HealthyPhase 1NCT06003465
A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices
A Phase 1 study testing LY3437943, Test and Reference in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3437943, Test and Reference
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2023to 8 Feb 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
- Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
- Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
- Are agreeable to receiving study treatment by injections under the skin
- Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)
Who cannot join
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Smoke more than the equivalent of 10 cigarettes per day
- Is a known user of drugs of abuse
- Have known allergies to LY3437943 or related compounds
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Qps-Mra, Llc
Miami, Florida, 33143-4875
ICON
Salt Lake City, Utah, 84124
ICON Early Phase Services
San Antonio, Texas, 78209
About this study
Official title: A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.
- Conditions
- Healthy
- Being tested
- LY3437943, Test, Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3437943Drug
Administered SC
TestDevice
Used to administer LY3437943 SC
ReferenceDevice
Used to administer LY3437943 SC
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 - Test | Experimental | A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation) Receives: Drug: LY3437943; Device: Test |
| LY3437943 - Reference | Active comparator | A single dose of LY3437943 administered by SC injection via a reference device (reference formulation) Receives: Drug: LY3437943; Device: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
PK: Cmax of LY3437943
Measured: Predose up to 43 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943
PK: AUC[0-tlast] of LY3437943
Measured: Predose up to 43 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
PK: AUC(0-∞) of LY3437943
Measured: Predose up to 43 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start29 Aug 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT06003465
- Sponsor's protocol ID
- 18530
- Other IDs
- J1I-MC-GZBX
- Status last verified
- Mar 2024
- First submitted
- 16 Aug 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06003465
- Acronym / sponsor ID
- 18530
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 22 Aug 2023 (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 look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3437943 - Test | Experimental | Drug: LY3437943, Device: TestA single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation) |
| LY3437943 - Reference | Active comparator | Drug: LY3437943, Device: ReferenceA single dose of LY3437943 administered by SC injection via a reference device (reference formulation) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
- Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
- Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
- Are agreeable to receiving study treatment by injections under the skin
- Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)
Key exclusion criteria (4 listed)
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Smoke more than the equivalent of 10 cigarettes per day
- Is a known user of drugs of abuse
- Have known allergies to LY3437943 or related compounds
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 |
|---|---|---|
| LY3437943Administered SC | Drug | LY3437943 - Reference, LY3437943 - Test |
| TestUsed to administer LY3437943 SC | Device | LY3437943 - Test |
| ReferenceUsed to administer LY3437943 SC | Device | LY3437943 - Reference |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
Time frame: Predose up to 43 days postdose
PK: Cmax of LY3437943
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943
Time frame: Predose up to 43 days postdose
PK: AUC[0-tlast] of LY3437943
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Time frame: Predose up to 43 days postdose
PK: AUC(0-∞) of LY3437943
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 29 Mar 2024.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3437943, Test and Reference in people with Healthy, run by Eli Lilly and Company at 3 sites 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 5 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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): Maximum Concentration (Cmax) of LY3437943 (time frame: Predose up to 43 days postdose). The study lists 3 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 29 Mar 2024.