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A Study of LY3502970 in Participants With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3502970
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Pharmacology of Miami
  • Hassman Research Institute
  • Midwest Clinical Research Unit
  • Endeavor Clinical Trials
  • Profil Institut für Stoffwechselforschung
  • Profil Mainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3502970

Placebo

Arm Description

LY3502970 administered orally.

Placebo administered orally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
PK: Area Under the Concentration Versus Time Curve of LY3502970
PK: AUC of LY3502970
Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG
PD: Change from Baseline to Week 12 in Fasting Insulin
PD: Change from Baseline to Week 12 in Fasting Insulin

Full Information

First Posted
June 8, 2020
Last Updated
July 26, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04426474
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Midwest Clinical Research Unit
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Profil Institut für Stoffwechselforschung
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
Facility Name
Profil Mainz
City
Mainz
ZIP/Postal Code
55116
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/7zwMq2LwDbIpQoxy04CHQ7
Description
A Study of LY3502970 in Participants With Type 2 Diabetes

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