HealthyPhase 1NCT05611957
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
A Phase 1 study testing LY3437943 in people with Healthy and Renal Insufficiency, 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 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 healthy participants. The study will last up to 5 weeks, excluding screening. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal Insufficiency
- What is being tested?
- LY3437943
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Nov 2022to 5 Sep 2023
- 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
- Normal Participants:
- Healthy male and female participants as determined by physical examination
- Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).
- Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.
- Participants with Renal Impairment:
Show all 10Show fewer
- Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator
- Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5%
- Are males or females with severe renal impairment as determined by a stable eGFR <30 mL/min, not requiring hemodialysis OR
- Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)
Who cannot join
- Have known allergies to LY3437943 or related compounds
- Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed
- Have any abnormality in the 12-lead electrocardiogram (ECG)
- Are women with a positive pregnancy test or women who are lactating
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
Nucleus Networks
Saint Paul, Minnesota, 55114
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants
The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.
- Conditions
- Healthy, Renal Insufficiency
- Being tested
- LY3437943
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3437943Drug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 (Control) | Experimental | LY3437943 administered subcutaneous (SC) to participants with normal renal function Receives: Drug: LY3437943 |
| LY3437943 (Severe Renal Impairment) | Experimental | LY3437943 administered SC to participants with severe renal impairment Receives: Drug: LY3437943 |
| LY3437943 (End-Stage Renal Disease) | Experimental | LY3437943 administered SC to participants with end-stage renal disease Receives: Drug: LY3437943 |
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 infinity (AUC0-∞) of LY3437943
PK: AUC0-∞ of LY3437943
Measured: Predose up to 31 days postdose
PK: Maximum observed concentration (Cmax) of LY3437943
PK: Cmax of LY3437943
Measured: Predose up to 31 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start16 Nov 2022
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT05611957
- Sponsor's protocol ID
- 18529
- Other IDs
- J1I-MC-GZBL
- Status last verified
- 15 Sep 2023
- First submitted
- 3 Nov 2022
- Last updated
- 2 Oct 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants
- ClinicalTrials.gov ID
- NCT05611957
- Acronym / sponsor ID
- 18529
- Conditions
- Healthy, Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 10 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 assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3437943 (Control) | Experimental | Drug: LY3437943LY3437943 administered subcutaneous (SC) to participants with normal renal function |
| LY3437943 (Severe Renal Impairment) | Experimental | Drug: LY3437943LY3437943 administered SC to participants with severe renal impairment |
| LY3437943 (End-Stage Renal Disease) | Experimental | Drug: LY3437943LY3437943 administered SC to participants with end-stage renal disease |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male and female participants as determined by physical examination
- Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).
- Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.
- Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator
Key exclusion criteria (4 listed)
- Have known allergies to LY3437943 or related compounds
- Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed
- Have any abnormality in the 12-lead electrocardiogram (ECG)
- Are women with a positive pregnancy test or women who are lactating
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 (Control), LY3437943 (End-Stage Renal Disease), LY3437943 (Severe Renal Impairment) |
Primary outcome
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
Time frame: Predose up to 31 days postdose
PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943
Time frame: Predose up to 31 days postdose
PK: Cmax 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 2 Oct 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
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 LY3437943 in people with Healthy and Renal Insufficiency, 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 10 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 2 Oct 2023. 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 infinity (AUC0-∞) of LY3437943 (time frame: Predose up to 31 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 2 Oct 2023.