HealthyPhase 1NCT04156750
A Study of LY3556050 in Healthy Participants
A Phase 1 study testing LY3556050, Iohexol and Metformin 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 learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3556050, Iohexol and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 3 Aug 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females of nonchild bearing potential, as determined by medical history
- Have safety laboratory results within normal references ranges
- Weight at least 50 kilograms (kg)
Who cannot join
- Have known allergies to LY3556050, iodine, metformin and related compounds
- Abnormal electrocardiogram (ECG) or blood pressure at screening
- Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
- Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3556050Drug
Administered orally.
PlaceboDrug
Administered orally.
IohexolDrug
Administered IV.
MetforminDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY3556050 (Part A) | Experimental | LY3556050 administered orally. Receives: Drug: LY3556050 |
| Placebo (Part A) | Placebo comparator | Placebo administered orally. Receives: Drug: Placebo |
| Iohexol (Part B) | Other | Iohexol given intravenously (IV). (Part B is optional.) Receives: Drug: Iohexol |
| Metformin (Part B) | Other | Metformin given orally. (Part B is optional.) Receives: Drug: Metformin |
| LY3556050+ Iohexol (Part B) | Experimental | Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) Receives: Drug: LY3556050; Drug: Iohexol |
| LY3556050 + Metformin (Part B) | Experimental | Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) Receives: Drug: LY3556050; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Final Follow-up (up to Week 9)]
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050
PK: Cmax of LY3556050
Measured: Baseline through Day 17
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)
PK: AUCτ of LY3556050
Measured: Baseline through Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start20 Nov 2019
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A - Parallel design. Part B - Open label design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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
- NCT04156750
- Sponsor's protocol ID
- 17612
- Other IDs
- J2P-MC-LXBA
- Status last verified
- 15 Aug 2020
- First submitted
- 6 Nov 2019
- Last updated
- 19 Aug 2020
- 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04156750
- Acronym / sponsor ID
- 17612
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 7 Nov 2019 (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 learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Part A - Parallel design. Part B - Open label design.
| Arm | Type | Receives |
|---|---|---|
| LY3556050 (Part A) | Experimental | Drug: LY3556050LY3556050 administered orally. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered orally. |
| Iohexol (Part B) | Other | Drug: IohexolIohexol given intravenously (IV). (Part B is optional.) |
| Metformin (Part B) | Other | Drug: MetforminMetformin given orally. (Part B is optional.) |
| LY3556050+ Iohexol (Part B) | Experimental | Drug: LY3556050, Drug: IohexolIohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) |
| LY3556050 + Metformin (Part B) | Experimental | Drug: LY3556050, Drug: MetforminMetformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females of nonchild bearing potential, as determined by medical history
- Have safety laboratory results within normal references ranges
- Weight at least 50 kilograms (kg)
Key exclusion criteria (4 listed)
- Have known allergies to LY3556050, iodine, metformin and related compounds
- Abnormal electrocardiogram (ECG) or blood pressure at screening
- Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
- Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared
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 (Part A), LY3556050 + Metformin (Part B), LY3556050+ Iohexol (Part B) |
| PlaceboAdministered orally. | Drug | Placebo (Part A) |
| IohexolAdministered IV. | Drug | Iohexol (Part B), LY3556050+ Iohexol (Part B) |
| MetforminAdministered orally. | Drug | LY3556050 + Metformin (Part B), Metformin (Part B) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Final Follow-up (up to Week 9)]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050
Time frame: Baseline through Day 17
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)
Time frame: Baseline through Day 17
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 19 Aug 2020.
- 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, Iohexol and Metformin 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 3 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 19 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Final Follow-up (up to Week 9)]). 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 19 Aug 2020.