NCT06577935RecruitingPhase 2
A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Nov 2026
Brief summary (registry, in English)
To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in BMD at the lumbar spine in postmenopausal women with low BMD
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 11 Sept 2025
- Lead sponsor
- Angitia Inc. Ltd.
- Diseases
- Osteoporosis
- NCT number
- NCT06577935
- EU CT number
- 2024-515610-41-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 184
- 12 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis
- Positive for HIV, hepatitis C virus, or hepatitis B surface antigen
- Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer
- Myocardial infarction or stroke within the past 12 months
- Malignancy within the last 5 years
Lab values
- Known intolerance to calcium or vitamin D supplements
- Elevated transaminases
Other
- Current hypo- or hypercalcemia
- Use of agents affecting bone metabolism
- Vitamin D deficiency
- Untreated hyper- or hypothyroidism
- Current hyper- or hypoparathyroidism
- Significantly impaired renal function
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Multiprofessional Hospital For Active Treatment Plovdiv AD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Diagnostic Consultative Centre Ascendent EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| East Tallinn Central Hospital Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| Center for Clinical and Basic Research AS Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| MediTrials OÜ Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Completed |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| FutureMeds Sp. z o.o. Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.