Weight and Metabolic Management Study

Prior treatment

• Previous or current use of elénzia CONTROL®.
• Current use of anorexigenic medications, including sibutramine, bupropion for weight-loss indication, liraglutide, topiramate, orlistat, fluoxetine when used for appetite suppression, cannabinoids, medroxyprogesterone, megestrol, or systemic corticosteroids used as appetite stimulants.
• Current participation in another interventional clinical trial, or participation in an interventional study within the previous 30 days.

Other illness

• Known hypersensitivity or allergy to any component of elénzia CONTROL® or the placebo, including citrus flavonoids, milk thistle extract, bitter melon extract, iodine, zinc, selenium or chromium.
• Diagnosis of type 1 or type 2 diabetes mellitus.
• History of significant endocrine disorders, including Cushing's disease or Addison's disease.
• Chronic illnesses that may significantly affect food intake, weight regulation or metabolic status, including active malignancy, advanced liver disease, renal failure or acquired immunodeficiency syndrome (AIDS).

Lab values

• Current use of herbal or other dietary supplements specifically intended for weight loss, appetite control, fat burning, or blood glucose regulation.

Other

• Current smoking or use of nicotine-containing products.
• Pregnancy or breastfeeding.
• Current use of insulin, sulfonylureas (e.g. gliclazide, glimepiride), warfarin, lithium, amiodarone, high-dose iodine supplements.

• Adults aged 25 to 65 years inclusive at the time of consent.
• Participants must fall into one of the following cohorts:
• GLP-1-naïve cohort: individuals who have never used GLP-1 receptor agonist medications.
• Post-GLP-1 cohort: individuals who have discontinued GLP-1 receptor agonist therapy, with the last injection taken prior to enrolment.
• Body mass index (BMI), calculated using self-reported height and weight at screening:
• GLP-1-naïve cohort: BMI ≥27 kg/m² and \<40 kg/m².
• Post-GLP-1 cohort: BMI \<40 kg/m², with no lower BMI limit.
• Participants entering the post-GLP-1 cohort must have been on a stable GLP-1 receptor agonist dose for at least 6 months and achieved at least 10% body-weight reduction prior to discontinuation.
• Participants must be capable of providing informed consent independently and demonstrate understanding of the study requirements.
• Participants must be willing and able to complete study procedures remotely through a mobile application, provide self-measured weight and waist circumference data, and take the allocated study capsules daily as instructed.
• Participants must have access to a compatible smartphone, reliable internet access, and their own home weighing scale.
  • Additional participant characteristics: A prior diagnosis of prediabetes, insulin resistance, or polycystic ovary syndrome (PCOS) may be self-reported at screening for study population characterisation and subgroup analyses. These conditions are not required for eligibility and do not determine inclusion in the study.