LAE102 for Postmenopausal Women

(LAE102 Trial)

Overseen By Juan LIU, PHD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Laekna Limited

Must not be taking: FSH affecting, OTC, herbal

Disqualifiers: Malignancy, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and metabolism of a new treatment called LAE102, specifically for healthy postmenopausal women. Participants will receive either LAE102 or a placebo through methods such as injection or IV. The study aims to ensure that LAE102 is safe and well-tolerated before further research. Healthy postmenopausal women may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop using any over-the-counter medications and herbal medicines at least 14 days before starting the study and throughout its duration. Additionally, you cannot use any medication that may affect FSH levels in the 90 days before the study and during the study.

Is there any evidence suggesting that LAE102 is likely to be safe for humans?

Research has shown that LAE102 was safe in earlier studies. Healthy participants tolerated single doses of LAE102, administered either intravenously (IV) or subcutaneously (SC), well. These studies found no serious side effects, suggesting the treatment is generally safe. However, as this is an early-phase trial, long-term effects or rare side effects may not yet be known. Participants reported only mild side effects, if any, indicating that LAE102 could be a safe option for postmenopausal women considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LAE102 for postmenopausal women because it offers a fresh approach compared to current hormone replacement therapies. Unlike traditional treatments that primarily focus on estrogen supplementation, LAE102 targets specific pathways involved in postmenopausal symptoms, potentially offering a more tailored solution. Additionally, LAE102 comes in both IV and SC formulations, providing flexibility in administration, which could improve patient comfort and adherence. This unique approach and delivery method have the potential to address unmet needs in postmenopausal care, making it a promising candidate for further development.

What evidence suggests that LAE102 could be effective for postmenopausal women?

Research has shown that LAE102 has been promising in animal studies by preventing bone loss and reducing inflammation. These results suggest potential benefits for postmenopausal women. In earlier studies with humans, LAE102 was well tolerated, with no serious side effects. Additionally, single doses significantly increased activin A levels, indicating effective interaction with the intended body system. Overall, these findings encourage LAE102's potential effectiveness in the studied group. Participants in this trial will receive either LAE102 or a placebo, administered through different methods, to further evaluate its effects. ^{2 3 6 7 8}

Who Is on the Research Team?

Dr. Hugh Coleman, MD

Principal Investigator

Fortrea Clinical Research Unit Inc.

Are You a Good Fit for This Trial?

This trial is for healthy postmenopausal women aged 45 to 75 with a BMI of 20.0 - 32.0kg/m^2 and FSH levels ≥40 IU/L. Participants must have normal lab results, good venous access for IVs, no issues with SC injections, and be able to consent and commit to the study duration.

Inclusion Criteria

I can have blood drawn and receive IV treatments without issues.

My BMI is between 20.0 and 32.0.

My FSH hormone levels are high, above 40 IU/L.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of LAE102 or placebo via SC or IV administration

1 day

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics of LAE102

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LAE102

Trial Overview

The study tests LAE102's safety, tolerability, and how the body processes it (pharmacokinetics). It involves comparing LAE102 given intravenously (IV) or subcutaneously (SC) against placebo versions administered the same way.

How Is the Trial Designed?

Group I: LAE102 SC Experimental Treatment 1 Intervention

Participants will receive a single dose by SC administration (3 dose levels)

Group II: LAE102 IV Experimental Treatment 1 Intervention

Participants will receive a single IV dose (1 dose level)

Group III: Placebo SC Placebo Group 1 Intervention

Participants will receive a single dose by SC administration

Group IV: Placebo IV Placebo Group 1 Intervention

Participants will receive a single IV dose

Who Is Running the Clinical Trial?

Laekna Limited

Lead Sponsor

Trials

8

Recruited

610+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06908707

NCT06908707 | A Study to Investigate Safety, Tolerability ...

To evaluate the Area Under Curve (AUC) of LAE102 in healthy postmenopausal women following a single IV or SC dose, - PK: AUC of LAE102, Predose up to 8 weeks.

2.

withpower.com

withpower.com/trial/phase-1-postmenopausal-3-2025-5996a

LAE102 for Postmenopausal Women · Info for Participants

These drugs have been effective in preventing bone loss and reducing inflammation in animal studies, suggesting potential benefits for postmenopausal ...

3.

delta.larvol.com

delta.larvol.com/Products/?ProductId=5077f3d1-fb0a-4d2d-b97d-1efe08881f6a

LAE102 / Laekna Therap

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women ... A total of 64 patients were included in the study, and the ...

4.

laekna.com

laekna.com/new/435.html

Laekna Announces All Subjects Dosed in SAD Study of ...

As of today, all of the 64 subjects in total of 8 IV and SC ascending dose cohorts of the phase I single ascending dose study (the “SAD Study”) have been dosed.

5.

firstwordpharma.com

firstwordpharma.com/story/5975364

ADA 2025 - Laekna Presented Clinical and Pre- ...

Overall, LAE102 was well tolerated following a single IV or SC dose. No SAEs or TEAEs leading to discontinuation of treatment were reported. The ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06908707

NCT06908707 | A Study to Investigate Safety, Tolerability ...

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women (LAE102) · Study Overview · Contacts and Locations.

7.

laekna.com

laekna.com/new/471.html

ADA 2025 | Laekna Presented Clinical and Pre-clinical ...

Single-dose administration of LAE102 by IV or SC injection demonstrated a favorable safety profile in the healthy participants as well as ...

8.

synapse.patsnap.com

synapse.patsnap.com/drug/900ddb627c6a4b1a88d3f4ef37e15c1c

LAE-102 - Drug Targets, Indications, Patents

... Safety, Tolerability and Pharmacokinetics of LAE102 in Healthy Postmenopausal Women ... The data demonstrated an encouraging safety and tolerability profile.