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HRS 9531

Clinical trials are investigating TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AMINOETHOXY]ETHOXY]ACETYL-[2-[2-AMINOETHOXY]ETHOXY]ACETYL-GAMMA-GLUTAMYL-EICOSANOYL)-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL AMIDE, also called KAI-9531, for weight loss and related health problems. These studies mainly look at safety and how well it works in adults with obesity, overweight, and sometimes diabetes. All listed trials are Phase 3 and are authorised.

Table of contents

Overview of the trials

These studies investigate TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AMINOETHOXY]ETHOXY]ACETYL-[2-[2-AMINOETHOXY]ETHOXY]ACETYL-GAMMA-GLUTAMYL-EICOSANOYL)-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL AMIDE, also called KAI-9531, in people living with obesity and related conditions.[1][2][3]

Across the three listed studies, researchers are mainly looking at whether KAI-9531 can improve body weight outcomes and, in one study, blood sugar control measured by hemoglobin A1c.[1][2]

Who can participate

The target groups are adults with obesity, adults with obesity who do not have diabetes, adults with obesity or overweight and diabetes, and adults with obesity or overweight who also have weight-related comorbidities.[1][2][3]

The exact group depends on the trial, so each study focuses on a slightly different patient population.[1][2][3]

Trial phase and status

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

Every listed trial has the status Authorised.[1][2][3]

Main endpoints

The main endpoint in most trials is percent change in body weight from baseline at Week 76.[1][3]

One study also measures change in hemoglobin A1c at Week 76, which is a blood test that shows average blood sugar over time.[2]

Trial-by-trial details

NCT07284979 includes 1,200 participants with obesity who do not have diabetes.[1] The study compares KAI-9531 with semaglutide and placebo, and its brief summary says the goal is to show that KAI-9531 once weekly is superior on percent change in body weight.[1]

NCT07284901 includes 1,700 participants with obesity or overweight and diabetes.[2] This study compares KAI-9531 with placebo and aims to show better results for body weight and hemoglobin A1c.[2]

NCT07284875 includes 1,800 participants with obesity or overweight plus weight-related comorbidities, and they do not have diabetes.[3] The study compares KAI-9531 with placebo and focuses on percent change in body weight.[3]

Key terms explained

  • Interventional study: a study where researchers give a treatment and compare the results between groups.[1]

  • Placebo: a look-alike treatment without active drug, used to make the comparison fair.[1]

  • Baseline: the starting point before treatment begins.[1]

  • Enrollment: the number of participants planned for the study.[1]

  • Comorbidity: another health problem that occurs together with the main condition.[3]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT07284979 Phase 3 Obesity; participants living with obesity who do not have diabetes Authorised 1200 Percent change in body weight from baseline at Week 76
NCT07284901 Phase 3 Obesity; overweight and diabetes Authorised 1700 Percent change in body weight from baseline at Week 76; change in hemoglobin A1c at Week 76
NCT07284875 Phase 3 Obesity; overweight with weight-related comorbidities, without diabetes Authorised 1800 Percent change in body weight from baseline at Week 76

FAQ

  • What is being studied in these trials? The trials study TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AMINOETHOXY]ETHOXY]ACETYL-[2-[2-AMINOETHOXY]ETHOXY]ACETYL-GAMMA-GLUTAMYL-EICOSANOYL)-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL AMIDE, also named KAI-9531. The main goal is to see whether it helps reduce body weight and whether it is safe.
  • Who can take part in these studies? The trials include adults living with obesity, adults who are overweight with weight-related comorbidities, and adults living with obesity or overweight and diabetes. The exact group depends on the specific trial.
  • What phase are the trials in? All three listed studies are Phase 3 trials. This means they are late-stage studies that test how well the treatment works and continue to monitor safety in larger groups.
  • What conditions are being studied? The main condition is obesity. Some trials also include overweight with weight-related comorbidities, and one trial includes diabetes.
  • What outcome measures are being used? The main outcome in most trials is percent change in body weight from baseline at Week 76. One trial also measures change in hemoglobin A1c, which is a blood test that shows average blood sugar over time.

Sperimentazioni cliniche in corso su HRS 9531

  • Studio di fase 3 su obesità o sovrappeso con comorbidità correlate al peso, senza diabete, con KAI-9531 e placebo in adulti

    Arruolamento non iniziato

    1 1
    Malattie in studio:
    Farmaci in studio:
    Bulgaria Cechia Germania Ungheria Polonia Spagna

  • Studio di fase 3 su KAI-9531 in pazienti con obesità o sovrappeso e diabete di tipo 2

    Arruolamento non iniziato

    1 1
    Malattie in studio:
    Farmaci in studio:
    Bulgaria Cechia Germania Ungheria Polonia Spagna

  • Studio sull’efficacia e sicurezza di KAI-9531 e semaglutide in persone con obesità che non hanno il diabete

    Arruolamento non iniziato

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Bulgaria Polonia

Glossario

  • Obesity: A medical condition where a person has too much body fat, which can raise the risk of other health problems.
  • Overweight: A body weight above the healthy range, but not always as high as obesity.
  • Weight-related comorbidities: Other health problems that happen together with excess weight, such as conditions made worse by being overweight.
  • Diabetes: A disease in which blood sugar is too high because the body does not use insulin properly.
  • Phase 3: A late stage of clinical research done in larger groups to check how well a treatment works and to keep watching safety.
  • Interventional study: A study where researchers give a treatment and compare results between groups.
  • Placebo: A look-alike treatment without active drug, used to compare results fairly.
  • Semaglutide: A treatment used as a comparator in one trial. The trial compares KAI-9531 with semaglutide.
  • Hemoglobin A1c: A blood test that shows average blood sugar over about 3 months.
  • Baseline: The starting point before the trial treatment begins.
  • Week 76: The time point used in these studies to measure the main results after treatment.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sull-efficacia-e-sicurezza-di-kai-9531-e-semaglutide-in-persone-con-obesita-che-non-hanno-il-diabete/
  2. https://studi-clinici.it/studio/studio-sull-efficacia-e-la-sicurezza-di-kai-9531-in-persone-con-obesita-o-sovrappeso-e-diabete/
  3. https://studi-clinici.it/studio/studio-sull-efficacia-e-la-sicurezza-di-kai-9531-in-persone-con-obesita-o-sovrappeso-con-problemi-di-salute-correlati-che-non-soffrono-di-diabete/