Obesity (Disorder)NCT07304141
Pharmacological Treatment - An Overview of Its Role in Managing Childhood Obesity
An observational study of Obesity (Disorder) and Child Obesity, run by Göteborg University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity (Disorder), Child Obesity
- What is being tested?
- Liraglutide 3 mg (Saxenda)
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- 20 Dec 2023to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children at the Pediatric Clinic, Region Halland, and at the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital.
Who may be able to join
- 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
Who cannot join
- Hypothalamic obesity
- Craniopharyngioma
- Syndromic obesity / monogenic obesity
Trial locations and contacts
1 site in 1 country.
Sweden1 site
the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital.
Gothenburg, 416 50
About this study
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.
Read the 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.
- Conditions
- Obesity (Disorder), Child Obesity
- Being tested
- Liraglutide 3 mg (Saxenda)
- Keywords
- liraglutide child obesity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 3 mg (Saxenda)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| The study included adolescents aged 10-18 years with obesity who were offered liraglutide treatment | Not described Receives: Other: Liraglutide 3 mg (Saxenda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index Standard Deviation Score (BMI SDS) over time
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start20 Dec 2023
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lovisa Sjogren, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304141
- Sponsor's protocol ID
- Dnr 2023-04013-01
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment - An Overview of Its Role in Managing Childhood Obesity
- ClinicalTrials.gov ID
- NCT07304141
- Acronym / sponsor ID
- Dnr 2023-04013-01
- Conditions
- Obesity (Disorder), Child Obesity
- Keywords
- liraglutide child obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study included adolescents aged 10-18 years with obesity who were offered liraglutide treatment | – | Other: Liraglutide 3 mg (Saxenda) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children at the Pediatric Clinic, Region Halland, and at the Regional Childhood Obesity Center, Queen Silvia's Children's Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Hypothalamic obesity
- Craniopharyngioma
- Syndromic obesity / monogenic obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | The study included adolescents aged 10-18 years with obesity who were offered liraglutide treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Obesity (Disorder)
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity (Disorder) and Child Obesity, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.