In short
AGA2115 is an investigational bispecific monoclonal antibody being studied in adults with osteogenesis imperfecta, a rare genetic condition that makes bones fragile. A Phase 2 clinical trial is currently authorised and plans to enrol 108 participants. The trial will measure whether AGA2115 can improve bone mineral density at the lumbar spine after 12 months of treatment given by subcutaneous injection.
Key points
- AGA2115 is a humanised IgG4 bispecific monoclonal antibody targeting sclerostin and dickkopf-related protein 1.
- The only registered trial is a Phase 2 study in adults with osteogenesis imperfecta caused by COL1A1 or COL1A2 genetic variations.
- The trial is currently authorised and plans to enrol 108 participants.
- AGA2115 is given by subcutaneous injection at a dose of 2000 mg.
- The main outcome is the percent change in lumbar spine bone mineral density from baseline to month 12.
What is AGA2115?
AGA2115 is an investigational substance, meaning it has not yet been approved as a medicine. Its full name describes it as a humanised IgG4 bispecific monoclonal antibody against sclerostin and dickkopf-related protein 1. A bispecific antibody is a laboratory-made protein designed to attach to two different targets at the same time. The short label AGA2115 is used for this page.
In the EU Clinical Trials Information System, the substance is recorded as a protein-based product given by subcutaneous injection. The trial record lists AGA2115 as the test substance, with a placebo used as the comparison arm.
How does AGA2115 work?
AGA2115 is designed to block two proteins: sclerostin and dickkopf-related protein 1 (DKK1). Both of these proteins normally act as brakes on bone formation. By blocking them, AGA2115 aims to allow bone-building cells to work more actively. This mechanism is being studied to see whether it can increase bone mineral density in people whose bones are unusually fragile.
Which conditions is AGA2115 being studied for?
- Osteogenesis imperfecta — a rare inherited condition in which bones break easily, often due to changes in the COL1A1 or COL1A2 genes that affect collagen, a key building block of bone.
How is AGA2115 given?
In the registered trial, AGA2115 is given as a subcutaneous injection, which means it is injected under the skin. The dose used in the trial is 2000 mg. The trial also includes a placebo arm, in which participants receive an injection that looks the same but contains no active substance.
What do the clinical trials show?
One clinical trial of AGA2115 is currently authorised in the EU registry. It is a Phase 2 study, which means it is testing the substance in a larger group of patients than in early Phase 1 studies, with a focus on how well it works and how safe it is. The trial plans to enrol 108 adults with osteogenesis imperfecta linked to COL1A1 or COL1A2 genetic variations.
The main measure in this trial is the percent change from baseline at month 12 in lumbar spine bone mineral density (BMD). Bone mineral density is a measure of how much mineral is present in bone; a higher value generally indicates stronger bone. The lumbar spine is the lower part of the back. The trial compares AGA2115 against placebo to see whether the antibody leads to a greater increase in BMD.
Who can take part in these trials?
The registered trial is for adults with osteogenesis imperfecta who have genetic variations in the COL1A1 or COL1A2 genes. The registry record does not list further details on age limits, other inclusion criteria, or exclusion criteria. The trial status is authorised, meaning it has received regulatory approval to begin, but the record does not state whether recruitment has started.
What side effects are known?
The registry record for this trial does not include information on side effects. Because AGA2115 is still investigational and only one trial is registered, no side effect profile has been published in the sources provided for this page.