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LAE102

Phase 1

Postmenopausal | Small molecule | Other |Eli Lilly and Company|Last Updated: Nov 17, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

LAE102 · 1 trial · 2 indications

Phase 1 1
NCT06908707A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal WomenPostmenopausal
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women
PostmenopausalUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability (number of participants with serious adverse events (SAE)) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Baseline up to 8 weeks

Number of participants with SAEs \- Evaluation of Safety and Tolerability of LAE102

To evaluate the safety and tolerability (number of participants with treatment emergent adverse events (TEAE)) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Baseline up to 8 weeks

Number of participants with TEAEs \- Evaluation of Safety and Tolerability of LAE102

Secondary Endpoints

To evaluate the Maximum Concentration (Cmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Predose up to 8 weeks
To evaluate the Area Under Curve (AUC) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Predose up to 8 weeks
To evaluate the Time of Maximum Serum Concentration (Tmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Predose up to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LAE102 SCEXPERIMENTALParticipants will receive a single dose by SC administration (3 dose levels)
Placebo SCPLACEBO_COMPARATORParticipants will receive a single dose by SC administration
LAE102 IVEXPERIMENTALParticipants will receive a single IV dose (1 dose level)
Placebo IVPLACEBO_COMPARATORParticipants will receive a single IV dose

Interventions

NameTypeDescription
LAE102 SCDRUGA single dose of LAE102 will be administered subcutaneously
Placebo SCDRUGA single dose of placebo administered subcutaneously
LAE102 IVDRUGA single dose of LAE102 administered intravenously
Placebo IVDRUGA single dose of placebo administered intravenously
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Eligibility Criteria

Age Range45 Years to 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Females aged 45 to 75 years of age inclusive, at time of signing the informed consent. * Are healthy postmenopausal female participants. * Have a body mass index (BMI) within the range 20.0 - 32.0kg/m\^2 inclusive at screening. * Have follicle stimulating hormones (FSH) levels...

Countries:United States
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Frequently asked questions about LAE102

What is LAE102 used for?

LAE102 is an investigational small molecule being studied for use in postmenopausal women. It is being evaluated in healthy adult female participants to assess its safety, tolerability, and pharmacokinetics. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes LAE102?

LAE102 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational small molecule for postmenopausal women.

What phase is LAE102 in?

LAE102 is in Phase 1 clinical development. A Phase 1 study has been completed, which investigated the safety, tolerability, and pharmacokinetics of the drug in postmenopausal women. The drug remains investigational and has not received regulatory approval.

What clinical trials is LAE102 in?

LAE102 has one completed clinical trial, identified as NCT06908707. This Phase 1 study, titled "A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women," enrolled 32 healthy female participants aged 45 years and older in the United States.

Is LAE102 FDA approved?

LAE102 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its safety and tolerability, but the drug has not yet received marketing authorization from the FDA or any other regulatory body.