The Effect of GLP1 Agonists on Weight Loss in BBS Cohort in the UK

GLP1 Agonists Once Weekly for the Treatment of Obesity in Patients With Bardet-Biedl Syndrome (BBS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07602803

Enrollment

300

Registered

2026-05-22

Start date

2023-01-01

Completion date

2026-04-22

Last updated

2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bardet-Biedl Syndrome

Keywords

GLP1 agonist, Weight Loss, Obesity

Brief 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. 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All the adult patients with a genetic diagnosis of BBS under the national BBS centres (London and Birmingham in the UK).

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Weight loss change (%) at the end of study date, compared to one at the time zero	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

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORJeremy Tomlinson, Professor

University Hospital Birmingham NHS Foundation Trust

Outcome results