In short
LY4268989 adipic acid is an investigational substance being studied for the treatment of moderately to severely active ulcerative colitis. The available registry data describe one Phase 2 clinical trial, which plans to enroll 374 participants. The trial aims to find out whether LY4268989 can induce clinical remission after 10 weeks of treatment and help maintain remission up to Week 52.
Key points
- LY4268989 adipic acid is an investigational substance with no marketing authorisation described in the available records.
- The only registered trial is a Phase 2 study in moderately to severely active ulcerative colitis.
- The trial plans to enroll 374 participants and is currently authorised.
- The primary goal is to measure clinical remission using the Modified Mayo Score at Week 10 and Week 52.
- The study compares LY4268989 given by oral use against a placebo.
What is LY4268989 adipic acid?
LY4268989 adipic acid is an investigational substance. The available registry records do not state a marketing authorisation for this substance, which means it is still being studied in clinical research rather than being available as an approved medicine. The registry record for the single trial lists the substance under the name LY4268989 adipic acid and also mentions a related intervention called MORF+Adipic Acid. The trial is registered in the EU Clinical Trials Information System (CTIS), which indicates that the research is being conducted within the European regulatory framework.
How does LY4268989 adipic acid work?
The registry data provided do not include information about the mechanism of action of LY4268989 adipic acid. No supplementary sources describing how the substance works at a molecular level were included in the available information. What the trial record does show is that the substance is being tested against a placebo in people with ulcerative colitis, a condition in which the lining of the large intestine becomes inflamed. The primary measure of effect is clinical remission, meaning that the signs and symptoms of the disease are reduced to a level considered clinically meaningful.
Which conditions is LY4268989 adipic acid studied for?
- Moderately to severely active ulcerative colitis — a chronic inflammatory bowel disease affecting the large intestine, in which the inflammation is active enough to cause significant symptoms. The trial focuses on participants whose disease is active at a moderate or severe level.
How is LY4268989 adipic acid given?
In the registered trial, LY4268989 adipic acid is given by oral use, meaning it is taken by mouth. The registry record lists the dose as 0 mg, which indicates that the dose was not reported in the register. The pharmaceutical form is not described in the available data. The trial also includes a placebo arm, in which participants receive a substance made to match LY4268989 but containing no active ingredient.
What do the clinical trials show?
The available registry data contain one clinical trial of LY4268989 adipic acid. The study is a Phase 2 trial, which means it is an early test of whether the substance has a meaningful effect in people with the condition, while also gathering information on safety and dosing. The trial is authorised, meaning it has received the necessary approvals to begin or continue recruiting participants. The planned enrollment is 374 participants.
The trial has two main goals. First, it evaluates whether 10 weeks of treatment with LY4268989 is better than placebo at achieving clinical remission, measured with the Modified Mayo Score (mMS). The Modified Mayo Score is a tool used in ulcerative colitis research that combines measures of stool frequency, rectal bleeding, findings from endoscopy, and a physician's overall assessment. Second, among participants who respond to LY4268989 at Week 10, the trial evaluates whether continuing treatment helps maintain clinical remission at Week 52.
The trial is interventional, meaning participants receive a specific treatment according to a study plan rather than only being observed. The comparison is against a placebo, which helps researchers understand whether any improvements are due to the active substance itself.
What side effects are known?
The registry record provided does not include information about side effects of LY4268989 adipic acid. No supplementary sources describing known side effects were available. In a Phase 2 trial, collecting information about safety and side effects is one of the purposes of the research, but the results are not yet reported in the available data.