Bardet-Biedl SyndromeNCT07602803
The Effect of GLP1 Agonists on Weight Loss in BBS Cohort in the UK
An observational study of Bardet-Biedl Syndrome, run by The Queen Elizabeth Hospital at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn about the long-term effects of GLP1 agonists (weight loss jab, including Mounjaro) in patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat high body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bardet-Biedl Syndrome
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 22 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with a genetic diagnosis of BBS living in the UK under the UK National BBS Centres (Birmingham and London).
Who may be able to join
- All the adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK).
Who cannot join
- Adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK) who lost follow ups or significant missing data, or BMI<30 in patients without GLP1 agonists.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2GW
About this study
Official title: GLP1 Agonists Once Weekly for the Treatment of Obesity in Patients With Bardet-Biedl Syndrome (BBS)
The goal of this observational study is to learn about the long-term effects of GLP1 agonists (weight loss jab, including Mounjaro) in patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat high body weight. The main question:
Do GLP1 agonists effectively and safely lower body weight in patients with BBS when taken long-term, compared to patients not on these medications? The investigators look at the change (%) in weight during the observational periods.
Read the detailed description
Demographics on time zero: Age, gender, Race, Body Weight (BW), Body Mass Index (BMI), Blood Pressure (clinic, DM meds), Pulse, Lipid profiles (Chol, HDL, LDL, TG), eGFR, HBA1c, (if feasible) genetic diagnosis
Primary outcome at the end of study date : Body weight change (%)
Secondary outcome at the end of study date: change in lipid (Chol, HDL, LDL, TG), Blood Pressure, DM status
Quality assurance plan: data validation will be secured due to the electronic record. The registry process was undertaken in our closed national BBS centres quality assured by multi-disciplinary team (MDT) looked after by senior specialty nurses, who followed all the patients with GLP1 agonists monthly over the telephone.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results: The investigators followed all the missing data by contacting patients' family doctors (GP) and their records.
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Conditions
- Bardet-Biedl Syndrome
- Keywords
- GLP1 agonist, Weight Loss, Obesity
- Medical subject headings
- Bardet-Biedl Syndrome, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with diagnosis of BBS in national centre in the UK (London and Birmingham) | Intervention arm (BMI>30): patients with BBS treated with GLP1 agonists Control arm (BMI>30): patients with BBS without GLP1 agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss change (%) at the end of study date, compared to one at the time zero
Change (%) of Body weight (kg) from BW at the start date of this study and BW at the end of study date
Measured: From enrolment to the end of treatment at the end of study date up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2023
- Primary completion1 Apr 2026
- Study completion22 Apr 2026
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 Bardet-Biedl SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuki Heath, The Queen Elizabeth Hospital
- Investigators
- Jeremy Tomlinson, Professor, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602803
- Sponsor's protocol ID
- BBSGLP1
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, Age, gender, Race, BW, BMI, BP and pulse (clinic), diabetic medications, Lipid (Chol, HDL, LDL, TG), eGFR, HBA1c, genetic diagnosis
Publications
Yuki Heath, Jeremy Tomlinson, Lukas Foggensteiner
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP1 Agonists Once Weekly for the Treatment of Obesity in Patients With Bardet-Biedl Syndrome (BBS)
- ClinicalTrials.gov ID
- NCT07602803
- Acronym / sponsor ID
- BBSGLP1
- Conditions
- Bardet-Biedl Syndrome
- Keywords
- GLP1 agonist, Weight Loss, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 22 May 2026 (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.
The goal of this observational study is to learn about the long-term effects of GLP1 agonists (weight loss jab, including Mounjaro) in patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat high body weight. The main question:
Do GLP1 agonists effectively and safely lower body weight in patients with BBS when taken long-term, compared to patients not on these medications? The investigators look at the change (%) in weight during the observational periods.
Detailed description
Demographics on time zero: Age, gender, Race, Body Weight (BW), Body Mass Index (BMI), Blood Pressure (clinic, DM meds), Pulse, Lipid profiles (Chol, HDL, LDL, TG), eGFR, HBA1c, (if feasible) genetic diagnosis
Primary outcome at the end of study date : Body weight change (%)
Secondary outcome at the end of study date: change in lipid (Chol, HDL, LDL, TG), Blood Pressure, DM status
Quality assurance plan: data validation will be secured due to the electronic record. The registry process was undertaken in our closed national BBS centres quality assured by multi-disciplinary team (MDT) looked after by senior specialty nurses, who followed all the patients with GLP1 agonists monthly over the telephone.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results: The investigators followed all the missing data by contacting patients' family doctors (GP) and their records.
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with diagnosis of BBS in national centre in the UK (London and Birmingham) | – | –Intervention arm (BMI>30): patients with BBS treated with GLP1 agonists Control arm (BMI>30): patients with BBS without GLP1 agonists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with a genetic diagnosis of BBS living in the UK under the UK National BBS Centres (Birmingham and London).
Key inclusion criteria (1 listed)
- All the adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK).
Key exclusion criteria (1 listed)
- Adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK) who lost follow ups or significant missing data, or BMI<30 in patients without GLP1 agonists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight loss change (%) at the end of study date, compared to one at the time zero
Time frame: From enrolment to the end of treatment at the end of study date up to 18 months
Change (%) of Body weight (kg) from BW at the start date of this study and BW at the end of study date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publicationYuki Heath, Jeremy Tomlinson, Lukas Foggensteiner
- Individual participant dataSharing planned: Yes. The study protocol, Age, gender, Race, BW, BMI, BP and pulse (clinic), diabetic medications, Lipid (Chol, HDL, LDL, TG), eGFR, HBA1c, genetic diagnosis
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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.
Jeremy Tomlinson, Professor principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bardet-Biedl Syndrome, run by The Queen Elizabeth Hospital at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight loss change (%) at the end of study date, compared to one at the time zero (time frame: From enrolment to the end of treatment at the end of study date up to 18 months). 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 NCT07602803, 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 27 May 2026.