Weight and Metabolic Management Study
WMMS
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of elénzia CONTROL® on Weight and Metabolic Health in Adults Naïve to or Who Have Recently Discontinued Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Use
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
Study Completion
Last participant's last visit for all outcomes
February 1, 2027
August 28, 2026
August 1, 2026
5 months
August 24, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage Change in Body Weight From Baseline to Week 16
Percentage change in body weight from baseline to Week 16, calculated from participant-reported body weight measured using home weighing scales. Body weight is recorded through the study app. Analyses will be conducted separately within the GLP-1-naïve and post-GLP-1 cohorts.
Baseline to Week 16
Absolute Change in Body Weight From Baseline to Week 16
Absolute change in body weight from baseline to Week 16, calculated from participant-reported body weight measured using home weighing scales and recorded through the study app. Analyses will be conducted separately within the GLP-1-naïve and post-GLP-1 cohorts.
Baseline to Week 16
Secondary Outcomes (10)
Change in Overall Appetite Score Assessed Using a Digital Visual Analogue Scale (VAS)
Baseline and every 2 weeks through Week 16
Change in Sugar Cravings Assessed Using a Digital Visual Analogue Scale (VAS)
Baseline and every 2 weeks through Week 16
Change in Overall Mood Assessed Using a Digital Visual Analogue Scale (VAS)
Baseline and every 2 weeks through Week 16
Change in Energy Levels Assessed Using a Digital Visual Analogue Scale (VAS)
Baseline and every 2 weeks through Week 16
Change in Waist Circumference From Baseline Over 16 Weeks
Baseline and every 2 weeks through Week 16
- +5 more secondary outcomes
Study Arms (4)
GLP-1-Naïve - elénzia CONTROL®
EXPERIMENTALParticipants who have never used GLP-1 receptor agonists will receive elénzia CONTROL® for 16 weeks.
GLP-1-Naïve - Placebo
PLACEBO COMPARATORParticipants who have never used GLP-1 receptor agonists will receive placebo for 16 weeks.
Post-GLP-1 - elénzia CONTROL®
EXPERIMENTALParticipants who have recently discontinued GLP-1 receptor agonist therapy will receive elénzia CONTROL® for 16 weeks.
Post-GLP-1 - Placebo
PLACEBO COMPARATORParticipants who have recently discontinued GLP-1 receptor agonist therapy will receive placebo for 16 weeks.
Interventions
elénzia CONTROL® is a commercially available multi-ingredient dietary supplement containing Eriomin® (lemon flavonoids including eriocitrin), bitter melon extract (10:1), SILIPHOS® (silybin-phosphatidylcholine complex), choline bitartrate, chromium picolinate, zinc bisglycinate chelate, iodine, and selenium. The formulation used in the study is identical to the commercially available product but is repackaged into white opaque capsules with study-specific labelling to maintain blinding. Participants will take two capsules orally once daily, 30 minutes before their largest meal, for 16 weeks.
The placebo consists of microcrystalline cellulose (MCC), gluten-free rice bran, Nu-FLOW® (rice-derived silica), and E150a food-grade caramel colour. It is encapsulated in white opaque capsules that are visually identical in colour, size, and shape to the active supplement and packaged with study-specific labelling to maintain blinding. Participants will take two capsules orally once daily, 30 minutes before their largest meal, for 16 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elenzialead
Study Sites (1)
Elénzia
Redditch, West Midlands, B98 9PA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Godsfavour Oghifo, BPharm, MSc
elénzia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Data analysts are also masked to treatment allocation. Treatment groups are identified using blinded group codes, with the randomisation key held securely by the sponsor. Treatment allocation is not revealed until completion of the primary and secondary analyses.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2026
First Posted
August 27, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Data and supporting information may be made available following completion of the trial and publication or dissemination of the main study results. The timing and duration of availability will be determined in accordance with sponsor policies and any applicable ethical, legal, or data protection requirements.
- Access Criteria
- Access to anonymised participant-level data and supporting information will be determined by the study sponsor. Where applicable, access may be provided to researchers for legitimate scientific purposes, subject to review of the request, applicable ethical and data protection requirements, and completion of any required data-sharing agreement. Only anonymised data necessary for the approved purpose will be provided.
An anonymised individual participant data (IPD) dataset underlying the reported study results may be made available, where possible, following completion of the trial. Shared data will not contain information that directly identifies individual participants. Data sharing will be subject to sponsor policies, applicable data protection requirements, ethical considerations, and any necessary data-sharing agreements.