Trials Sponsors Conditions Drugs Pricing

Conditions

Obesity (BMI Equal to or >30)Obesity / Overweight

Keywords

ObesityFat taste receptorOverweight

Outcome Measures

Primary Outcomes (1)

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.
90 Days of treatment.

Secondary Outcomes (1)

To evaluate the effect of NKS-3 compared with placebo on oro-sensory sensitivity to linoleic acid
90 Days.

Study Arms (2)

20 Obese adults to be administered the treatment NKS-3

ACTIVE COMPARATOR

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

11 obese adults to be administered placebo

PLACEBO COMPARATOR

Other: Placebo solution

Interventions

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 GPR120Drug

20 Obese adults to be administered the treatment NKS-3

Placebo solutionOther

Placebo solution with the group treated with NKS-3.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

EktaH
Industrylead

Study Sites (1)

Service des Maladies de la Nutrition A, Institut National de nutrition de Tunis

Tunis, 1007, Tunisia

Henda Pr. Jamoussi KamounCONTACT+ 216 98 648 225

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 12, 2026

First Posted

October 20, 2026

Study Start

October 20, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

February 5, 2027

You may not qualify if:

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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

20 Obese adults to be administered the treatment NKS-3

11 obese adults to be administered placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

20 Obese adults to be administered the treatment NKS-3

11 obese adults to be administered placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations