In short
DII235 is an investigational nucleic acid-based substance being developed to lower high levels of lipoprotein(a), also called Lp(a). It is given as a subcutaneous injection and has no marketing authorisation yet. One authorised Phase 2 trial is currently evaluating DII235 in 200 adults with elevated Lp(a), defined as at least 150 nmol/L, to see how well it reduces Lp(a) over time compared with placebo.
This page explains what DII235 is, how it works, which conditions it is being studied for, how it is given, what the clinical trial shows so far, and what is known about side effects.
Key points
- DII235 is an investigational nucleic acid-based substance with no marketing authorisation.
- It is being studied in one Phase 2 trial with 200 participants.
- The trial focuses on adults with elevated lipoprotein(a) of at least 150 nmol/L.
- DII235 is given by subcutaneous injection and compared with placebo.
- The main goal is the time-averaged percent change in Lp(a) from baseline between Day 60 and Day 360.
- The trial is currently authorised and not yet completed.
What is DII235?
DII235 is an investigational substance that has not received marketing authorisation. It is classified as a nucleic acid-based substance, meaning it is built from nucleic acid components rather than being a traditional small-molecule chemical drug. The product is supplied by Novartis Pharma AG. In the registry records, DII235 appears as the test substance in one clinical trial, meaning the trial is designed to investigate its effects directly.
How does DII235 work?
The registry data describe DII235 as a nucleic acid-based substance, but the specific molecular target is not stated in the available records. The trial is designed to measure whether DII235 lowers lipoprotein(a) levels, which suggests the substance is intended to interfere with Lp(a) production or removal, but the exact mechanism is not described in the data.
Which conditions is DII235 being studied for?
- Cardiovascular risk reduction in participants with elevated Lp(a) — the trial includes adults whose lipoprotein(a) level is at least 150 nmol/L, a group considered to have elevated Lp(a).
How is DII235 given?
DII235 is prepared as a solution for injection and is given by subcutaneous injection, which means it is injected under the skin. The trial also includes a placebo arm using sodium chloride solution for subcutaneous injection.
What do the clinical trials show?
One authorised Phase 2 trial is registered for DII235. The trial plans to enrol 200 participants with elevated Lp(a), defined as Lp(a) of at least 150 nmol/L. The study is interventional, meaning participants receive a specific treatment and are followed over time. Its primary outcomes are the time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180, and the time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360. These outcomes measure how much Lp(a) levels fall, on average, over the treatment period compared with the starting value. The trial is currently authorised, meaning it has received approval to begin but has not yet reported results.
What side effects are known?
The registry records do not include information about side effects of DII235. Because the trial is still in Phase 2 and no results have been published in the registry, the side effect profile of DII235 is not yet described in the available data.