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PasGras

Not yet recruitingPhase NA

Prevent and Reverse Obesity in Children, Adolescents and Young Adults

De-Risking Metabolic, Environmental and Behavioral Determinants of Obesity in Children, Adolescents and Young Adults

Lead sponsor

piero portincasa

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥25

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07035704

Org study IDPasGras 2025

Timeline

Milestones

Study first posted2025-06-25actual

Last update posted2025-06-25actual

Study start2025-09-15estimated

Primary completion2027-01-30estimated

Study completion2027-03-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•18-55 years old overweight or obese men and women (BMI ≥ 25 kg/m2).

•Signed informed consent.

•Have a mobile phone, tablet, or computer with internet access.

Exclusion criteria

•Waist circumference > 150 cm

•Suffer from diabetes or other disorders of glucose metabolism

•Suffer from dyslipidemia or other alterations of lipid metabolism (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).

•Present chronic gastrointestinal problems such as Crohn's disease or irritable bowel syndrome.

•Present any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.

•Have a diagnosed liver disease other than steatotic liver disease.

•Taking supplements or multivitamin supplements or phototherapeutic products for weight loss that interfere with the study.

•Have taken antibiotics in the last 30 days.

•Follow a low-calorie diet and/or pharmacological treatment for weight loss.

•Being a smoker.

•Regular alcohol consumption (more than 4 Standard Drink Units (SDU) per day or 28 SDU per week.

•Have lost more than 3 kg of weight in the last 3 months.

•Suffering from eating disorders or psychiatric disorders.

•Present food intolerances and/or allergies related to the study products, such as allergy to edible mushrooms or fungal spores or to any of the components of the Lebanese herbal mixture Za'atar such as sesame seeds.

•Be pregnant or intend to become pregnant or be breastfeeding,

•Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.

•No or limited access to the Internet.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

MASH / liver

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

Weight (Kg)

Time frame:one year

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Abdominal fat storage

Time frame:one year

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Fasting glucose

Time frame:one year

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

MASH / liver

2 endpoints

Secondary/protocol endpoint

Liver enzymes

Time frame:one year

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Liver steatosis

Time frame:one year

descriptive, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Lipid profile (TC, TG, LDL, HDL)

Time frame:one year

change from baseline, improvement

Other/protocol endpoint

Inflammatory markers

Time frame:One year

descriptive

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Gut Microbiota

Time frame:one year

descriptive

Publications (19)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

'Obesities': Position statement on a complex disease entity with multifaceted drivers.
European journal of clinical investigation2022 Jul (month)PMID35514242doi:10.1111/eci.13811via CT.gov background
Relationship between Liver Stiffness and Steatosis in Obesity Conditions: In Vivo and In Vitro Studies.
Biomolecules2022 May 23PMID35625660doi:10.3390/biom12050733via CT.gov background
Synergistic and Detrimental Effects of Alcohol Intake on Progression of Liver Steatosis.
International journal of molecular sciences2022 Feb 27PMID35269779doi:10.3390/ijms23052636via CT.gov background
Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis.
International journal of molecular sciences2022 Jan 20PMID35163038doi:10.3390/ijms23031105via CT.gov background
Intestinal Barrier and Permeability in Health, Obesity and NAFLD.
Biomedicines2021 Dec 31PMID35052763doi:10.3390/biomedicines10010083via CT.gov background
Extent and features of liver steatosis in vitro pave the way to endothelial dysfunction without physical cell-to-cell contact.
Nutrition, metabolism, and cardiovascular diseases : NMCD2021 Nov 29PMID34629256doi:10.1016/j.numecd.2021.08.032via CT.gov background
An Innovative Synbiotic Formulation Decreases Free Serum Indoxyl Sulfate, Small Intestine Permeability and Ameliorates Gastrointestinal Symptoms in a Randomized Pilot Trial in Stage IIIb-IV CKD Patients.
Toxins2021 May 5PMID34063068doi:10.3390/toxins13050334via CT.gov background
((13)C)-Methacetin breath test provides evidence of subclinical liver dysfunction linked to fat storage but not lifestyle.
JHEP reports : innovation in hepatology2021 Feb (month)PMID33490935doi:10.1016/j.jhepr.2020.100203via CT.gov background
Childhood obesity, cardiovascular and liver health: a growing epidemic with age.
World journal of pediatrics : WJP2020 Oct (month)PMID32020441doi:10.1007/s12519-020-00341-9via CT.gov background
Liver Steatosis, Gut-Liver Axis, Microbiome and Environmental Factors. A Never-Ending Bidirectional Cross-Talk.
Journal of clinical medicine2020 Aug 14PMID32823983doi:10.3390/jcm9082648via CT.gov background
Blood-based test for diagnosis and functional subtyping of familial Mediterranean fever.
Annals of the rheumatic diseases2020 Jul (month)PMID32312770doi:10.1136/annrheumdis-2019-216701via CT.gov background
The Controversial Role of Human Gut Lachnospiraceae.
Microorganisms2020 Apr 15PMID32326636doi:10.3390/microorganisms8040573via CT.gov background
Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients.
European journal of clinical investigation2020 Mar (month)PMID31960952doi:10.1111/eci.13201via CT.gov background
Increased Colonic Permeability and Lifestyles as Contributing Factors to Obesity and Liver Steatosis.
Nutrients2020 Feb 21PMID32098159doi:10.3390/nu12020564via CT.gov background
Sourdough Fermented Breads are More Digestible than Those Started with Baker's Yeast Alone: An In Vivo Challenge Dissecting Distinct Gastrointestinal Responses.
Nutrients2019 Dec 4PMID31817104doi:10.3390/nu11122954via CT.gov background
Diet and Contaminants: Driving the Rise to Obesity Epidemics?
Current medicinal chemistry2019 (year)PMID28521687doi:10.2174/0929867324666170518095736via CT.gov background
Obesity phenotypes and their paradoxical association with cardiovascular diseases.
European journal of internal medicine2018 Feb (month)PMID29100895doi:10.1016/j.ejim.2017.10.020via CT.gov background
The dangerous link between childhood and adulthood predictors of obesity and metabolic syndrome.
Internal and emergency medicine2016 Mar (month)PMID26758061doi:10.1007/s11739-015-1382-6via CT.gov background
Obesity and the risk and prognosis of gallstone disease and pancreatitis.
Best practice & research. Clinical gastroenterology2014 Aug (month)PMID25194180doi:10.1016/j.bpg.2014.07.013via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.