ObesityLightWAYNCT06321458
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
A study testing Intensive weight loss intervention in people with Obesity, run by Carsten Dirksen at 14 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intensive weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 29 Apr 2024to Dec 2048
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years and ≤60 years old at screening.
- 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.
- Provides informed consent.
Who cannot join
- Intending to become pregnant in the next two years or pregnant or breastfeeding.
- Use of WLM or GLP-1 agonist treatment within the last three months.
- Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
- 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.
- Diagnosis of or treatment for severe eating disorder within the last 6 months.
- 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.
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- Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
- Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
- Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
- Another member of the household enrolled in the trial.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United Kingdom9 sites
Cwm Taf Morgannwg University Health Board
Abercynon
University Hospitals Birmingham NHS Foundation Trust
Birmingham
University Hospitals of Derby and Burton NHS Foundation Trust
Derby
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
Leeds
South West Peninsula RRDN
Plymouth
Powys Teaching Health Board
Powys
South Central RRDN
Southampton
Torbay and South Devon NHS Trust
Torquay
Royal Wolverhampton NHS Trust
Wolverhampton
Denmark5 sites
Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet
Frederiksberg, 2000
The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Frederiksberg, 2000
Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse
Hvidovre, 2650
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, 2650
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
Søborg, 2860
About this study
Official title: Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3
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.
Read the detailed description
In the LightWAY trial, an intensive weight loss (IWL) intervention will be compared with with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:
- Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.
- Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).
- Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.
Usual care will differ between the two countries (Denmark and the United Kingdom).
In Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.
In the United Kingdom, participants are eligible for referral into an NHS Tier 3 weight management service. These services are commissioned by integrated care boards, and can therefore differ slightly across the 42 regions within the UK. These are specialist weight management clinics that provide non-surgical, intensive medical management with a multidisciplinary approach to care. These clinics often consist of specialist doctors, nurses, dieticians and physiotherapists/exercise therapists, and include psychological support.
- Conditions
- Obesity
- Being tested
- Intensive weight loss intervention, Usual care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive weight loss interventionBehavioural
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual careBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Intensive weight loss intervention | Experimental | The intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication. The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total. Receives: Behavioral: Intensive weight loss intervention |
| Usual care | Active comparator | Denmark: usual care offered by the GP or local municipality. The UK: tier 3 weight management services. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MetS-Z
Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)
Measured: 104 weeks after randomisation
Weight
Weight (kg)
Measured: 104 weeks after randomisation
Secondary outcomes (3)
Short-Form-36, mental component score
Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)
Measured: 104 weeks after randomisation
Gait speed
4-metre gait speed (m/s)
Measured: 104 weeks after randomisation
Weight loss (20%)
Proportion of participants with weight loss ≥20%
Measured: 104 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start29 Apr 2024
- Primary completionMar 2028 (estimated)
- Study completionDec 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed. Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Dirksen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark, University of Oxford, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Carsten Dirksen, Copenhagen University Hospital, Hvidovre
- Investigators
- Carsten Dirksen, Study chair, Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321458
- Sponsor's protocol ID
- LightWAY
- Acronym
- LightWAY
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
Publications
Wane S, Aveyard P, Wielsoe S, Larsen SC, Scragg J, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bandholm T, Albury C, Overbeck G, Reventlow S, Olsen KR, Fahr P, Bojsen-Moller KN, Heitmann BL, Waldorff FB, Madsbad S, Dirksen C, Jebb SA. Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol. BMJ Open. 2026 May 20;16(5):e107240. doi: 10.1136/bmjopen-2025-107240.
PubMed 42161553
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3
- ClinicalTrials.gov ID
- NCT06321458
- Acronym / sponsor ID
- LightWAY / LightWAY
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Carsten DirksenUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark, University of Oxford, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2048 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the LightWAY trial, an intensive weight loss (IWL) intervention will be compared with with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:
- Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.
- Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).
- Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.
Usual care will differ between the two countries (Denmark and the United Kingdom).
In Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.
In the United Kingdom, participants are eligible for referral into an NHS Tier 3 weight management service. These services are commissioned by integrated care boards, and can therefore differ slightly across the 42 regions within the UK. These are specialist weight management clinics that provide non-surgical, intensive medical management with a multidisciplinary approach to care. These clinics often consist of specialist doctors, nurses, dieticians and physiotherapists/exercise therapists, and include psychological support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed. Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager.
| Arm | Type | Receives |
|---|---|---|
| Intensive weight loss intervention | Experimental | Behavioral: Intensive weight loss interventionThe intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication. The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total. |
| Usual care | Active comparator | Behavioral: Usual careDenmark: usual care offered by the GP or local municipality. The UK: tier 3 weight management services. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤60 years old at screening.
- 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.
- Provides informed consent.
Key exclusion criteria (10 listed)
- Intending to become pregnant in the next two years or pregnant or breastfeeding.
- Use of WLM or GLP-1 agonist treatment within the last three months.
- Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
- 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.
- Diagnosis of or treatment for severe eating disorder within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive weight loss interventionIntensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication. | Behavioural | Intensive weight loss intervention |
| Usual careUsual care | Behavioural | Usual care |
Primary outcome
MetS-Z
Time frame: 104 weeks after randomisation
Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)
Weight
Time frame: 104 weeks after randomisation
Weight (kg)
3 secondary outcomes
Short-Form-36, mental component score
Time frame: 104 weeks after randomisation
Gait speed
Time frame: 104 weeks after randomisation
Weight loss (20%)
Time frame: 104 weeks after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 42161553Wane S, Aveyard P, Wielsoe S, Larsen SC, Scragg J, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bandholm T, Albury C, Overbeck G, Reventlow S, Olsen KR, Fahr P, Bojsen-Moller KN, Heitmann BL, Waldorff FB, Madsbad S, Dirksen C, Jebb SA. Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol. BMJ Open. 2026 May 20;16(5):e107240. doi: 10.1136/bmjopen-2025-107240.
- LightCOM websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Dirksen study chair
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive weight loss intervention in people with Obesity, run by Carsten Dirksen at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MetS-Z (time frame: 104 weeks after randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06321458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.