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

32 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug LAE102 for postmenopausal women?

Research on similar drugs, like lasofoxifene and bazedoxifene, shows they can reduce the risk of bone fractures in postmenopausal women by acting on estrogen receptors, which are important for bone health. These drugs have been effective in preventing bone loss and reducing inflammation in animal studies, suggesting potential benefits for postmenopausal osteoporosis. ^{1 2 3 4 5}

Is LAE102 safe for postmenopausal women?

The safety of LAE102, also known as bazedoxifene, has been studied in postmenopausal women with osteoporosis. In a study with 423 participants, it was generally well-tolerated, but some women experienced side effects. Common side effects included peripheral edema (swelling in the limbs) and venous thromboembolism (blood clots in veins). ^{2 4 6 7 8}

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women

Research Team

Dr. Hugh Coleman, MD

Principal Investigator

Fortrea Clinical Research Unit Inc.

Eligibility Criteria

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.

I am willing to attend all study visits and follow the study's procedures.

I am a woman aged between 45 and 75.

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. Ireland pubmed.ncbi.nlm.nih.gov

An update on selective estrogen receptor modulators for the prevention and treatment of osteoporosis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Lasofoxifene (CP-336,156), a novel selective estrogen receptor modulator, in preclinical studies. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Selective oestrogen receptor modulators lasofoxifene and bazedoxifene inhibit joint inflammation and osteoporosis in ovariectomised mice with collagen-induced arthritis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of conjugated estrogens/bazedoxifene on lipid and coagulation variables: a randomized placebo- and active-controlled trial. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

From the Women's Health Initiative to the combination of estrogen and selective estrogen receptor modulators to avoid progestin addition. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Safety and effectiveness profile of raloxifene in long-term, prospective, postmarketing surveillance. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Bazedoxifene, a selective estrogen receptor modulator: effects on the endometrium, ovaries, and breast from a randomized controlled trial in osteoporotic postmenopausal women. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis. [2022]