A Phase 1 interventional study of NKS-3 and NKS-5 in Obesity & Overweight and Overweight (BMI > 30), sponsored by EktaH. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by EktaH · Phase 1, Interventional, and Treatment
This study is designed as a single ascending dose and multiple ascending dose single-blind, placebo controlled, randomized, monocentric trial. 60 obese men and women will be recruited for single ascending dose (Groups 1,2,3), according to the following inclusion and non-inclusion criteria.
60 obese men and women will be recruited for multiple ascending doses (Groups 4,5,6), according to the following inclusion and non-inclusion criteria.
Patients will come to the clinical site 3 times for SAD or 4 times for MAD + efficacy and have a telephone call 14 days after the end of the study. A patient is allowed participate to the single ascending dose and pursue with the multiple ascending dose and efficacy phase.
The eligibility of obese will be checked at initial visit (screening visit V0) by the healthcare professional and with first 3AFC test.
Volunteers will be randomized at visit V1 and a second 3 AFC test will be performed.
The first 20 obese (group 1) will start at the smallest single dose level (12mg of NKS-3 salt, NKS-5 oil + Arabic gum or water / water + Arabic gum) Blood parameters will be measured before the test. The product intake will be done at the center. Next day, after 12 hours fasting, blood parameters will be measured.
The next 20 obese (group 2) will only start if no adverse events are reported. Once again, blood parameters will be measured before the test. The product intake (24mg) will be done at the center. Next day, after 12 hours fasting, blood parameters will be measured.
The next 20 obese (group 3) will only start if no adverse events are reported. Once again, blood parameters will be measured before the test. The product intake (150mg) will be done at the center. Next day, after 12 hours fasting, blood parameters will be measured.
The next 20 obese and 6 healthy volunteers (group 4) will only start if no adverse events are reported. Once again, blood parameters will be measured before the test. The 1st product intake (4mg) will be done at the center before breakfast, then volunteers will have a 2nd dose (4mg) at home before lunch and a 3rd at home before dinner. The dose will remain 4mg 3 times a day during the first 5 days. If no adverse events are reported, volunteers will have a 8mg dose 3 times a day during the next 5 days and a 15mg dose 3 times a day for the last 5 days The next 20 obese and 6 healthy volunteers (group 5) will only start if no adverse events are reported during the first 5 days of group 4. Once again, blood parameters will be measured before the test. The 1st product intake (8mg) will be done at the center before breakfast, then volunteers will have a 2nd dose (8mg) at home before lunch and a 3rd at home before dinner. The dose will remain 8mg 3 times a day during the first 5 days. If no adverse events are reported, volunteers will have a 15mg dose 3 times a day during the next 10 days The next 20 obese and 6 healthy volunteers (group 6) will only start if no adverse events are reported during the first 5 days of group 5. Once again, blood parameters will be measured before the test. The 1st product intake (15mg) will be done at the center before breakfast, then volunteers will have a 2nd dose (15mg) at home before lunch and a 3rd at home before dinner. The dose will remain 15mg 3 times a day during the next 15 days.
If no adverse events are reported, volunteers will have the possibility to continue the product intake at 15mg dose 3 times a day for an additional 15 days.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →EktaH is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Obese adults and healthy patients to be administered the treatment NKS-3
Drug: NKS-3
Obese adults and healthy patients to be administered the treatment NKS-5
Drug: NKS-5
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
Investigational product is a modified linoleic acid, named NKS-5. This non-caloric agent, synthetized from linoleic acid, is a fat taste receptors agonist, targeting CD36 with also an impact on GPR120
Assess the release of satiety peptides (PYY, CCK, GLP-1) at different doses
The primary endpoint of the study is to measure the release of satiety peptides (PYY, CCK, GLP-1) at different doses and during different periods of time of intake modified linoleic acids (NKS-3 salt or NKS-5 oil). This natural secretion should reduce volunteers' food intake and impact body weight.
Time frame: 8 to 10 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Assess the tolerance of modified linoleic acids NKS-3 and NKS-5 at 12mg ; 24mg ; 150mg single dose. Assess the tolerance after multiple ascending dose (15 days) intake of modified linoleic acid NKS-3 salt and NKS-5 oil at 12mg ; 24mg ; 45mg. Measure the number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Time frame: 8 to 10 weeks
To determine the orosensory detection threshold of modified linoleic acids NKS-5 oil and NKS-3 salt compare to linoleic acid
To determine the orosensory detection threshold of modified linoleic acids NKS-5 oil and NKS-3 salt compare to linoleic acid by the 3AFC Method. Measuring the response to increase amount of linoleic acid consumption.
Time frame: 8 to 10 weeks
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 completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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