The purpose of the study is to see whether oral semaglutide can help slow worsening of memory, thinking, and daily function in people with early Alzheimer’s disease, and to check its safety. The study is randomised, which means the treatment is assigned by chance, and double-blind, which means neither the participants nor the study team knows who receives semaglutide or placebo during the study. Treatment is taken by mouth over a long period, and the study follows changes over time.

Participants take the study tablets regularly and are seen at planned visits during the trial. These visits are used to monitor health, review how the person is doing, and record any changes in memory, daily activities, or side effects. The study compares how people do over time in the semaglutide and placebo groups.

The study is planned in two groups, and neither the participants nor the study team will know which treatment is given. After starting treatment, the medicine is taken for a period of time and then the study looks at changes in urine protein and kidney function over about 20 weeks. The study is designed to compare BI 764198 with placebo across the different kidney disease groups.

People in the study are assigned by chance to receive either inclisiran or placebo, and neither the participants nor the study team knows which one is given. The study follows participants over time while they receive the injections and are checked regularly for major heart-related problems such as myocardial infarction (heart attack), ischemic stroke (stroke caused by a blocked blood vessel), death from heart disease, or urgent procedures to open blocked heart arteries. The main purpose of the study is to find out whether inclisiran lowers the risk of these serious events better than placebo.

The study follows people who have already completed an earlier asciminib study and are considered by the doctor to still benefit from treatment. Treatment is continued over time, and regular study visits are planned so that health and any side effects can be watched. The study looks at possible adverse events, which are unwanted health problems that happen during treatment, and serious adverse events, which are more severe health problems. In some parts of the study, other tyrosine kinase inhibitors that may have been used in earlier studies include nilotinib, dasatinib, imatinib, and bosutinib.

The study is designed to provide continued access to the same study treatment received before while long-term safety is followed over time.