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

"{\n \"timeline\": [\n {\n \"step\": \"study start and group assignment\",\n \"step_number\": \"1\",\n \"details\": [\n \"After you join the study, you are assigned to one of the study groups by chance. This is called randomization, which means a computer-like process decides the group, not the patient or the study team.\",\n \"The study is double-blind, which means you do not know whether you are receiving KAI-9531 or placebo. A placebo is a liquid injection that looks the same as the study medicine but does not contain the active drug.\",\n \"The study medicine is given as a subcutaneous injection, which means an injection under the skin.\"\n ]\n },\n {\n \"step\": \"weekly treatment period\",\n \"step_number\": \"2\",\n \"details\": [\n \"You receive the study treatment once weekly for up to 76 weeks.\",\n \"If you are assigned to the active treatment group, you receive KAI-9531 as a solution for injection under the skin. The source data list the dose as 00 mg.\",\n \"If you are assigned to the comparison group, you receive placebo instead of the active drug. The placebo is described as identical to the KAI-9531 solution for injection without active drug.\",\n \"The trial compares the effect of KAI-9531 with placebo on change in body weight over time.\"\n ]\n },\n {\n \"step\": \"study measurements during treatment\",\n \"step_number\": \"3\",\n \"details\": [\n \"During the trial, your body weight is measured and compared with your starting weight.\",\n \"Your waist size is measured.\",\n \"Your body mass index, or bmi (a measure based on height and weight), is measured.\",\n \"Your blood pressure is measured, including sbp (top blood pressure number) and dbp (bottom blood pressure number).\",\n \"Blood tests are taken to check fats in the blood, including triglycerides, hdl-cholesterol (often called good cholesterol), non-hdl-cholesterol, total cholesterol, ldl-cholesterol (often called bad cholesterol), and vldl-cholesterol.\",\n \"Blood tests are also taken to check fasting insulin and fasting blood glucose, which means blood sugar measured after not eating for a period of time.\",\n \"You complete questionnaires about physical function and quality of life, including iwqol-lite-ct and coeq. These are study questionnaires about how weight affects daily life and overall health experience.\",\n \"You have ecgs, or electrocardiograms, which are tests that record the heart's electrical activity.\",\n \"Your vital signs are checked. Vital signs are basic body measurements such as pulse, blood pressure, and temperature.\",\n \"The study also checks for teaes, which means treatment-emergent adverse events. These are health problems that appear or worsen after treatment starts.\",\n \"The study measures ada nab, which means antibodies against the drug that may be made by the body.\",\n \"The study also evaluates population pk, which means how the study medicine moves through the body.\"\n ]\n },\n {\n \"step\": \"end of week 76 evaluation\",\n \"step_number\": \"4\",\n \"details\": [\n \"At week 76, your change in body weight from the start of the study is assessed.\",\n \"The study checks how many participants have lost at least 5%, 10%, 15%, 20%, 25%, or 30% of body weight.\",\n \"The study also measures changes in your waist size, body mass index, body weight, blood pressure, blood fats, fasting insulin, fasting blood glucose, and questionnaire scores.\"\n ]\n },\n {\n \"step\": \"study duration\",\n \"step_number\": \"5\",\n \"details\": [\n \"The study is planned to run from 2026-06-25 to 2028-03-27.\"\n ]\n }\n ]\n}"