A Study of Tersolisib (LY4064809) in Participants With Kidney Impairment Compared With Participants With Normal Kidney Function

November 4, 2026 updated by: Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Omega Research Orlando
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tersolisib Group 1 (Normal Renal Function)

Tersolisib administered orally to participants with normal renal function
Drug: Tersolisib

Administered orally

Other Names:
  • LY4064809
  • STX-478
Experimental: Tersolisib Group 2 (Severe Renal Impairment)

Tersolisib administered orally to participants with severe renal impairment
Drug: Tersolisib

Administered orally

Other Names:
  • LY4064809
  • STX-478
Experimental: Tersolisib Group 3 (Moderate Renal Impairment, Optional)

Tersolisib administered orally to participants with moderate renal impairment
Drug: Tersolisib

Administered orally

Other Names:
  • LY4064809
  • STX-478

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Time Frame: Predose on Day 1 through Day 14
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
Predose on Day 1 through Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27965
  • J6M-MC-JSGK (Other Identifier: Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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