Weight and Metabolic Management with elénzia CONTROL in adults using or stopping GLP-1 weight loss meds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial investigates elénzia CONTROL®, a multi-ingredient nutritional supplement, for weight management in adults aged 25-65 who are either GLP-1-naïve or have recently discontinued GLP-1 therapy. Participants take two capsules daily, 30 minutes before the largest meal, for 16 weeks and use a mobile app to track lifestyle factors. The study will assess weight change and related outcomes such as appetite, cravings, mood, energy, diet, sleep, activity, stress, quality of life, and waist circumference to determine if the supplement supports weight maintenance or reduction after GLP-1 exposure. The trial uses a parallel, placebo-controlled design to compare elénzia CONTROL® with a look-alike placebo across two cohorts with separate analyses. Remote participation is enabled through mobile-app-provided data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Previous or current use of elénzia CONTROL®.
* Current smoking or use of nicotine-containing products.
* Pregnancy or breastfeeding.
* 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.
* Current use of insulin, sulfonylureas (e.g. gliclazide, glimepiride), warfarin, lithium, amiodarone, high-dose iodine supplements.
* Current use of herbal or other dietary supplements specifically intended for weight loss, appetite control, fat burning, or blood glucose regulation.
* 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.
* 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).
* Current participation in another interventional clinical trial, or participation in an interventional study within the previous 30 days.

Where it's running

• Elénzia
  Redditch, West Midlands, United Kingdom Recruiting

Study contacts

• Principal investigator: Godsfavour Oghifo, BPharm, MSc — elénzia
• Study coordinator: Godsfavour Oghifo
• Email: godsfavour@elenzia.com
• Phone: +44 7483 543042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.