A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

  • STATUS
    Recruiting
  • End date
    Aug 17, 2022
  • participants needed
    370
  • sponsor
    Eli Lilly and Company
Updated on 26 November 2021
body mass index
type 2 diabetes mellitus
metformin

Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.

Details
Condition NIDDM, Diabetes Mellitus, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Placebo, Dulaglutide, LY3502970
Clinical Study IdentifierNCT05048719
SponsorEli Lilly and Company
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
Have a stable body weight for the 3 months prior to randomization
Have a body mass index (BMI) 23 kilogram/square meter (kg/m)
Males must agree to use highly effective methods of contraception
Women not of childbearing potential (WNOCBP) may participate in this trial
Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1

Exclusion Criteria

Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
Have acute or chronic pancreatitis
Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
Have gastric emptying abnormality or chronically take medications impacting GI motility
Have poorly controlled hypertension
Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
Have HIV, or Hepatitis B or Hepatitis C
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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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