A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

J2R-MC-YAAB -

The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it.

Trial Summary

Age Range
21 - 70 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
LY3537021
Could I receive a Placebo?
Yes
Enrollment Goal
85
Trial Dates
Nov 23, 2020 - Nov 30, 2021
How long will I be in the trial?
Your participation could last about 19 weeks and may include up to 9 visits to the study center.
Trial Phase
I

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:

  • Participants must have type 2 diabetes mellitus (T2DM) diagnosed for at least 6 months

  • For part A, at screening participants must have a hemoglobin A1c value of 6.5% to 11% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

  • For part B, at screening participants must have hemoglobin A1c value 6.5% to 10% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening with or without 1 other oral antihyperglycemic medicines like DPP-IV inhibitors, SGLT-2 inhibitors, or sulfonylureas

  • Participants must be males and females not of childbearing potential

Participants Must Not:

  • Participants must not have had any major cardiovascular events like heart attack, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted) and transient ischemic attack in the last 6 months prior to screening

  • Participants must not have decompensated congestive heart failure or New York Heart Association (NYHA) classification III or IV guideline heart failure for at least 6 months prior to screening

  • Participants must not be taking diabetes medications like GLP-1 receptor agonists or insulin within the past 3 months

  • Participants must not have had an episode of very low blood glucose level within the past 3 months

  • Participants must not have known liver disease or undergone any form of bariatric surgery

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