In short
Clinical trials are studying AGA2118 in postmenopausal women with low bone mass and osteoporosis. These studies aim to see whether AGA2118 can improve bone mineral density compared with placebo and to assess its overall effect in this patient group.
Key points
- Clinical trials of AGA2118 are studying postmenopausal women with low bone mass and postmenopausal osteoporosis. The main trial is a Phase 2 randomized study called ARTEMIS. It compares AGA2118 with placebo in 425 participants. The key outcome is the percent change in lumbar spine bone mineral density from the start of the study to Month 12. This means the study is looking at whether AGA2118 can improve bone density in the lower spine over one year.
Trials overview
The trial data show one study of AGA2118: NCT06577935, also called ARTEMIS, which is a Phase 2 randomized trial in postmenopausal women with low bone mass. It is an interventional study, which means researchers assign a treatment and then measure the results.
This study is authorised and plans to enroll 425 participants. The condition being studied is postmenopausal osteoporosis.
Study design and treatment groups
The trial compares AGA2118 with a placebo that is made to match it. A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers see whether the study drug makes a real difference.
The intervention listed for AGA2118 is a 840 mg subcutaneous injection. Subcutaneous injection means the medicine is given under the skin.
Who can participate
The study is designed for postmenopausal women with low bone mass. The trial data also describe the condition as postmenopausal osteoporosis.
No more detailed entry rules are provided in the source data, so the available information only confirms the broad target group.
What is being measured
The main outcome is the percent change from Baseline to Month 12 in lumbar spine BMD. Baseline means the start of the study, and BMD stands for bone mineral density, a measure of how dense and strong the bones are.
The lumbar spine is the lower part of the back. Measuring BMD there helps researchers see whether treatment may improve bone strength in an important area where fractures can happen.
Key points from the trial data
- Trial name: ARTEMIS, a Phase 2 randomized trial of AGA2118.
- Target group: postmenopausal women with low bone mass and postmenopausal osteoporosis.
- Comparison: AGA2118 versus placebo.
- Planned size: 425 participants.
- Main endpoint: change in lumbar spine BMD after 12 months.