HealthyPhase 1NCT05914688
A Study to Compare Two Formulations of LY3209590 in Healthy Participants
A Phase 1 study testing LY3209590 (Formulation 1) and LY3209590 (Formulation 2) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3209590 (Formulation 1) and LY3209590 (Formulation 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Jun 2023to 18 Jan 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants who are overtly healthy as determined by medical evaluation
- Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
- Contraceptive use by participants should be consistent with local regulations
Who cannot join
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Have known allergies to LY3209590, related compounds, or any components of the formulation
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Are lactating or pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.
Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.
- Conditions
- Healthy
- Being tested
- LY3209590 (Formulation 1), LY3209590 (Formulation 2)
- Keywords
- Pharmacokinetics, Formulation, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3209590 (Formulation 1)Drug
Administered SC.
LY3209590 (Formulation 2)Drug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 (Formulation 1) | Experimental | Single dose of LY3209590 as formulation 1 administered subcutaneously (SC). Receives: Drug: LY3209590 (Formulation 1) |
| LY3209590 (Formulation 2) | Experimental | Single dose of LY3209590 as formulation 2 administered SC. Receives: Drug: LY3209590 (Formulation 2) |
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 from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590
PK: AUC(0-tlast) of LY3209590
Measured: Predose up to 65 days post dose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
PK: AUC(0-∞) of LY3209590
Measured: Predose up to 65 days post dose
PK: Maximum Observed Concentration (Cmax) of LY3209590
PK: Cmax of LY3209590
Measured: Predose up to 65 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start26 Jun 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 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
- NCT05914688
- Sponsor's protocol ID
- 18310
- Other IDs
- I8H-MC-BDDF
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants
- ClinicalTrials.gov ID
- NCT05914688
- Acronym / sponsor ID
- 18310
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Formulation, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 22 Jun 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 compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.
Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3209590 (Formulation 1) | Experimental | Drug: LY3209590 (Formulation 1)Single dose of LY3209590 as formulation 1 administered subcutaneously (SC). |
| LY3209590 (Formulation 2) | Experimental | Drug: LY3209590 (Formulation 2)Single dose of LY3209590 as formulation 2 administered SC. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants who are overtly healthy as determined by medical evaluation
- Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
- Contraceptive use by participants should be consistent with local regulations
Key exclusion criteria (5 listed)
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Have known allergies to LY3209590, related compounds, or any components of the formulation
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Are lactating or pregnant
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 |
|---|---|---|
| LY3209590 (Formulation 1)Administered SC. | Drug | LY3209590 (Formulation 1) |
| LY3209590 (Formulation 2)Administered SC. | Drug | LY3209590 (Formulation 2) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590
Time frame: Predose up to 65 days post dose
PK: AUC(0-tlast) of LY3209590
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
Time frame: Predose up to 65 days post dose
PK: AUC(0-∞) of LY3209590
PK: Maximum Observed Concentration (Cmax) of LY3209590
Time frame: Predose up to 65 days post dose
PK: Cmax of LY3209590
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 23 Apr 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
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 LY3209590 (Formulation 1) and LY3209590 (Formulation 2) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 5 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 23 Apr 2024. 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 Singapore. 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 from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590 (time frame: Predose up to 65 days post dose). 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 23 Apr 2024.