LAE102 for Postmenopausal Women

(LAE102 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.

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.

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.¹²³⁴⁵

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.

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.²³⁶⁷⁸