A Study of LY3502970 in Participants With Type 2 Diabetes

Lilly logo

Lilly

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: LY3502970
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04426474
2020-000125-86 (EudraCT Number)
17681
J2A-MC-GZGC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.

Enrollment

68 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have type 2 diabetes mellitus (T2DM) for at least 6 months
  • Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
  • Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive
  • Have had a stable body weight for the 3 months prior to screening (less than [<]5% body weight change)
  • Males and females (not considered woman of childbearing potential)

Exclusion criteria

  • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
  • Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
  • Show evidence of hepatitis B, and/or positive hepatitis B surface antigen
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Any glucose-lowering medications other than metformin within 3 months prior to screening

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

68 participants in 2 patient groups, including a placebo group

LY3502970
Experimental group
Description:
LY3502970 administered orally.
Treatment:
Drug: LY3502970
Placebo
Placebo Comparator group
Description:
Placebo administered orally.
Treatment:
Drug: Placebo

Trial contacts and locations

6

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems