ClinicalTrials.gg
RecruitingNCT07789223WMMSUpdated Sep 17, 2026

Weight and Metabolic Management Study

An interventional study of elénzia CONTROL® and Placebo in Overweight, Obesity and Weight Maintenance, sponsored by Elenzia. Recruiting at 1 site in United Kingdom. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Elenzia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 452 studies in Obesity with a site in United Kingdom — 92 open to participants now, 126 under way, 39 of them phase 3. Obesity · United Kingdom.

Planned enrollment
113th of 370
200 · median 65
Started
2026
with 43 others
No phase
225 of 452
38 open now
Primary completion
2027-02
later than 44 of 125 live
Registered
444th of 452
by date

Among the 452 studies in Obesity with a site in United Kingdom, this one is the 113th largest by planned enrollment of the 370 interventional ones that give a count, is one of 44 that started in 2026, is one of 225 with no phase, reaches primary completion later than 44 of the 125 other live ones, and was the 444th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

92 of the 452 studies in Obesity with a site in United Kingdom are open now. Recruiting first, the newest first:

86 more — sign in →

All 92 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 25 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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.

Read the detailed description

This study will evaluate elénzia CONTROL®, a multi-ingredient nutritional supplement, in adults who are managing their weight either without previous use of glucagon-like peptide-1 (GLP-1) receptor agonists or following recent discontinuation of GLP-1 therapy.

GLP-1 receptor agonists are increasingly used for weight management; however, weight regain following discontinuation is common. Although nutritional and lifestyle support is recommended as part of ongoing weight management, evidence remains limited on specific nutritional strategies for supporting weight maintenance following discontinuation of GLP-1 therapy. For adults who have not previously used GLP-1 medications, nutritional approaches targeting physiological pathways involved in appetite regulation and metabolic function may also offer a means of supporting weight management. The study therefore includes two distinct populations: adults who have never used GLP-1 receptor agonists and adults who have recently discontinued GLP-1 therapy. These populations will be evaluated separately to account for their different weight-management contexts and expected responses.

elénzia CONTROL® combines nutritional ingredients selected to target multiple physiological pathways relevant to weight and metabolic health, including pathways involved in appetite regulation, glucose and lipid metabolism, hepatic metabolic function, and thyroid hormone synthesis. Individual components of the formulation have previously been investigated in human studies; however, the complete elénzia CONTROL® formulation has not previously been evaluated in a controlled clinical trial. This study therefore represents the first formal clinical evaluation of the combined formulation in these populations.

The primary aim is to determine the effect of elénzia CONTROL® supplementation on body weight over 16 weeks. In participants who have never used GLP-1 receptor agonists, the study will investigate whether supplementation supports weight reduction. In participants who have recently discontinued GLP-1 therapy, it will investigate whether supplementation helps prevent weight regain following discontinuation.

The study will also examine broader changes that may be relevant to weight management and participants' overall experience. These include appetite, sugar cravings, mood, energy, dietary intake, sleep, physical activity, stress, weight-related quality of life, and waist circumference. Together, these measures are intended to provide a broader understanding of changes occurring during the study alongside changes in body weight.

The study will be conducted remotely, allowing participants to take part from their usual home environment. Study activities will be managed digitally through a mobile application, including informed consent, study questionnaires, self-reported measurements, supplement-use recording, and ongoing study monitoring. This decentralised approach is intended to evaluate the intervention under conditions that reflect its intended real-world use while maintaining the methodological features of a randomised, double-blind, placebo-controlled clinical trial.

03

Conditions studied

  • Overweight
  • Obesity
  • Weight Maintenance

Browse trials for

Keywords

  • Weight Management
  • Weight Loss
  • Weight Regain
  • GLP-1 Receptor Agonists
  • GLP-1 Discontinuation
  • Appetite Regulation
  • Metabolic Health
  • Nutritional Supplement
  • Nutraceutical
  • Decentralized Clinical Trial
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 200 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

This is the only study on the registry with Elenzia as lead sponsor.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • (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 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

Exclusion Criteria:

  • Previous or current use of elénzia CONTROL®.
  • Current smoking or use of nicotine-containing products.
  • Pregnancy or breastfeeding.
  • Known 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 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 , 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    GLP-1-Naïve - elénzia CONTROL®

    Participants who have never used GLP-1 receptor agonists will receive elénzia CONTROL® for 16 weeks.

    Dietary Supplement: elénzia CONTROL®

  • Placebo comparator
    GLP-1-Naïve - Placebo

    Participants who have never used GLP-1 receptor agonists will receive placebo for 16 weeks.

    Dietary Supplement: Placebo

  • Experimental
    Post-GLP-1 - elénzia CONTROL®

    Participants who have recently discontinued GLP-1 receptor agonist therapy will receive elénzia CONTROL® for 16 weeks.

    Dietary Supplement: elénzia CONTROL®

  • Placebo comparator
    Post-GLP-1 - Placebo

    Participants who have recently discontinued GLP-1 receptor agonist therapy will receive placebo for 16 weeks.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementelénzia CONTROL®

    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.

  • Dietary supplementPlacebo

    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.

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to Week 16

  2. 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.

    Time frame: Baseline to Week 16

Secondary outcomes

  1. Change in Overall Appetite Score Assessed Using a Digital Visual Analogue Scale (VAS)

    Appetite over the previous week is assessed through the study mobile app using four digital Visual Analogue Scale (VAS) items measuring hunger, fullness, satisfaction, and prospective food consumption. Each item is scored from 0 to 100 using a percentage-based slider. Hunger and prospective food consumption are reverse-scored, and the overall appetite score is calculated as the mean of the four items: \[satisfaction + fullness + (100 - hunger) + (100 - prospective food consumption)\] / 4. The overall score ranges from 0 to 100, with higher scores indicating greater satiety/lower appetite and lower scores indicating greater appetite.

    Time frame: Baseline and every 2 weeks through Week 16

  2. Change in Sugar Cravings Assessed Using a Digital Visual Analogue Scale (VAS)

    Sugar cravings over the previous week are assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate the strength of their craving for sugary foods using a percentage-based slider ranging from 0 (No craving) to 100 (Extreme craving). Higher scores indicate stronger sugar cravings. Change from baseline will be evaluated over the 16-week study period.

    Time frame: Baseline and every 2 weeks through Week 16

  3. Change in Overall Mood Assessed Using a Digital Visual Analogue Scale (VAS)

    Overall mood over the previous week is assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate their overall mood using a percentage-based slider ranging from 0 (Very low) to 100 (Excellent mood). Higher scores indicate better overall mood. Change from baseline will be evaluated over the 16-week study period.

    Time frame: Baseline and every 2 weeks through Week 16

  4. Change in Energy Levels Assessed Using a Digital Visual Analogue Scale (VAS)

    Perceived energy levels over the previous week are assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate their energy levels using a percentage-based slider ranging from 0 (Very low) to 100 (Very high). Higher scores indicate higher perceived energy levels. Change from baseline will be evaluated over the 16-week study period.

    Time frame: Baseline and every 2 weeks through Week 16

  5. Change in Waist Circumference From Baseline Over 16 Weeks

    Change in self-measured waist circumference from baseline. Participants measure their waist circumference using the measuring tape provided for the study and record the measurement through the study app. A negative change indicates a reduction in waist circumference and a positive change indicates an increase.

    Time frame: Baseline and every 2 weeks through Week 16

  6. Change in Dietary Intake Assessed Using a Short Food Frequency Questionnaire (FFQ)

    Dietary intake over the previous month is assessed through the study mobile app using an 8-item Short Food Frequency Questionnaire (FFQ). Participants report the frequency of consumption of: fruit, vegetables or salads; wholegrain foods; oily fish; red or processed meat; sweets, chocolate, sugary drinks or desserts; dairy products; pastries, crisps or butter/spreads; and alcohol. Each item has five ordered response categories: Never, Rarely (1-2 times/week), Sometimes (3-4 times/week), Often (5-6 times/week), and Daily. Dietary items will be evaluated individually for changes in reported consumption frequency over time; no overall composite score is calculated. The direction of interpretation depends on the individual food category.

    Time frame: Baseline, Week 8 and Week 16

  7. Change in Sleep Quality Assessed Using a Short Sleep Quality Questionnaire

    Sleep over the previous month is assessed through the study mobile app using a 4-item questionnaire adapted from selected domains of the Pittsburgh Sleep Quality Index (PSQI), covering overall sleep quality, average nightly sleep duration, difficulty falling asleep, and waking during the night or too early. Overall sleep quality is rated using four ordered categories from Very good to Very bad. Average sleep duration is reported numerically from 0 to 12 hours per night. Difficulty falling asleep and night/early waking are each rated using four frequency categories: Never, 1-2 nights/week, 3-4 nights/week, and 5-7 nights/week. Each sleep measure will be evaluated individually for changes over time; no overall composite sleep score is calculated. For overall sleep quality and sleep-disturbance frequency, worse or more frequent responses indicate poorer sleep; sleep duration is interpreted separately as hours of sleep per night.

    Time frame: Baseline, Week 8 and Week 16

  8. Change in Physical Activity Assessed Using a Short Physical Activity Questionnaire

    Physical activity over the previous month is assessed through the study mobile app using a short questionnaire adapted from the International Physical Activity Questionnaire (IPAQ) framework. Participants report vigorous activity, moderate activity and walking lasting at least 10 minutes at a time. For each activity type, frequency is reported as No activity, 1-4 days, 5-12 days, or more than 12 days in the past month, and usual duration on active days is reported in hours and minutes. Average weekday sitting time is reported separately in hours and minutes. Activity frequency and duration will be used to provide a study-specific estimate of physical activity and will be evaluated separately for vigorous activity, moderate activity and walking; sitting time will be evaluated separately as an indicator of sedentary behaviour. Higher activity frequency and/or duration indicates greater reported physical activity, while higher sitting time indicates greater sedentary behaviour.

    Time frame: Baseline, Week 8 and Week 16

  9. Change in Perceived Stress Assessed Using the Perceived Stress Scale-4 (PSS-4)

    Perceived stress over the previous month is assessed through the study mobile app using the 4-item Perceived Stress Scale (PSS-4). Each item is scored on a 5-point scale from 0 (Never) to 4 (Very often). The two positively worded items are reverse scored, and the four item scores are summed to produce a total score ranging from 0 to 16. Higher total scores indicate greater perceived stress, while lower scores indicate lower perceived stress. Change in total PSS-4 score from baseline will be evaluated over the 16-week study period.

    Time frame: Baseline, Week 8 and Week 16

  10. Change in Weight-Related Quality of Life Assessed Using a 12-Item Questionnaire

    Weight-related quality of life over the previous month is assessed through the study mobile app using a 12-item questionnaire adapted from domains of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT). The questionnaire covers physical function (5 items), psychosocial/self-esteem (4 items), and social/public distress (3 items). Each item is rated using five response categories: Never, Rarely, Sometimes, Often, and Daily, scored from 0 to 4, respectively. Item scores are summed to produce a total score ranging from 0 to 48. Higher scores indicate greater weight-related impairment and therefore poorer weight-related quality of life; lower scores indicate less impairment and better weight-related quality of life. Change in total score from baseline will be evaluated over the 16-week study period.

    Time frame: Baseline and Week 16

08

Study locations

1 of 1 sites recruiting
  • Elénzia
    Redditch, West Midlands B98 9PA, United Kingdom
    Recruiting
    • Godsfavour Oghifo, BPharm, MSc · Contactgodsfavour@elenzia.com · +44 7483 543042
    • Alexander Pilawski, BSc · Contactalexander@elenzia.com · +44 7948 352008
    • Godsfavour Oghifo, BPharm, MSc · Principal investigator
09

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Clinical study report

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.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.

Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 5 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Sep 15, 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07789223
Lead sponsor
Elenzia
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 15, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Godsfavour Oghifo
Contact
godsfavour@elenzia.com
+44 7483 543042
Alexander Pilawski
Contact
alexander@elenzia.com
+44 7948352008
Godsfavour Oghifo, BPharm, MSc
principal investigator · elénzia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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