A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mineral Density

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515610-41-00

Acronym

ACT23-001

Enrollment

260

Registered

2025-01-10

Start date

2025-09-11

Completion date

Unknown

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Brief summary

Percent change from Baseline to Month 12 in lumbar spine BMD

Detailed description

Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius BMD, Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius BMD, Percent change from Baseline to Months 1, 3, 6, 9, and 12 in [CCI], Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12

Interventions

DRUGPlacebo to match AGA2118

DRUGAGA2118

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from Baseline to Month 12 in lumbar spine BMD	—

Secondary

Measure	Time frame
Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius BMD, Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius BMD, Percent change from Baseline to Months 1, 3, 6, 9, and 12 in [CCI], Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12	—

Countries

Bulgaria, Denmark, Estonia, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026