In short
Clinical trials are investigating KAI-9531 for people living with obesity, with or without diabetes. These studies aim to compare KAI-9531 with semaglutide or placebo and measure weight loss, blood sugar change, and safety in adults.
Key points
- Clinical trials are studying KAI-9531 in adults with obesity, and in one trial, adults with obesity or overweight and diabetes. All three studies are Phase 3 and are currently authorised. The main goal is to measure how much body weight changes by Week 76, and one study also checks hemoglobin A1c, a blood sugar marker. One trial compares KAI-9531 with semaglutide and placebo, while the other studies compare it with placebo. Planned enrollment is large, ranging from 1,200 to 1,800 participants.
Overview of the trials
These clinical trials are studying KAI-9531 in people living with obesity, and in one study, people with obesity or overweight and diabetes.
The studies are designed to look at efficacy (how well a treatment works) and safety (how well it is tolerated), using comparisons with semaglutide or placebo.
Who the trials are for
One trial is for participants living with obesity who do not have diabetes.
Another trial is for participants living with obesity or overweight and diabetes.
The third trial is for participants living with obesity or overweight with weight-related comorbidities and who do not have diabetes.
A comorbidity is another health problem that happens along with the main condition.
Trial phases and study design
All three studies are Phase 3 trials, which means they are late-stage studies in larger groups of people.
Each study is interventional, meaning researchers assign a treatment and then measure the results.
In one trial, KAI-9531 is compared with semaglutide and placebo.
In the other two trials, KAI-9531 is compared with placebo.
Main endpoints and what they mean
The main outcome in two studies is percent change in body weight from the start of the trial to Week 76.
The study in participants with diabetes also measures change in hemoglobin A1c at Week 76.
Hemoglobin A1c is a blood test that shows average blood sugar over time, so it helps researchers see whether blood sugar control changes during the study.
The trial comparing KAI-9531 with semaglutide is designed to show that KAI-9531 is better than semaglutide and placebo for percent change in body weight.
The study in people with diabetes is designed to show that KAI-9531 is better than placebo for both body weight change and HbA1c change.
Trial summary
| Trial ID | Title | Condition | Phase | Status | Enrollment | Primary outcome |
|---|---|---|---|---|---|---|
| NCT07284979 | Efficacy and Safety of KAI-9531 compared with Semaglutide in Participants Living With Obesity Who Do Not Have Diabetes | Obesity | Phase 3 | Authorised | 1200 | Percent change in body weight at Week 76 |
| NCT07284901 | Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight and Diabetes | Obesity | Phase 3 | Authorised | 1700 | Percent change in body weight and change in hemoglobin A1c at Week 76 |
| NCT07284875 | Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes | Obesity | Phase 3 | Authorised | 1800 | Percent change in body weight at Week 76 |