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KAI-9531 in Adults With Obesity or Overweight and Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being done in obesity and diabetes to see whether KAI-9531, given as a subcutaneous injection once a week, can help lower body weight and improve blood sugar control. The trial also includes placebo. HbA1c is a blood test that shows average blood sugar over the past few months.

People in the study are assigned by chance to receive either KAI-9531 or placebo, and neither the participants nor the study team know which one is being given during the trial. Treatment is given over a long period, with regular study visits while the injections continue. The purpose of the study is to understand the efficacy and safety of KAI-9531 in people living with obesity or overweight and diabetes.

During the study, body weight, blood sugar, and other health measures are checked over time. The study also looks at possible side effects and at whether the body makes antibodies, which are proteins the immune system can form against a medicine. This information helps show how the treatment works and how safe it is for people taking it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study treatment begins</b>

    After joining the study, you start receiving kai-9531 or placebo. the study is randomized, which means the treatment is assigned by chance.

    The study is double-blind, which means that you and the study staff do not know whether you are receiving kai-9531 or placebo.

    kai-9531 is given as a subcutaneous injection, which means an injection under the skin.

    The medicine is given once weekly, meaning one time every week.

    The planned study dose for kai-9531 is listed as 00 mg. the source data do not provide a usable active dose amount.

  2. Step 2

    <b>weekly treatment period</b>

    You continue with the assigned injection once weekly during the treatment period.

    The treatment period lasts until the end of the study follow-up described in the trial. the source data do not list the full visit schedule or the number of injections.

    The study compares kai-9531 with placebo, which is an inactive solution that looks the same as the study medicine but does not contain the active drug.

  3. Step 3

    <b>study measurements during treatment</b>

    During the study, your body weight is measured. the main goal is to look at the percent change in body weight from the start of the study to week 76.

    Your hemoglobin a1c (hba1c) is checked. hba1c is a blood test that shows average blood sugar over the past few months.

    Other measurements may include waist size, absolute weight, fasting blood glucose (blood sugar after not eating), blood pressure, and blood fats such as triglycerides, hdl-cholesterol, non-hdl-cholesterol, total cholesterol, ldl-cholesterol, and vldl-cholesterol.

    Other study checks may include insulin levels, questions about eating behavior, and questions about how food thoughts affect you.

    The study may also check for treatment-emergent adverse events, which means new or worsening medical problems that appear after treatment starts.

    Blood tests may also look for antidrug antibodies and neutralizing antibodies, which are immune proteins that can react against the study medicine.

    The amount of kai-9531 in your body may also be measured.

  4. Step 4

    <b>week 76 assessment</b>

    The main results are assessed at week 76.

    The study checks whether your body weight has changed and whether your hba1c has changed from the start of the study.

    The study may also look at whether your weight has gone down by at least 5%, 10%, 15%, 20%, or 25%.

    Additional comparisons may include changes in waist size, bmi (body mass index, a number based on height and weight), blood sugar, blood pressure, blood fats, and questionnaire results.

  5. Step 5

    <b>end of study period</b>

    The planned study period ends by the stated study end date.

    The source data do not provide any further trial stages after the week 76 assessments and do not list any additional steps.

Who can join the trial?

5 criteria

  • Have a diagnosis of type 2 diabetes mellitus (T2DM), which means diabetes that the body does not manage well because it does not use insulin properly.
  • Have been on stable treatment for type 2 diabetes for at least 3 months before screening. Stable treatment means the diabetes treatment has not been changed during that time.
  • The stable diabetes treatment may be diet and exercise only, or a medicine taken by mouth for diabetes, but it must not include any of the following medicines: GLP-1 receptor agonists (medicines that help lower blood sugar and may reduce appetite), GLP-1/GIP dual agonists (medicines that act on two hormone targets to help control blood sugar and weight), or DPP-4 inhibitors (medicines that help the body release more insulin after meals).
  • Have a body mass index (BMI) of at least 27 kg/m². BMI is a number based on height and weight that helps estimate body fat.
  • Have a history of at least one unsuccessful attempt to lose weight using diet and exercise within the past 6 months.

Who cannot join the trial?

12 criteria

  • Current type 1 diabetes or any other type of diabetes other than type 2 diabetes.
  • A past suicide attempt.
  • Active or unstable major depressive disorder (a serious long-term depression) or another severe mental health disorder, such as schizophrenia (a condition that affects thinking and perception), bipolar disorder (a condition with extreme mood changes), or another serious mood or anxiety disorder, within the past 2 years.
  • Use of semaglutide, tirzepatide, GLP-1 receptor agonists (medicines that act like a gut hormone to lower blood sugar and often reduce appetite), GLP-1/GIP agonists (medicines that act on two gut hormone pathways), glucagon receptor agonists (medicines that affect blood sugar control), or other weight-loss medicines or treatments besides diet and exercise within the past 3 months.
  • A history of diabetic ketoacidosis (a dangerous buildup of acids in the blood) or hyperosmolar state/coma (a severe diabetes emergency with very high blood sugar and possible loss of consciousness) within the past 1 year.
  • A history of severe hypoglycemia (dangerously low blood sugar) or hypoglycemia unawareness (not noticing low blood sugar symptoms) within the past 1 year.
  • Starting medicines within the past 3 months that may cause significant weight gain, including tricyclic antidepressants (older antidepressants), atypical antipsychotics (medicines used for certain mental health conditions), and mood stabilizers (medicines that help control mood changes).
  • Unstable weight, meaning body weight changed by more than 5% in the past 3 months.
  • Personal or family history of multiple endocrine neoplasia type 2 (a rare inherited condition that causes hormone gland tumors) or medullary thyroid cancer (a type of thyroid cancer).
  • Uncontrolled hypertension (high blood pressure that is not well managed) or unstable cardiovascular disease (heart or blood vessel disease that is not stable).
  • History of pancreatitis, which is inflammation of the pancreas, either in the past or currently.
  • Known important problems with stomach emptying, such as severe gastroparesis (very slow stomach emptying), gastric outlet obstruction (a blockage that keeps food from leaving the stomach), or inflammatory bowel disease or irritable bowel syndrome if these are clinically significant, or long-term use of medicines that directly affect bowel movement for more than 30 days in a row within the past 3 months.
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Investigated drugs

KAI-9531 is the study medicine being tested in this trial. It is given as a shot under the skin once a week. The trial is checking whether it can help people with obesity or overweight and diabetes lose weight and improve blood sugar control compared with placebo.

What is already known about the treatment

  • KAI-9531

    KAI-9531 is given as a solution for injection under the skin, usually once weekly, using a small needle; this makes it a subcutaneous injectable medicine. It is still an investigational substance in medical research and is not yet a standard approved treatment in routine medical practice. It is being studied for obesity and diabetes because it is designed to help lower body weight and improve blood sugar control, likely by acting on body signals that affect appetite and metabolism; based on its complex peptide structure, it appears to belong to the class of long-acting hormone-like medicines.

  • Placebo

    The placebo is an injection that looks the same as the study medicine but contains no active drug, and it is given under the skin in the same way to keep the trial fair and blinded. It is not a treatment and has no place in medical therapy or medical literature as an active medicine, because it is used only as a comparison in research. It does not have a therapeutic indication or a molecular action, since it contains no substance intended to change the body’s function, and it is not classified as a pharmacological drug.

Investigated diseases

Obesity - Obesity is a condition in which excess body fat builds up to a level that is above healthy for a person's height. It usually develops gradually when body energy intake stays higher than energy use over time. As it progresses, body weight increases and fat may collect around the waist and other parts of the body. It can also be associated with changes in blood sugar, blood fats, and blood pressure.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523510-87-00Protocol codeK9531-3104Estimated enrolment1 236 patients

sourced from the EU Clinical Trials Register and site verification

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