NCT06321458 Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
| NCT ID | NCT06321458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carsten Dirksen |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-04-29 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity.
Eligibility Criteria
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.
Contact & Investigator
Carsten Dirksen
STUDY CHAIR
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Frequently Asked Questions
Who can join the NCT06321458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321458 currently recruiting?
Yes, NCT06321458 is actively recruiting participants. Contact the research team at carsten.dirksen@regionh.dk for enrollment information.
Where is the NCT06321458 trial being conducted?
This trial is being conducted at Frederiksberg, Denmark, Frederiksberg, Denmark, Hvidovre, Denmark, Hvidovre, Denmark and 10 additional locations.
Who is sponsoring the NCT06321458 clinical trial?
NCT06321458 is sponsored by Carsten Dirksen. The principal investigator is Carsten Dirksen at Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre. The trial plans to enroll 600 participants.
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