Obesity Trial, Recruiting NCT06321458 Sponsor: Carsten Dirksen Condition: Obesity
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Obesity Trial, Recruiting

NCT06321458
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are aged between 18 and 60 years old at the time of screening
  • People who have severe and complex obesity, meaning a BMI over 35 (or over 32.5 for people with South Asian, Chinese, other Asian, Middle Eastern, Black African, or African-Caribbean heritage), along with at least one related health condition such as heart disease, type 2 diabetes, high blood pressure, fatty liver disease, or sleep apnoea
  • People who are able to give their informed consent to take part
  • Please note: participants must be invited by the trial site in order to take part

Who may not be able to join:

  • People who are pregnant, breastfeeding, or planning to become pregnant in the next two years
  • People who have used weight loss medication or a GLP-1 medication (a type of drug used for weight management or diabetes) in the last three months
  • People currently receiving treatment for cancer, unless that treatment is an oestrogen-blocking therapy or treatment for a common type of skin cancer (non-melanoma skin cancer)
  • People who have previously had certain types of weight loss (bariatric) surgery — some specific procedures may be considered on a case-by-case basis if the device was removed more than one year before screening (confirm with trial site)
  • People who have been diagnosed with or treated for a severe eating disorder in the last six months
  • People with other serious health conditions that would make it difficult to follow the treatment programme, attend follow-up appointments, or where weight loss is unlikely to improve their health or life expectancy
  • People with certain health conditions that make a total diet replacement programme unsuitable, such as type 1 diabetes, diabetes managed with insulin, phenylketonuria, or other conditions requiring a special diet
  • People with certain health conditions that make GLP-1 medications unsuitable, such as a history of pancreatitis (inflammation of the pancreas)
  • People already taking part in other research that involves a full obesity treatment programme, where doing so would interfere with this trial
  • People whose household already has another member enrolled in this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Carsten Dirksen, Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Phone: +45 29425320

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Carsten Dirksen
Registry
ClinicalTrials.gov
Start date
29 April 2024
Est. completion
1 March 2028

Where this trial is recruiting

🇩🇰 Denmark 🇬🇧 United Kingdom

Primary endpoints

MetS-Z; Weight

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov