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A Study of Effect of LY3556050 on Metformin in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3556050
Drug: Iohexol
Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05615467
J2P-MC-LXBE (Other Identifier)
18629

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

LY3556050 + Metformin + Iohexol
Experimental group
Description:
LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
Treatment:
Drug: Iohexol
Drug: Metformin
Drug: LY3556050

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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