Exploring GLP-1 Receptor Agonist Treatment for Adolescents with Antipsychotic-Related Obesity: The GOAL Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Clinical Pharmacology, Department of

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

24 Jun 2025 → ongoing

Decision date (initial)

2025-05-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To investigate the feasibility and effects of 34 weeks of GLP-1-RA treatment in addition to standard care in children and adolescents with obesity, who are in treatment with antipsychotics

Secondary objectives 1

1. To assess the sustainability and health outcomes of GLP-1-RA treatment in children and adolescents with obesity who are undergoing antipsychotic treatment, evaluated 6 months after the final administration of the study medication.

Conditions and MedDRA coding

Adipositas

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

All study-related data will be securely stored in the eCRF, while participant information will be kept in encrypted, password-protected databases. Laboratory samples, reports, data collection materials, and administrative documents will be identified using coded ID numbers to ensure confidentiality. Before transfer to external locations, all data will be anonymized. Records containing names or personal identifiers, such as locator and consent forms, will be stored separately from coded study records. Local databases will be protected by password-secured access systems. Any documents that link participant ID numbers to identifying information, such as forms, logs, or appointment books, will be stored in a locked, restricted-access area.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥12 and ≤18 years
2. BMI SDS ≥ 1.28 which corresponds to BMI ≥ 90 percentile according to Danish Growth Charts
3. Body composition of Body Fat Percentage ≥ 95 percentile as confirmed by Bioelectrical Impedance Analysis (BIA)
4. Minimum of four weeks of stable condition under ongoing antipsychotic treatment. Flexible dose adjustment during the trial according to clinical need is allowed
5. Verbal informed consent and assent from trial participants and oral and written informed consent from the custody holder/s and trial participants ≥ 15 years of age
6. Verbal informed consent from female participants to use contraceptive methods throughout the trial

Exclusion criteria 11

1. GLP-1-RA treatment within 35 days before baselinea
2. Any condition that the investigator judge would interfere with trial participation.
3. Previously known allergic reactions to active ingredients in Wegovy.
4. Inability to communicate in Danish.
5. Compulsory treatment (i.e., use of coercive measures)
6. Pregnancy
7. Known acute or chronic liver disease
8. Known acute or chronic kidney disease
9. Known acute or chronic pancreatic disease
10. Known type 1 diabetes and/or treatment with insulin.
11. Treatment with systemic corticosteroids or other hormone therapy (except from contraception)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of subjects completing the study from baseline to end-of-treatment

Secondary endpoints 11

1. Body composition and bone mineral density evaluated by DXA.
2. Blood pressure and heart rate.
3. Changes in total body weight, hip and waist circumference.
4. Beta cell function evaluated by homeostatic model assessment (HOMA).
5. Measures of psychopathology: Clinical Global Impressions Scale severity scale (CGI-S).
6. Antipsychotic medications, diet and exercise recorded in a diary together with alcohol, tobacco, recreational drug, and medication use.
7. Change in blood sampling markers of Hepato-biliary biomarkers, Metabolic biomarkers, Inflammatory biomarkers, Lipid profile.
8. 6-month follow-up assessing continuation of GLP-1-RA use on participant’s own initiative.
9. MASLD evaluated by MRI proton density fat-fraction and biochemistry.
10. Change in fat percentages using bioelectrical impedance analysis
11. Body-mass index standard deviation score (BMI-SDS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Clinical Pharmacology, Department of

Sponsor organisation

Clinical Pharmacology, Department of

Address

Bispebjerg Bakke 23, Opgang 20 C, 2. sal, Bispebjerg Hospital Opgang 20 C, 2. sal Bispebjerg Hospital

City

Copenhagen NV

Postcode

2400

Country

Denmark

Scientific contact point

Organisation

Clinical Pharmacology, Department of

Contact name

Christina Gade

Public contact point

Organisation

Clinical Pharmacology, Department of

Contact name

Christina Gade

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications