NCT07702825

Brief Summary

The goal of this study is to quantify the body composition and organ fat distribution changes with obesity interventions in adolescents with severe obesity. The main question the investigators aim to answer is if there is improvement in organ health with weight loss intervention. The investigators will be comparing the degree of these changes between children being treated with GLP1 receptor agonists in addition to lifestyle changes and those managed with lifestyle changes alone. Participants will undergo MRI body composition at baseline and after 9 months.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress24%
Mar 2026Jan 2028

Study Start

First participant enrolled

March 6, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 1, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

ObesityGLP1 receptor agonistMRI Body composition

Outcome Measures

Primary Outcomes (1)

  • Change in Liver fat measured using quantitative MRI

    Change in liver fat content from baseline to follow-up, quantified using MRI-derived proton density fat fraction (PDFF).

    From enrollment to 9 months

Secondary Outcomes (4)

  • Changes to body composition assessed by MRI

    Baseline to 9 months

  • Change in pancreatic fat assessed by MRI.

    Baseline to 9 months

  • Changes in biochemical parameters-fasting glucose

    9 months

  • Changes in biochemical parameters-HbA1C

    9 months

Other Outcomes (1)

  • Change in sleep study parameter

    9 months

Study Arms (2)

Patients on GLP1 receptor agonist

Patients being treated with GLP1 receptor agonist in addition to lifestyle interventions

Patients not on GLP1 receptor agonist

Patients not being treated with GLP1 receptor agonist and only on lifestyle intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Eligible adolescents under the care of the tertiary weight management service (Complications from Excess Weight service) at Alder Hey Children's hospital will be offered to enrol in the study once a decision has been taken whether or not they are being started on GLP1 receptor agonist treatment.

You may qualify if:

  • Age 12 to \<18 years at the time of enrolment
  • BMI \>99.6th centile or \>2.67 SDS
  • Informed consent from parent(s) (or person with parental responsibility) and assent from the child or young person for participants aged less than 16 years (or)
  • Informed consent from the participant if aged ≥ 16 years.

You may not qualify if:

  • Body weight above upper limit of the scanner (\>250 kilograms)
  • Needs general anaesthesia for the MRI scanning
  • Any contraindications for MRI- Metal implants/claustrophobia
  • Previous use of GLP-1 receptor agonist
  • Refusal to consent or refusal to assent from a competent older adolescent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alder Hey Children's hospital

Liverpool, Merseyside, L122AP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anand Ramakrishnan, MD (Ped), MSc (Diab), PhD endo

CONTACT

Anand Ramakrishnan, MBBS, MD, MRCPCH, DipUKMP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start

March 6, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations