Renal InsufficiencyPhase 1NCT05841277
A Study of LY3819469 in Participants With Impaired and Normal Renal Function
A Phase 1 study testing LY3819469 in people with Renal Insufficiency and Healthy, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Healthy
- What is being tested?
- LY3819469
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Apr 2023to 9 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
- Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial
- Participants with Normal Renal Function:
- Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min)
- Participants with Renal Impairment:
- Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis
- ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing
Who cannot join
- Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition
- Have any abnormality in the 12-lead electrocardiogram (ECG)
- Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemia symptoms
- Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
- Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Floridian Clinical Research
Miami, Florida, 33016
Advanced Pharma CR, LLC
Miami, Florida, 33417
Omega Research Consultants
Orlando, Florida, 32808
Nucleus Networks
Saint Paul, Minnesota, 55114
About this study
Official title: Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.
- Conditions
- Renal Insufficiency, Healthy
- Being tested
- LY3819469
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3819469Drug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3819469 (Control) | Experimental | LY3819469 administered subcutaneously (SC) to participants with normal renal function Receives: Drug: LY3819469 |
| LY3819469 (Severe Renal Impairment) | Experimental | LY3819469 administered SC to participants with severe renal impairment Receives: Drug: LY3819469 |
| LY3819469 (End-Stage Renal Disease) | Experimental | LY3819469 administered SC to participants with end-stage renal disease (ESRD) Receives: Drug: LY3819469 |
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 last time point (AUC0-tlast) of LY3819469
PK: AUC0-tlast of LY3819469
Measured: Predose up to 85 days postdose
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
PK: AUC0-∞ of LY3819469
Measured: Predose up to 85 days postdose
PK: Maximum observed concentration (Cmax) of LY3819469
PK: Cmax of LY3819469
Measured: Predose up to 85 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start25 Apr 2023
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT05841277
- Sponsor's protocol ID
- 18731
- Other IDs
- J3L-MC-EZED
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2023
- Last updated
- 29 Mar 2024
- 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 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05841277
- Acronym / sponsor ID
- 18731
- Conditions
- Renal Insufficiency, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 3 May 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 assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3819469 (Control) | Experimental | Drug: LY3819469LY3819469 administered subcutaneously (SC) to participants with normal renal function |
| LY3819469 (Severe Renal Impairment) | Experimental | Drug: LY3819469LY3819469 administered SC to participants with severe renal impairment |
| LY3819469 (End-Stage Renal Disease) | Experimental | Drug: LY3819469LY3819469 administered SC to participants with end-stage renal disease (ESRD) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
- Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial
- Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min)
- Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis
- ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing
Key exclusion criteria (5 listed)
- Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition
- Have any abnormality in the 12-lead electrocardiogram (ECG)
- Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemia symptoms
- Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
- Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year
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 |
|---|---|---|
| LY3819469Administered SC. | Drug | LY3819469 (Control), LY3819469 (End-Stage Renal Disease), LY3819469 (Severe Renal Impairment) |
Primary outcome
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469
Time frame: Predose up to 85 days postdose
PK: AUC0-tlast of LY3819469
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
Time frame: Predose up to 85 days postdose
PK: AUC0-∞ of LY3819469
PK: Maximum observed concentration (Cmax) of LY3819469
Time frame: Predose up to 85 days postdose
PK: Cmax of LY3819469
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
Related trials for Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
4 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 LY3819469 in people with Renal Insufficiency and Healthy, run by Eli Lilly and Company at 4 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 7 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 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 4 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): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469 (time frame: Predose up to 85 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.