A Study of Effect of LY3556050 on Metformin in Healthy Participants

NCT ID: NCT05615467

Last Updated: 2023-01-18

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2022-12-27

Brief Summary

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The main purpose of this study is to evaluate how much Metformin gets into the bloodstream and how long the body takes to get rid of it when it is administered orally in combination with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney function. Each enrolled participant will remain in the study for up to 7 weeks including the screening period.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3556050 + Metformin + Iohexol

LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Metformin

Intervention Type DRUG

Administered orally.

Iohexol

Intervention Type DRUG

Administered IV.

Interventions

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LY3556050

Administered orally.

Intervention Type DRUG

Metformin

Administered orally.

Intervention Type DRUG

Iohexol

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are overtly healthy as determined by medical evaluation
* Participants with body weight of at least 50 kilograms (kg) or more and have a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²)
* Have an ECG at screening considered to be within acceptable limits by the investigator
* Male participants who agree to use contraception and female participants of child bearing potential who agree to use contraception and women not of child bearing potential may participate.

Exclusion Criteria

* Women who are lactating
* Have known allergies or contraindications to LY3556050, metformin, iodine, iohexol, or other contrast agents, related compounds or any components of their formulation, or history of significant atopy
* Have a history, or ECG findings, of clinically significant bradycardia, heart block, tachycardia, sick sinus syndrome/sinoatrial block, first-degree AV block, or second- or third-degree AV block, bundle branch block or other tachy- or brady-arrhythmias; o rhave any other abnormality in the 12-lead ECG that, in the opinion of the investigator, confounds assessment of QT interval or increases the risks associated with participating in the study
* Have active or a history of gastritis or peptic ulcer disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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PRA International

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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J2P-MC-LXBE

Identifier Type: OTHER

Identifier Source: secondary_id

18629

Identifier Type: -

Identifier Source: org_study_id

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