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

The dose regimen selected for this study is based on the safety and tolerability data generated in the preceding SERENITY First-in-Human study. In the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) parts of that study, total daily doses of 12 mg, 24 mg and up to 45 mg/day (administered as 15 mg three times daily) were evaluated. The highest MAD regimen (45 mg/day) was administered for 30 consecutive days and was considered acceptable from a safety and tolerability perspective. For the present study, a total daily dose of 15 mg (7.5 mg administered twice daily) has been selected. This regimen represents a substantially lower daily exposure than the highest dose previously evaluated in humans (15 mg/day versus 45 mg/day), thereby providing an adequate safety margin to support the planned longer treatment duration of 90 days. The selected dose is expected to provide sufficient pharmacological activity while minimizing overall drug exposure and maintaining an acceptable safety profile during prolonged administration. Considering the exploratory objectives of this study, the 7.5 mg twice-daily regimen is considered an appropriate balance between the anticipated pharmacodynamic effect and long-term safety. Patients will come to the clinical site 3 times. The eligibility of obese participants will be checked at initial visit (screening visit V0) by the healthcare professional and with first 3AFC method. Volunteers will be then randomized at 2:1 ratio between NKS-3 and matched placebo. Blood parameters will be measured before the test. The first product intake will be done at the study center then volunteers will have a 2nd dose at home before dinner. Before discharge from the study site, participants will receive appropriate training and instructions from qualified study personnel regarding the correct administration of the investigational product, including the timing of dosing, storage conditions, and the actions to be taken in the event of a missed dose. Participant understanding will be confirmed prior to home administration. The dose will remain 7.5 mg, 2 times a day (morning and evening before main meal) during the next 45 days. After 45 days the patient will come to the center for V1 and will pursue after clinical exam the test for 45 additional days. At the end of the study the patient will come to the site for V2. Treatment compliance will be assessed at each study visit through participant interview and study product accountability (returned sachet count). Additional telephone contacts may be performed between visits to reinforce compliance and assess participant safety. These contacts and any clinically relevant information obtained will be documented in the participant's CRF/eCRF.