HealthyPhase 1NCT05615467
A Study of Effect of LY3556050 on Metformin in Healthy Participants
A Phase 1 study testing LY3556050, Metformin and Iohexol in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3556050, Metformin and Iohexol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 27 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study in Healthy Participants to Evaluate the Effect of LY3556050 on Metformin Pharmacokinetics
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3556050Drug
Administered orally.
MetforminDrug
Administered orally.
IohexolDrug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3556050 + Metformin + Iohexol | Experimental | LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV). Receives: Drug: LY3556050; Drug: Metformin; Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin
PK: AUC of Metformin
Measured: Predose on day 1 through 13 days postdose
PK: Maximum Observed Drug Concentration (Cmax) of Metformin
PK: Cmax of Metformin
Measured: Predose on day 1 through 13 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Nov 2022
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615467
- Sponsor's protocol ID
- 18629
- Other IDs
- J2P-MC-LXBE
- Status last verified
- Jan 2023
- First submitted
- 11 Nov 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study in Healthy Participants to Evaluate the Effect of LY3556050 on Metformin Pharmacokinetics
- ClinicalTrials.gov ID
- NCT05615467
- Acronym / sponsor ID
- 18629
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3556050 + Metformin + Iohexol | Experimental | Drug: LY3556050, Drug: Metformin, Drug: IohexolLY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3556050Administered orally. | Drug | LY3556050 + Metformin + Iohexol |
| MetforminAdministered orally. | Drug | LY3556050 + Metformin + Iohexol |
| IohexolAdministered IV. | Drug | LY3556050 + Metformin + Iohexol |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin
Time frame: Predose on day 1 through 13 days postdose
PK: AUC of Metformin
PK: Maximum Observed Drug Concentration (Cmax) of Metformin
Time frame: Predose on day 1 through 13 days postdose
PK: Cmax of Metformin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3556050, Metformin and Iohexol in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin (time frame: Predose on day 1 through 13 days postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.