Clinical trial NCT04426474: A Study of LY3502970 in Participants With Type 2 Diabetes
Official title: A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline through Follow-up (up to Day 105)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Day 1 through Day 84: Predose up to 96 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve of LY3502970
timeFrame: Day 1 through Day 84: Predose up to 96 hours postdose
measure: Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, Week 12
measure: PD: Change from Baseline to Week 12 in Fasting Insulin
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Dayton
country: United States
facility: Midwest Clinical Research Unit
state: Ohio
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Profil Mainz
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: