NCT07602803

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 our patients with Bardet-Biedl Syndrome (BBS) who take GLP1 agonists to treat their 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? We look at the change (%) in weight during the observational periods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

GLP1 agonistweigth lossobesity

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrolment to the end of treatment at the end of study date up to 18 months

Study Arms (1)

Patients with diagnosis of BBS in our national centre in the UK (London and Birmingham)

Intervention arm: patients with BBS treated with GLP1 agonists Control arm: patients with BBS without GLP1 agonists

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients with a genetic diagnosis of BBS living in the UK under the NHS.

You may qualify if:

  • All the patients with BBS genetic diagnosis under the national BBS centres (London and Birmingham in the UK).

You may not qualify if:

  • Patients who lost the follow up or significant missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

Related Publications (1)

  • Yuki Heath, Jeremy Tomlinson, Lukas Foggensteiner

    RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy Tomlinson, Professor

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialty Doctor in Renal Medicine

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start

January 1, 2023

Primary Completion

April 1, 2026

Study Completion

April 22, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The study protocol, Age, gender, Race, BW, BMI, BP (clinic, meds?), Pulse, Lipid (Chol, HDL, LDL, TG), eGFR, HBA1c, genetic diagnosis

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Beginning right after publication with no end date
Access Criteria
a data sharing agreement must be signed, and those documents can be submitted via emails.
More information

Locations