Renal InsufficiencyPhase 1NCT07924930
A Study of Tersolisib (LY4064809) in Participants With Kidney Impairment Compared With Participants With Normal Kidney Function
A Phase 1 study testing Tersolisib in people with Renal Insufficiency and Healthy Participant, run by Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to measure how much tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated. 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 Participant
- What is being tested?
- Tersolisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 (BMI) within the range 19 to 42 kilograms per square meter (kg/m²), inclusive
- Participants assigned male at birth (AMAB) who agree to follow contraception guidance or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP)
- Participants with Normal Renal Function:
- Are healthy with normal renal function, defined as estimated glomerular filtration rate (eGFR) greater than or equal to 90 milliliters per minute (mL/min) at screening
- Participants with Renal Impairment:
- Have moderate renal impairment, defined as eGFR greater than or equal to 30 and less than 60 mL/min, or severe renal impairment, defined as eGFR less than 30 mL/min and not requiring dialysis
- Are on stable doses of prescription or over-the-counter medications for the management of chronic kidney disease
- Have acceptable blood pressure as defined by systolic blood pressure less than 160 millimeters of mercury (mmHg) and diastolic blood pressure less than 95 mmHg, as well as acceptable pulse rate, defined as no less than 50 beats per minute (bpm) and no greater than 100 bpm.
Who cannot join
- Have history of chronic liver disease, or any evidence for hepatic impairments, or
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times (x) upper limit normal (ULN) or
- total bilirubin (TBL) greater than 1.5 x ULN
- Have a current, functional renal transplant
- Have a history or presence of any of the following clinically significant conditions: metabolic, biliary, gastrointestinal, hematological, neurological diseases, active cardiovascular (CV) disease or history of myocardial infarction within 3 months of planned dose of tersolisib, or 12-lead electrocardiogram (ECG) abnormalities that are clinically significant at screening, admission or predose.
- Have a clinically significant history of multiple or severe drug hypersensitivity reactions, or drug allergies, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine.
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- Have a history of a major surgical procedure within 30 days prior to screening.
- Have been diagnosed with, or treated for, malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix.
- Have evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
- Have a current infection with Hepatitis C Virus (HCV), that is, positive for HCV Ribonucleic Acid (RNA).
- Have a current infection with Hepatitis B Virus (HBV), that is, positive test for Hepatitis B Surface Antigen (HBsAg) or polymerase chain reaction positive for HBV DNA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States2 sites
Omega Research Orlando
Altamonte Springs, Florida, 32714
Floridian Clinical Research
Miami Lakes, Florida, 33016
About this study
Official title: A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Tersolisib in Participants With Renal Impairment Compared With Participants With Normal Renal Function
The main purpose of this study is to measure how much tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated.
For each participant, the study will last about 7 weeks including a 14-night stay in the clinical research unit (CRU) and one follow-up telephone call.
- Conditions
- Renal Insufficiency, Healthy Participant
- Being tested
- Tersolisib
- Keywords
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TersolisibDrug
Also called LY4064809, STX-478
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Tersolisib Group 1 (Normal Renal Function) | Experimental | Tersolisib administered orally to participants with normal renal function Receives: Drug: Tersolisib |
| Tersolisib Group 2 (Severe Renal Impairment) | Experimental | Tersolisib administered orally to participants with severe renal impairment Receives: Drug: Tersolisib |
| Tersolisib Group 3 (Moderate Renal Impairment, Optional) | Experimental | Tersolisib administered orally to participants with moderate renal impairment Receives: Drug: Tersolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Measured: Predose on Day 1 through Day 14
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib
Measured: Predose on Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scorpion Therapeutics, a wholly owned subsidiary of 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924930
- Sponsor's protocol ID
- 27965
- Other IDs
- J6M-MC-JSGK
- Status last verified
- Nov 2026
- First submitted
- 4 Nov 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Tersolisib in Participants With Renal Impairment Compared With Participants With Normal Renal Function
- ClinicalTrials.gov ID
- NCT07924930
- Acronym / sponsor ID
- 27965
- Conditions
- Renal Insufficiency, Healthy Participant
- Keywords
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Nov 2026 (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 tersolisib gets into the bloodstream and how long it takes the body to eliminate it in participants with kidney impairment compared to those with normal kidney function. The safety of tersolisib will also be evaluated.
For each participant, the study will last about 7 weeks including a 14-night stay in the clinical research unit (CRU) and one follow-up telephone call.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tersolisib Group 1 (Normal Renal Function) | Experimental | Drug: TersolisibTersolisib administered orally to participants with normal renal function |
| Tersolisib Group 2 (Severe Renal Impairment) | Experimental | Drug: TersolisibTersolisib administered orally to participants with severe renal impairment |
| Tersolisib Group 3 (Moderate Renal Impairment, Optional) | Experimental | Drug: TersolisibTersolisib administered orally to participants with moderate renal impairment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a body mass index (BMI) within the range 19 to 42 kilograms per square meter (kg/m²), inclusive
- Participants assigned male at birth (AMAB) who agree to follow contraception guidance or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP)
- Are healthy with normal renal function, defined as estimated glomerular filtration rate (eGFR) greater than or equal to 90 milliliters per minute (mL/min) at screening
- Have moderate renal impairment, defined as eGFR greater than or equal to 30 and less than 60 mL/min, or severe renal impairment, defined as eGFR less than 30 mL/min and not requiring dialysis
- Are on stable doses of prescription or over-the-counter medications for the management of chronic kidney disease
Key exclusion criteria (11 listed)
- Have history of chronic liver disease, or any evidence for hepatic impairments, or
- Have a current, functional renal transplant
- Have a history or presence of any of the following clinically significant conditions: metabolic, biliary, gastrointestinal, hematological, neurological diseases, active cardiovascular (CV) disease or history of myocardial infarction within 3 months of planned dose of tersolisib, or 12-lead electrocardiogram (ECG) abnormalities that are clinically significant at screening, admission or predose.
- Have a clinically significant history of multiple or severe drug hypersensitivity reactions, or drug allergies, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine.
- Have a history of a major surgical procedure within 30 days prior to screening.
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 |
|---|---|---|
| TersolisibAlso: LY4064809, STX-478Administered orally | Drug | Tersolisib Group 1 (Normal Renal Function), Tersolisib Group 2 (Severe Renal Impairment), Tersolisib Group 3 (Moderate Renal Impairment, Optional) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Time frame: Predose on Day 1 through Day 14
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib
Time frame: Predose on Day 1 through Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 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 Tersolisib in people with Renal Insufficiency and Healthy Participant, run by Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company at 2 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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib (time frame: Predose on Day 1 through Day 14). 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 9 Nov 2026.