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AGA2118 for Osteoporosis (ARTEMIS Trial)

Phase 2

Waitlist Available

Research Sponsored by Angitia Incorporated Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80

Be older than 18 years old

Must not have

Untreated hyper- or hypothyroidism

History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 9, and 12 months

Summary

This trial aims to see how well AGA2118 treatment works compared to a placebo in improving bone density in postmenopausal women with low bone mass after 12 months.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of AGA2118 are not detailed here but typically may include symptoms like nausea, headache, or hot flashes. Placebo side effects are usually psychological since it contains no active medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thyroid condition is not being treated.

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I have had fractures in my spine, wrist, upper arm, hip, or pelvis.

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My parathyroid gland is not working properly.

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My kidney function is significantly impaired.

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My calcium levels are not normal.

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I have had cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change from Baseline to Month 12 in lumbar spine bone mineral density

Secondary study objectives

Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12

Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density

Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1

+1 more

Other study objectives

Evaluation of AGA2118 observed serum concentration levels for the AGA2118 treatment groups at Week 1 post-treatment and trough levels prior to dosing

Number of participants who develop anti-AGA2118 antibodies

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: AGA2118 Dose Regimen 6Experimental Treatment1 Intervention