEli Lilly and Company
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have Type 2 Diabetes (T2DM) with HbA1c 7% to 10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
Have a BMI of 27 kg/m
Are overweight or have obesity
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria

Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
Have self-reported change in body weight >5kg within 3 months prior to screening
Have had a history of chronic or acute pancreatitis
Change in body weight greater than 5 kg within 3 months prior to starting study
Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Any lifetime history of a suicide attempt
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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