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HRS 9531

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.

Table of contents

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.[1][2][3]

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.[1][2][3]

Who the trials are for

One trial is for participants living with obesity who do not have diabetes.[1]

Another trial is for participants living with obesity or overweight and diabetes.[2]

The third trial is for participants living with obesity or overweight with weight-related comorbidities and who do not have diabetes.[3]

A comorbidity is another health problem that happens along with the main condition.[3]

Trial phases and study design

All three studies are Phase 3 trials, which means they are late-stage studies in larger groups of people.[1][2][3]

Each study is interventional, meaning researchers assign a treatment and then measure the results.[1][2][3]

In one trial, KAI-9531 is compared with semaglutide and placebo.[1]

In the other two trials, KAI-9531 is compared with placebo.[2][3]

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.[1][3]

The study in participants with diabetes also measures change in hemoglobin A1c at Week 76.[2]

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.[2]

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.[1]

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.[2]

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
Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT07284979 Phase 3 Obesity, without diabetes Authorised 1200 Percent change in body weight at Week 76
NCT07284901 Phase 3 Obesity or overweight and diabetes Authorised 1700 Percent change in body weight and change in hemoglobin A1c at Week 76
NCT07284875 Phase 3 Obesity or overweight with weight-related comorbidities, without diabetes Authorised 1800 Percent change in body weight at Week 76

FAQ

  • What is being studied in these trials? The trials are studying KAI-9531 in adults with obesity, and in one study, adults with obesity or overweight and diabetes. The main goal is to see how well it works for weight loss and, in the diabetes study, blood sugar control.
  • Who can take part in the studies? The target groups are adults living with obesity, adults with obesity or overweight plus weight-related health problems, and adults with obesity or overweight and diabetes. The exact entry rules are not listed in the trial data provided.
  • What phase are these trials? All three trials are Phase 3 studies. Phase 3 means the treatment is being tested in a larger group of people to compare benefits and safety against another treatment or placebo.
  • What outcomes are the trials measuring? The main outcome in two studies is percent change in body weight at Week 76. One study also measures change in hemoglobin A1c, which is a blood test that shows average blood sugar over time.
  • How many people are planned for these studies? The planned enrollment is 1,200 people in one study, 1,700 in another, and 1,800 in the third. Together, these trials are designed to include a large number of participants.

Ongoing Clinical Trials on HRS 9531

  • Study of KAI-9531 in Adults With Obesity or Overweight and Weight-Related Health Problems Without Diabetes

    Recruiting

    3 1
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland Spain

  • KAI-9531 in Adults With Obesity or Overweight and Diabetes

    Not yet recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland Spain

  • Comparing the efficacy and safety of KAI-9531 and semaglutide in people living with obesity who do not have diabetes

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Poland

Glossary

  • Obesity: A condition where a person has too much body fat, which can raise the risk of health problems.
  • Overweight: A body weight that is higher than what is considered healthy for a person’s height.
  • Diabetes: A long-term condition where blood sugar is too high.
  • Weight-related comorbidities: Other health problems that happen along with excess weight, such as conditions linked to obesity or overweight.
  • Phase 3: A late stage of clinical testing in a larger group of people, usually to compare a treatment with another treatment or placebo.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Placebo: An inactive treatment used for comparison in a trial.
  • Semaglutide: A treatment used as a comparison in one of the trials.
  • Hemoglobin A1c: A blood test that shows average blood sugar levels over about 2 to 3 months.
  • Percent change in body weight: How much body weight changes compared with the starting weight, shown as a percentage.
  • Week 76: The time point used in these trials for the main outcome, about 76 weeks after the start of the study.
  • Enrollment: The number of people planned to join a study.

References