AGA2118 Dose Regimen 3 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.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Summary

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.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)

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