AGA2118 for Osteoporosis

(ARTEMIS Trial)

Recruiting at 37 trial locations

Overseen By Deborah Lium

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Angitia Incorporated Limited

Must not be taking: Bone metabolism agents

Disqualifiers: Fractures, Vitamin D deficiency, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using any medications that affect bone metabolism. If you're taking such medications, you may need to stop them to participate.

How does the drug AGA2118 differ from other osteoporosis treatments?

AGA2118 may offer a novel approach compared to traditional osteoporosis treatments like bisphosphonates and estrogen therapy, which primarily focus on reducing bone loss. While specific details about AGA2118's mechanism or benefits are not provided, it could potentially target new pathways or offer improved efficacy or safety over existing options. ^{1 2 3 4 5}

Who Is on the Research Team?

Ricardo Dent-Acosta, MD

Principal Investigator

Angitia Incorporated Limited

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with low bone mass, which often leads to osteoporosis. Participants should not have conditions that could interfere with the study or be on treatments that affect bone metabolism.

Inclusion Criteria

BMD T-score of ≤ -2.5 to > -3.5 at the lumbar spine, total hip, or femoral neck

I am a healthy woman aged 55 to 80 and have gone through menopause.

Exclusion Criteria

My thyroid condition is not being treated.

I am taking medication that affects bone health.

Vitamin D deficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive double-blind dosing regimens of AGA2118 or placebo for 12 months

12 months

Open-label extension

Participants continue on to a 12 month open-label period, re-randomized to continue, change, or discontinue treatment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGA2118

Trial Overview The trial is testing AGA2118 against a placebo to see if it can improve bone density in the lumbar spine after one year. It's a blind test, meaning participants won't know which treatment they're getting.

How Is the Trial Designed?

Group I: AGA2118 Dose Regimen 6 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group II: AGA2118 Dose Regimen 5 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group III: AGA2118 Dose Regimen 4 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group IV: AGA2118 Dose Regimen 3 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group V: AGA2118 Dose Regimen 2 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group VI: AGA2118 Dose Regimen 1 Experimental Treatment 1 Intervention

AGA2118 selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Group VII: Placebo Regimen Placebo Group 1 Intervention

Placebo selected dose Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.

Who Is Running the Clinical Trial?

Angitia Incorporated Limited

Lead Sponsor

Trials

2

Recruited

420+

Angitia Biopharmaceuticals

Lead Sponsor

Trials

4

Recruited

900+

Published Research Related to This Trial

Over the past 25 years, new treatments for osteoporosis have significantly reduced fracture risks, with some agents lowering spine fractures by up to 70% and hip fractures by 40-50%.

Amino-bisphosphonates remain the primary treatment, while Denosumab, a new monoclonal antibody, and parathyroid hormone (the only anabolic agent) are also effective, particularly for severe cases of osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the treatment of osteoporosis. Eriksen, EF., Halse, J., Moen, MH.[2015]

Glucocorticoid treatment in female rats led to a significant decrease in bone mineral density (BMD) and deterioration of trabecular bone microarchitecture, indicating a risk for osteoporosis.

The study found that glucocorticoids may increase the expression of cannabinoid type 1 receptors (CB1R) in osteoclasts, suggesting a potential molecular mechanism contributing to glucocorticoid-induced osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of glucocorticoid on expression of cannabinoid-1 receptors in osteoclasts from tibial proximal metaphysis of rats]. Liu, SP., Chen, J., Dai, RC., et al.[2014]

Current osteoporosis treatments primarily focus on inhibiting bone resorption by osteoclasts, with established agents like bisphosphonates and SERMs reducing vertebral fractures by about 50%.

Newer agents in development, such as cathepsin K inhibitors and RANKL monoclonal antibodies, may enhance treatment efficacy, but further research is needed to determine if they can surpass the effectiveness of existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-resorptive therapies for osteoporosis. Reid, IR.[2013]

According to the new National Osteoporosis Foundation guidelines, a significant majority (72%) of U.S. white women aged 65 and older would be recommended for osteoporosis treatment based on specific criteria, including bone density measurements and fracture risk.

The Study of Osteoporotic Fractures (SOF) population showed higher femoral neck bone mineral density and was younger compared to the general U.S. population, indicating that the guidelines may lead to a high treatment recommendation rate among older women, particularly those over 75 (93%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimates of the proportion of older white women who would be recommended for pharmacologic treatment by the new U.S. National Osteoporosis Foundation Guidelines. Donaldson, MG., Cawthon, PM., Lui, LY., et al.[2022]

Current osteoporosis treatments, primarily anti-resorptive agents like bisphosphonates and estrogen therapy, have limitations in efficacy and long-term safety, highlighting the need for new therapeutic targets.

Recent research identifies promising new targets for osteoporosis treatment, focusing on the RANK-RANKL-OPG system and Wnt/β-catenin signaling pathway, which could lead to more effective anti-resorptive and anabolic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapeutic targets for osteoporosis treatment. Chen, M., Qiao, H., Su, Z., et al.[2014]

Citations

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

New developments in the treatment of osteoporosis. [2015]

2. China pubmed.ncbi.nlm.nih.gov

[The effects of glucocorticoid on expression of cannabinoid-1 receptors in osteoclasts from tibial proximal metaphysis of rats]. [2014]

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

Anti-resorptive therapies for osteoporosis. [2013]

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

Estimates of the proportion of older white women who would be recommended for pharmacologic treatment by the new U.S. National Osteoporosis Foundation Guidelines. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Emerging therapeutic targets for osteoporosis treatment. [2014]