A PHASE 2A, EXPLORATORY, RANDOMIZED, SINGLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY OF WEIGHT LOSS INDUCED BY NKS-3 IN OBESE ADULTS.

Who cannot join

• E1. Presence of any clinically significant or inadequately controlled metabolic or endocrine disorder that may interfere with study participation, participant safety or interpretation of efficacy outcomes, including but not limited to uncontrolled diabetes mellitus, untreated or inadequately controlled thyroid disease, Cushing syndrome, or another clinically relevant endocrine disorder.
• E2. Presence of any severe, active, uncontrolled or clinically significant chronic disease, including clinically relevant cardiovascular, hepatic, renal, gastrointestinal, neurological or other systemic disease, which, in the Investigator's opinion, may compromise participant safety, interfere with study procedures or investigational product administration, or affect interpretation of the study results, E3. With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients, E4. Subjects receiving medications or dietary supplements known to significantly influence body weight, appetite, energy metabolism, or oro-sensory perception (including but not limited to GLP-1 receptor agonists, anti-obesity medications, systemic corticosteroids, SGLT2 inhibitors, or centrally acting appetite suppressants), unless discontinued for a period exceeding five elimination half-lives before screening.
• E5. Clinically relevant changes in dietary habits, alcohol consumption, or physical activity during the three months preceding screening, as determined by investigator interview, or unwillingness to maintain stable lifestyle habits throughout study participation.
• E6. Subjects currently on a specific diet (hyper or hypocaloric, vegan, vegetarian), who stopped a specific diet less than 3 months before the screening visit, or who plan to initiate a specific diet during the study, E7. Subjects with a history of weight loss surgery, E8. Having lost their sense of taste and not fully regained it following an infection with SARS-CoV-2.
• E9. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator, E10. Consuming more than 2 standard drinks of alcoholic beverage daily, E11. Taking part in another clinical trial or having taken part in a clinical trial within 3 months before the screening visit, except participation in previous SERENITY studies when specifically permitted by the Sponsor and provided that all protocol-defined eligibility criteria are fulfilled.
• E12. Female participant is pregnant as determined by positive serum pregnancy test at the screening visit E13. Breast-feeding female participants E14. Under legal protection (guardianship, wardship) or deprived of rights following administrative or judicial decision, E15. Presenting a psychological or linguistic incapability to sign the informed consent, E16. Clinically significant psychiatric illness or any other condition that, in the opinion of the Investigator, may compromise participant safety, protocol compliance, or the validity of the study results.
• E17. Impossible to contact in case of emergency.