A Study of LY3502970 in Participants With Type 2 Diabetes

NCT ID: NCT04426474

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3502970

LY3502970 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Placebo

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3502970

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Clinical Pharmacology of Miami

Hialeah, Florida, United States

Site Status

Hassman Research Institute

Marlton, New Jersey, United States

Site Status

Midwest Clinical Research Unit

Dayton, Ohio, United States

Site Status

Endeavor Clinical Trials

San Antonio, Texas, United States

Site Status

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, Germany

Site Status

Profil Mainz

Mainz, , Germany

Site Status

Countries

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United States Germany

Related Links

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https://trials.lillytrialguide.com/en-US/trial/7zwMq2LwDbIpQoxy04CHQ7

A Study of LY3502970 in Participants With Type 2 Diabetes

Other Identifiers

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J2A-MC-GZGC

Identifier Type: OTHER

Identifier Source: secondary_id

2020-000125-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17681

Identifier Type: -

Identifier Source: org_study_id

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