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A Study of LY3502970 in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04426474
Collaborator
(none)
68
Enrollment
6
Locations
2
Arms
9.1
Actual Duration (Months)
11.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970
Actual Study Start Date :
Oct 8, 2020
Actual Primary Completion Date :
Jul 12, 2021
Actual Study Completion Date :
Jul 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3502970

LY3502970 administered orally.

Drug: LY3502970
Administered orally.
Placebo Comparator: Placebo

Placebo administered orally.

Drug: Placebo
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [Baseline through Follow-up (up to Day 105)]

    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

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Day 1 through Day 84: Predose up to 96 hours postdose]

    PK: Cmax of LY3502970

  2. PK: Area Under the Concentration Versus Time Curve of LY3502970 [Day 1 through Day 84: Predose up to 96 hours postdose]

    PK: AUC of LY3502970

  3. Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG) [Baseline, Week 12]

    Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG

  4. PD: Change from Baseline to Week 12 in Fasting Insulin [Baseline, Week 12]

    PD: Change from Baseline to Week 12 in Fasting Insulin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Pharmacology of Miami Hialeah Florida United States 33014
2 Hassman Research Institute Marlton New Jersey United States 08053
3 Midwest Clinical Research Unit Dayton Ohio United States 45417
4 Endeavor Clinical Trials San Antonio Texas United States 78229
5 Profil Institut für Stoffwechselforschung Neuss Nordrhein-Westfalen Germany 41460
6 Profil Mainz Mainz Germany 55116

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04426474
Other Study ID Numbers:
  • 17681
  • J2A-MC-GZGC
  • 2020-000125-86
First Posted:
Jun 11, 2020
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 27, 2021