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Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

AGA2118 for Osteoporosis
(ARTEMIS Trial)

Not currently recruiting at 51 trial locations

Overseen ByDeborah 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the treatment AGA2118, a new potential drug, works compared to a placebo for improving bone density in the lower spine of postmenopausal women. It targets those with low bone mass, a condition where bones are weaker and more prone to fractures. The trial includes several groups testing different doses of AGA2118. Suitable candidates are postmenopausal women with low bone density who have not experienced major bone fractures. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in bone health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AGA2118 was promising in earlier studies. Initial results from clinical trials indicate that AGA2118 can help increase bone strength, which is important for treating osteoporosis. These studies have examined both the safety and tolerability of AGA2118.

The trials found that AGA2118 is generally well-tolerated, with most participants experiencing no serious side effects. The treatment's effect on bone strength increased with higher doses, but no major safety issues emerged in these early studies.

This trial is in an early stage, so participants receive close monitoring to ensure the treatment's safety. While more research is needed to confirm long-term safety, the initial results suggest that AGA2118 could safely increase bone strength in postmenopausal women with low bone mass.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

AGA2118 is unique because it's a potential new way to tackle osteoporosis, a condition often treated with medications like bisphosphonates and hormone-related therapies. Unlike these traditional treatments, which primarily focus on slowing bone loss, AGA2118 might offer a novel approach by potentially promoting new bone growth. Researchers are excited about this treatment because it could effectively strengthen bones and reduce fracture risks in a way that's different from existing options. This could be a game-changer for those with osteoporosis, offering hope for more robust bone health.

What evidence suggests that this trial's treatments could be effective for osteoporosis?

Research has shown that AGA2118, which participants in this trial may receive, effectively increases bone strength in postmenopausal women. Early results suggest that higher doses of AGA2118 lead to greater improvements in bone strength. Studies have found that AGA2118 helps by both building new bone and slowing bone loss. This dual action is important for strengthening bones, especially in individuals with osteoporosis. So far, AGA2118 has demonstrated safety, making it a promising treatment option.³ ⁴ ⁵ ⁶ ⁷

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

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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?

Treatment groups

Experimental Treatment

Placebo Group

Group I: AGA2118 Dose Regimen 6Experimental Treatment1 Intervention