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Cette étude clinique vise à tester un nouveau traitement appelé comprimés CX11 pour aider à réduire le poids corporel chez les personnes en surpoids ou obèses. L'étude est importante car elle vise à trouver une méthode efficace et sûre pour aider les personnes luttant contre les problèmes de poids, qui peuvent entraîner divers problèmes de santé. En comparant différentes doses de comprimés CX11 à un placebo, les chercheurs espèrent déterminer quelle dose, le cas échéant, est la plus efficace pour aider à la perte de poids et améliorer les indicateurs de santé liés au poids. Les participants à l'étude se verront attribuer au hasard soit différentes doses de comprimés CX11, soit un placebo, garantissant que les résultats de l'étude sont impartiaux. Le traitement durera 36 semaines, suivi d'une période d'observation de 2 semaines pour vérifier tout problème de sécurité. Les chercheurs évalueront l'efficacité des comprimés en mesurant les changements de poids corporel et des indicateurs de santé connexes tout au long de l'étude. De plus, l'étude évaluera la tolérance des participants aux comprimés et surveillera leur sécurité, garantissant que les risques sont minimisés.
Inclusion Criteria Participants who meet all of the following criteria will be eligible to participate in this study: * Between 18 and 75 years old. Both men and women can participate, but women may make up to 70% of the participants. * BMI of 30 or higher, or a BMI between 27 and 30 with at least one related health condition such as prediabetes, high blood pressure, abnormal cholesterol levels, fatty liver, or sleep apnea due to being overweight. * HbA1c level below 6.5% and fasting blood sugar levels below 126 mg/dL. * Have tried and failed to lose weight through diet and exercise at least once before the study and must have had a stable body weight (less than a 5% change) in the 90 days before the study. * Participants and their partners must not plan to become pregnant or donate sperm/eggs during the study and for 90 days after. They must agree to use effective contraception for at least 6 months prior to screening and continue their chosen contraception method throughout the study. Women who could become pregnant must have a negative pregnancy test 24 hours before the first dose of study drug. * Willing to maintain a stable diet and exercise routine during the study and keep a diary of their activities. * Understand the study procedures, be willing to follow the study rules strictly, and sign a consent form voluntarily. Exclusion Criteria Participants who meet any of the following criteria will be excluded from this study: * Known or suspected hypersensitivity to GLP-1 receptor agonists or similar products. * Took part in another clinical study and received treatment within the last 90 days or within 5 drug elimination half-lives. * Any type of diabetes. * Obesity caused by hormonal or genetic issues such as thyroid problems, Cushing's syndrome, or other specific conditions. * Have had or plan to have obesity treatment surgery or use weight loss devices, with some exceptions if done over a year ago. * Have used certain medications or therapies for weight loss or conditions affecting weight, including GLP-1 receptor agonists and other related drugs, within the last 90 days. * Recent serious heart problems, uncontrolled high blood pressure, or certain ECG abnormalities. * History of pancreatitis, gallbladder disease (except for those treated with cholecystectomy), or evidence of hypothyroidism (except for participants who have normal thyroid function at screening and have been on a stable dose thyroid replacement for at least 90 days and are expected to maintain a stable dose during the study) or hyperthyroidism or thyrotoxicosis. * History of cancer in the last 5 years, except for localized basal or squamous skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer. * Serious gastrointestinal diseases or surgeries that affect drug absorption. * Active liver disease, excluding nonalcoholic fatty liver disease. * Other serious health conditions that could increase study risk or make participation inappropriate, including certain psychiatric disorders. * Recent history of unexplained fainting or family history of long QT syndrome or sudden death. * History of organ transplant or severe autoimmune diseases. * Had major surgery within the last 6 months or plan to have surgery soon. * Significant abnormalities in kidney function, liver enzymes, blood tests, or other specified lab results. * Positive for hepatitis B, hepatitis C, or HIV. * Donated blood, lost a lot of blood, or received a transfusion in the last 90 days. * Exceed weekly alcohol intake limits or have a history of drug abuse (including cannabis, its derivatives, or any cannabis-containing products; except for prescribed drug for medical purpose). * Women who are pregnant or breastfeeding. * Any other disease, condition, or medication that the investigator believes would interfere with the study.
sont désignés dans cette étude
d'être dans le groupe placebo en aveugle