A Phase 2 interventional study of Investigational product is a modified linoleic acid, named NKS-3. This non-caloric agent, synthetized from linoleic acid, is a fat taste receptors agonist, targeting CD36 with also an impact on GPR120 and Placebo solution in Obesity / Overweight and Obesity (BMI Equal to or >30), sponsored by EktaH. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by EktaH · Phase 2, Interventional, and Treatment
This study is designed as a single-blind, placebo-controlled, randomized, parallel-group trial. Subjects will be randomized in a 2:1 ratio to receive either NKS-3 or matching placebo, with a total planned enrollment of 31 subjects. During the 90-day treatment period, subjects will self-administer the assigned blinded study treatment daily at home. Given the exploratory nature of the study, which is intended to assess the feasibility of and generate preliminary evidence supporting the study hypothesis, a single-blind design has been selected. This approach reduces the logistical and organizational complexity associated with implementing a double-blind design while maintaining blinding of study participants to minimize expectation bias. Considering the exploratory objectives of the study, the selected design is considered appropriate and is not expected to compromise the scientific validity or the safety of participants.
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 31 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with EktaH as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
I1. Age between 18 and 60 years (limits included), I2. Obesity BMI ≥30.0 kg/m² and \<40.0 kg/m². I3. Nonsmokers (no cigarettes, nor electronic cigarettes), I4. Stable weight, defined by a weight variation of ± 5% during previous 3 months, I5. Clinically stable general physical and mental health, as determined by the Investigator on the basis of medical history, physical examination, vital signs and protocol-defined clinical laboratory assessments, with no clinically significant abnormality, uncontrolled medical condition or other finding that, in the Investigator's opinion, could compromise participant safety, interfere with study procedures, or affect interpretation of the study results.
I6. Able and willing to participate in the study and comply with the protocol procedures as evidenced by providing signed informed consent form, I7. Agree to be registered in biomedical research files as applicable. I8. Female participants of childbearing potential must agree to use a highly effective method of birth control until 15 days after the last dose of the study treatment. Acceptable methods include combined (estrogen- and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner (provided azoospermia has been confirmed and the partner is the sole sexual partner), or true sexual abstinence when this is the participant's established and preferred lifestyle I9. Female participants of childbearing potential must have a negative serum β-hCG pregnancy test at Screening before enrolment/randomization and a negative urine pregnancy test at Visit 1/Day 45 and Visit 2/Day 90 prior to investigational product
Exclusion Criteria:
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.
Drug: Investigational product is a modified linoleic acid, named NKS-3. This non-caloric agent, synthetized from linoleic acid, is a fat taste receptors agonist, targeting CD36 with also an impact on GPR120
Other: Placebo solution
Investigational product is a modified linoleic acid, named NKS-3. This non-caloric agent, synthetized from linoleic acid, is a fat taste receptors agonist, targeting CD36 with also an impact on GPR120.
Placebo solution with the group treated with NKS-3.
Evaluate the effect of NKS-3 compared with placebo on the percent change in body weight from baseline (V0) to Day 90 (V2) in adults with obesity.
The primary efficacy endpoint is the percent change in body weight from baseline (V0) to end of Treatment (V2, Day 90). The primary comparison will be the difference in percent body weight change between NKS-3 and placebo groups from baseline to day 90.
Time frame: 90 Days of treatment.
To evaluate the effect of NKS-3 compared with placebo on oro-sensory sensitivity to linoleic acid
To evaluate the effect of NKS-3 compared with placebo on oro-sensory sensitivity to linoleic acid, as assessed by the change in the linoleic-acid detection threshold using the 3-AFC method from baseline to Day 45 and Day 90. The secondary endpoint will be the oro-sensory detection thresholds (mmol/L) determined for each participant.
Time frame: 90 Days.
Start is estimated for Oct 2026; primary completion for Feb 2027, 3 months later.
Of 141 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 17. This study's planned 3 months is below that.
Counting every sponsor, half of 232 studies reached it within 15 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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