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Tersolisib

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Tersolisib · 1 trial · 1 indication

Phase 1 1
NCT07662798A Study of Food Effect on Tersolisib (LY4064809) in Healthy ParticipantsHealthy
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Predose on Day 1 Through Day 28
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib
Predose on Day 1 Through Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group 1 Treatment A FastedEXPERIMENTALTersolisib administered orally.
Group 1 Treatment B High-Fat MealEXPERIMENTALTersolisib administered orally.
Group 2 Treatment A FastedEXPERIMENTALTersolisib administered orally.
Group 2 Treatment C Low-Fat MealEXPERIMENTALTersolisib administered orally.

Interventions

NameTypeDescription
TersolisibDRUGTersolisib administered orally
High-fat MealOTHERHigh-fat Meal
Low-fat MealOTHERLow-fat Meal
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations. * Normal blood pressure and pulse rate. * Body mass index (BMI) within the ...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 20, 2026NCT07662798Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT07662798Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT07662798Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 20, 2026NCT07662798Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 17, 2026NCT07662798Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 17, 2026NCT07662798Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 17, 2026NCT07662798Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07662798NEW_TRIAL: changed
LOWJun 23, 2026NCT07662798NEW_TRIAL: changed

Frequently asked questions about Tersolisib

What is Tersolisib used for?

Tersolisib is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with an active trial evaluating the effect of food on the drug in healthy volunteers. The drug is not approved for any condition and remains under investigation.

What does Tersolisib target?

Tersolisib is a small molecule that belongs to the -lisib class of drugs, which target phosphoinositide 3-kinase (PI3K). PI3K is an enzyme involved in cellular signaling pathways. The drug is being studied in healthy participants to assess its pharmacokinetic profile.

Who makes Tersolisib?

Tersolisib is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants.

What phase is Tersolisib in?

Tersolisib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to study the effect of food on the drug in healthy participants.

What clinical trials is Tersolisib in?

Tersolisib is being studied in one active Phase 1 clinical trial with the identifier NCT07662798. The trial, titled 'A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants,' is enrolling 60 healthy adults in the United States. The study is not currently recruiting participants.