CClinicalTrials.gg
CompletedNCT05615467Updated Jan 18, 2023

A Study of Effect of LY3556050 on Metformin in Healthy Participants

A Phase 1 interventional study of LY3556050 and Metformin in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2022, 3 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    LY3556050 + Metformin + Iohexol

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

    Drug: LY3556050 · Drug: Metformin · Drug: Iohexol

Interventions

  • DrugLY3556050

    Administered orally.

  • DrugMetformin

    Administered orally.

  • DrugIohexol

    Administered IV.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin

    PK: AUC of Metformin

    Time frame: Predose on day 1 through 13 days postdose

  2. PK: Maximum Observed Drug Concentration (Cmax) of Metformin

    PK: Cmax of Metformin

    Time frame: Predose on day 1 through 13 days postdose

07

Study locations

1 site
  • PRA International
    Salt Lake City, Utah 84124, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05615467
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 14, 2022
Start date
Nov 15, 2022
Primary completion
Dec 27, 2022
Completion
Dec 27, 2022
Last update
Jan 18, 2023

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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