Pharmacological Treatment - An Overview of Its Role in Managing Childhood Obesity

February 24, 2026 updated by: Lovisa Sjogren, Göteborg University
The aim of the study is to examine the effects of pharmacological treatment for obesity on BMI trajectories and metabolic markers among patients in routine clinical care. A retrospective observational study. By collecting and analysing real-life data from the first children and adolescents in Sweden who have been offered pharmacological treatment for obesity, the results can contribute to a better understanding of how these treatments function in practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim

The aim of this sub-study is to evaluate the impact of liraglutide treatment on the trajectory of body mass index (BMI), including BMI according to International Obesity Task Force (IOTF) criteria and BMI standard deviation score (BMI SDS), as well as its effects on cardiovascular risk markers among children and adolescents treated with liraglutide in two Swedish regions. The study seeks to generate real-world evidence on the effectiveness of liraglutide in routine clinical practice.

Study Design

This is a retrospective, observational study based on medical records of children and adolescents who received multidisciplinary obesity care for at least one year and were treated with liraglutide during 2022-2023 at either the Pediatric Clinic in Region Halland or the Regional Childhood Obesity Center at Queen Silvia's Children's Hospital. The study is non-interventional and does not introduce any additional risks beyond standard clinical care. Participation was voluntary, with informed consent obtained from legal guardians and assent from children.

Participants

Eligible participants include children and adolescents who:

Were enrolled in multidisciplinary obesity care for at least one year

Received liraglutide treatment during 2022-2023 at one of the study sites

Were invited to participate either during clinical visits or via written invitation

Data on comorbidities, including neuropsychiatric diagnoses, were also collected to assess potential confounding factors.

Data Collection

Data were extracted retrospectively from medical records and include:

Demographics: sex, age

Anthropometrics: height, weight, BMI, BMI SDS, BMI according to IOTF criteria

Treatment details: titration period, maximum tolerated dose, and treatment outcomes at 3-6, 12, 18.

Metabolic parameters: blood pressure, lipid profile, fasting glucose, and HbA1c

Comorbidities: neuropsychiatric and other relevant diagnoses

All data were anonymized and handled in accordance with Swedish data protection regulations.

Statistical Analysis

Descriptive Statistics:

Continuous variables (e.g., age, BMI, metabolic parameters) will be summarized using mean ± standard deviation (SD) or median with interquartile range (IQR), as appropriate.

Categorical variables (e.g., sex, comorbidities) will be summarized using counts and percentages.

Treatment effects at 3-6, 12, 18, and 24 months will be evaluated using appropriate repeated measures models, accounting for potential confounders such as age, sex, baseline BMI, and comorbidities.

Handling of Missing Data:

Missing data will be assessed for patterns and mechanisms.

Multiple imputation or sensitivity analyses may be performed depending on the proportion and nature of missing values.

Statistical Collaboration:

All analyses will be conducted in collaboration with an experienced statistician.

The analysis plan and results will be reviewed and validated by both the statistician and study supervisors.

Ethical Considerations

Participation was voluntary and did not affect ongoing clinical care.

Informed consent was obtained from legal guardians, with assent from children.

Data were anonymized and managed according to Swedish data protection laws.

The study was retrospective and non-interventional; no specific approval from the Swedish Medical Products Agency was required.

All procedures adhere to the ethical principles of the Declaration of Helsinki.

Dissemination

Results will be disseminated through a peer-reviewed publication and scientific conference presentations. Sub-study III is expected to be finalized in 2026.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 416 50
        • the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children at the Pediatric Clinic, Region Halland, and at the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital.

Description

Inclusion Criteria:

  • Adolescents aged 10-18 years with obesity who were offered pharmacological treatment
  • Provided consent to participate
  • Participants with short treatment duration, early adverse effects, or who proceeded to surgery are also included in baseline data

Exclusion Criteria:

  • Hypothalamic obesity
  • Craniopharyngioma
  • Syndromic obesity / monogenic obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The study included adolescents aged 10-18 years with obesity who were offered liraglutide treatment
Other: Liraglutide 3 mg (Saxenda)
This is a retrospective observational study of adolescents aged 10-18 years with obesity who were offered liraglutide treatment at the Pediatric Clinic in Region Halland and at the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital, Sahlgrenska University Hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Body Mass Index Standard Deviation Score (BMI SDS) over time
Time Frame: The primary outcome, change in BMI SDS, will be evaluated at -12 months (pre-baseline), at baseline (0 months), and at +3-6, +12, and +18 months following treatment initiation.
The primary outcome, change in BMI SDS, will be evaluated at -12 months (pre-baseline), at baseline (0 months), and at +3-6, +12, and +18 months following treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2023-04013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers. This decision is based on ethical and legal considerations, as the dataset includes sensitive health information from children and adolescents. According to Swedish data protection regulations and the conditions of the ethical approval, IPD cannot be shared outside the research team. Only aggregated, anonymized results will be made available through scientific publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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