HealthyPhase 1NCT05916560
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
A Phase 1 study testing LY3437943 in people with Healthy and Hepatic Insufficiency, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic 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
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jul 2023to 2 Mar 2025
- 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
- All Participants:
- Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
- Healthy or various degrees of hepatic impairment depending on the study group
Who cannot join
- Participants with hepatic impairment:
- Have or are anticipating an organ transplant within the next 6 months
- Requires needle evacuation of ascites fluid more than 2 times per month
- Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Arizona Clinical Trials - Chandler
Chandler, Arizona, 85225
Accel Research Sites- Clinical Research Unit
DeLand, Florida, 32720
Advanced Pharma Clinical Research
Miami, Florida, 33147-4040
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229
About this study
Official title: A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants
The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.
- Conditions
- Healthy, Hepatic Insufficiency
- Being tested
- LY3437943
- Keywords
- Pharmacokinetics, Hepatic Impairment
- Medical subject headings
- Hepatic 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 (Normal Hepatic Function) | Experimental | LY3437943 administered subcutaneously (SC). Receives: Drug: LY3437943 |
| LY3437943 (Severe Hepatic Impairment) | Experimental | LY3437943 administered SC. Receives: Drug: LY3437943 |
| LY3437943 (Moderate Hepatic Impairment) | Experimental | LY3437943 administered SC. Receives: Drug: LY3437943 |
| LY3437943 (Mild Hepatic Impairment) | Experimental | LY3437943 administered SC. 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 30 days postdose
PK: Maximum observed concentration (Cmax) of LY3437943
PK: Cmax of LY3437943
Measured: Predose up to 30 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start13 Jul 2023
- Primary completion2 Mar 2025
- Study completion2 Mar 2025
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
- 43 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
- NCT05916560
- Sponsor's protocol ID
- 18531
- Other IDs
- J1I-MC-GZBT
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2023
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants
- ClinicalTrials.gov ID
- NCT05916560
- Acronym / sponsor ID
- 18531
- Conditions
- Healthy, Hepatic Insufficiency
- Keywords
- Pharmacokinetics, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 2 Mar 2025 (actual)
- Study completion
- 2 Mar 2025 (actual)
- First posted
- 23 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 measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3437943 (Normal Hepatic Function) | Experimental | Drug: LY3437943LY3437943 administered subcutaneously (SC). |
| LY3437943 (Severe Hepatic Impairment) | Experimental | Drug: LY3437943LY3437943 administered SC. |
| LY3437943 (Moderate Hepatic Impairment) | Experimental | Drug: LY3437943LY3437943 administered SC. |
| LY3437943 (Mild Hepatic Impairment) | Experimental | Drug: LY3437943LY3437943 administered SC. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
- Healthy or various degrees of hepatic impairment depending on the study group
Key exclusion criteria (4 listed)
- Have or are anticipating an organ transplant within the next 6 months
- Requires needle evacuation of ascites fluid more than 2 times per month
- Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
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 (Mild Hepatic Impairment), LY3437943 (Moderate Hepatic Impairment), LY3437943 (Normal Hepatic Function), LY3437943 (Severe Hepatic 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 30 days postdose
PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943
Time frame: Predose up to 30 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 18 Apr 2025.
- 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
5 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 Hepatic Insufficiency, run by Eli Lilly and Company at 5 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 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 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 18 Apr 2025.