A Study of LY3502970 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426474
• Other study ID #: 17681
• Secondary ID: J2A-MC-GZGC2020-
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2020
• Est. completion date: July 12, 2021

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3502970
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Germany	Profil Mainz	Mainz
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen
United States	Midwest Clinical Research Unit	Dayton	Ohio
United States	Clinical Pharmacology of Miami	Hialeah	Florida
United States	Hassman Research Institute	Marlton	New Jersey
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Follow-up (up to Day 105)
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Day 1 through Day 84: Predose up to 96 hours postdose
Secondary	PK: Area Under the Concentration Versus Time Curve of LY3502970	PK: AUC of LY3502970	Day 1 through Day 84: Predose up to 96 hours postdose
Secondary	Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)	Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG	Baseline, Week 12
Secondary	PD: Change from Baseline to Week 12 in Fasting Insulin	PD: Change from Baseline to Week 12 in Fasting Insulin	Baseline, Week 12

External Links

•   A Study of LY3502970 in Participants With Type 2 Diabetes