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Recruiting
NCT07789223
Weight and Metabolic Management Study
Conditions: Overweight, Obesity, Weight Maintenance
Sex: All
Ages: 25 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Elenzia
Location: Elénzia Redditch West Midlands
Summary
The goal of this clinical trial is to learn whether elénzia CONTROL®, a nutritional supplement, can support weight management in adults who have either never used GLP-1 weight-loss medications or have recently stopped using them. The main question it aims to answer is:
Does taking elénzia CONTROL® for 16 weeks help reduce body weight in adults who have never used GLP-1 medications or help prevent weight regain in adults who have recently stopped using them?
The study will also look at changes in appetite, sugar cravings, mood, energy, diet, sleep, physical activity, stress, quality of life, and waist circumference.
Researchers will compare elénzia CONTROL® with a placebo (a look-alike supplement that does not contain the active ingredients) to see whether elénzia CONTROL® has an effect on weight management.
Participants will:
Take two capsules of elénzia CONTROL® or placebo once a day, 30 minutes before their largest meal, for 16 weeks.
Use a mobile app to record whether they have taken their capsules and complete study questionnaires and assessments.
Measure and report their body weight and waist circumference throughout the study.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07789223). StuddyBuddy aggregates publicly available trial information.