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Intensive weight loss program aims to transform care for severe obesity

NCT ID NCT06321458

Disease control Sponsor: Carsten Dirksen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study compares an intensive weight loss program—including meal replacements, behavioral support, and weight-loss medication—against standard care for adults with severe and complex obesity. The goal is to see if the intensive approach leads to better health outcomes and is cost-effective. 600 participants aged 18-60 with a BMI over 35 (or slightly lower for certain ethnic groups) and related health issues like heart disease or diabetes are being recruited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

605 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2048

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Please note that participants need to be invited in order to take part in the trial Inclusion Criteria: 1. Age ≥18 years and ≤60 years old at screening. 2. Has severe and complex obesity i.e. BMI\>35 or \>32.5 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds and with one or more of these specific adiposity-related chronic diseases of cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea. 3. Provides informed consent. Exclusion Criteria: 1. Intending to become pregnant in the next two years or pregnant or breastfeeding. 2. Use of WLM or GLP-1 agonist treatment within the last three months. 3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer. 4. Prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \>1 year before screening. 5. Diagnosis of or treatment for severe eating disorder within the last 6 months. 6. Any other disease that markedly compromises the participant's ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person's length or quality of life, such as conditions limiting life expectancy. 7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets). 8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis) 9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial. 10. Another member of the household enrolled in the trial.

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Cwm Taf Morgannwg University Health Board

    Abercynon, United Kingdom

  • Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

    Frederiksberg, 2000, Denmark

  • Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

    Søborg, 2860, Denmark

  • Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse

    Hvidovre, 2650, Denmark

  • Powys Teaching Health Board

    Powys, United Kingdom

  • Royal Wolverhampton NHS Trust

    Wolverhampton, United Kingdom

  • South Central RRDN

    Southampton, United Kingdom

  • South West Peninsula RRDN

    Plymouth, United Kingdom

  • The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre

    Hvidovre, 2650, Denmark

  • The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

    Frederiksberg, 2000, Denmark

  • Torbay and South Devon NHS Trust

    Torquay, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, United Kingdom

  • University Hospitals of Derby and Burton NHS Foundation Trust

    Derby, United Kingdom

  • Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)

    Leeds, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.