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AGA2118

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.

Table of contents

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.[1] It is an interventional study, which means researchers assign a treatment and then measure the results.[1]

This study is authorised and plans to enroll 425 participants.[1] The condition being studied is postmenopausal osteoporosis.[1]

Study design and treatment groups

The trial compares AGA2118 with a placebo that is made to match it.[1] 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.[1]

The intervention listed for AGA2118 is a 840 mg subcutaneous injection.[1] Subcutaneous injection means the medicine is given under the skin.[1]

Who can participate

The study is designed for postmenopausal women with low bone mass.[1] The trial data also describe the condition as postmenopausal osteoporosis.[1]

No more detailed entry rules are provided in the source data, so the available information only confirms the broad target group.[1]

What is being measured

The main outcome is the percent change from Baseline to Month 12 in lumbar spine BMD.[1] Baseline means the start of the study, and BMD stands for bone mineral density, a measure of how dense and strong the bones are.[1]

The lumbar spine is the lower part of the back.[1] Measuring BMD there helps researchers see whether treatment may improve bone strength in an important area where fractures can happen.[1]

Key points from the trial data

  • Trial name: ARTEMIS, a Phase 2 randomized trial of AGA2118.[1]

  • Target group: postmenopausal women with low bone mass and postmenopausal osteoporosis.[1]

  • Comparison: AGA2118 versus placebo.[1]

  • Planned size: 425 participants.[1]

  • Main endpoint: change in lumbar spine BMD after 12 months.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06577935 Phase 2 Postmenopausal osteoporosis / low bone mass Authorised 425

FAQ

  • What is being studied in the AGA2118 trial? The trial is testing whether AGA2118 changes bone mineral density in postmenopausal women with low bone mass. The main comparison is AGA2118 versus placebo, which is a look-alike treatment with no active study drug.
  • Who can take part in the study? The study is for postmenopausal women with low bone mass and postmenopausal osteoporosis. The trial data do not list more detailed entry rules.
  • What phase is the AGA2118 trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to gather safety information.
  • What condition is the trial focused on? The trial focuses on postmenopausal osteoporosis and low bone mass. These terms mean bone strength is reduced, which can raise the risk of fractures.
  • What result is the study measuring? The main result is the percent change in lumbar spine bone mineral density from the start of the study to Month 12. Bone mineral density, often called BMD, is a measure of how strong and dense the bones are.

Ongoing Clinical Trials on AGA2118

  • Study on the Effects of AGA2118 for Postmenopausal Women with Osteoporosis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark Estonia Poland

Glossary

  • Postmenopausal: A stage after a woman has stopped having monthly periods. In this study, it refers to women after menopause.
  • Osteoporosis: A condition where bones become weak and more likely to break.
  • Low bone mass: Bone density that is lower than normal, but not always as severe as osteoporosis.
  • Bone mineral density (BMD): A test measure that shows how dense and strong the bones are.
  • Lumbar spine: The lower part of the back, made up of the bones in the lower spine.
  • Placebo: A look-alike treatment used in studies to compare against the study drug. It does not contain the active study drug.
  • Randomized trial: A study where participants are assigned by chance to different treatment groups.
  • Interventional study: A study where researchers give a treatment and then measure its effects.
  • Phase 2: A study stage that checks whether a treatment may work and continues to collect safety information.
  • Enrollment: The number of participants planned for the study.

References