The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study

Study Purpose

GLP-1 analogs are used as agents in the existing treatment of obesity. However, there are lack of previous reports on the effectiveness and role of GLP-1 analogs in the development of obesity traits in patients with functionally impaired hypothalamus. With this preliminary study, the investigators would explore the role of GLP-1 analogues to identify eating behavioral pathology subtype differences in the therapeutic efficacy of GLP-1 analogues in hypothalamic obesity patients. This will allow us to identify the role of specific nuclei which could be the pathogenesis of hypothalamic obesity. Our hypotheses: GLP-1 analogs will effectively induce weight loss in patients with hypothalamic obesity, and different subtypes of hypothalamic obesity will respond differently to GLP-1 analogs.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients diagnosed with a hypothalamic tumor and treated surgically with confirmed hypothalamic damage.
  • - 19 years of age or older.
  • - Have a body mass index of at least 27 and less than 30 (27≤BMI<30) and one or more confirmed weight-related medical conditions, or a body mass index of 30 or greater (BMI≥30).
  • - Voluntarily agreed to participate in the study after receiving a full explanation of the study.

Exclusion Criteria:

  • - Unable to fully understand the instructions for participation in the study or unable to give voluntary consent.
  • - Presence or history of a medical condition or disease that, in the opinion of the investigator, would make it difficult for the patient to participate fully for the duration of the study or to interpret the results of the study.
  • - Taking medications that may affect weight, except for hormone replacement therapy, in the last 6 months.
  • - non-primary tumor patient.
- Diagnosis of severe renal dysfunction, liver dysfunction, or thyroid disease among other underlying conditions

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06217848
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Seoul National University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Panhypopituitarism, Craniopharyngioma, Hypothalamic Obesity
Additional Details

Study Overview.

  • - Collecting baseline clinical information, comorbidities, pituitary hormone status assessment, and treatment options, including supplemental therapies and surgery.
  • - Assessment of factors associated with obesity through physical measurements, questionnaires, and cognitive-behavioral tasks, and division of patients by eating behavior subtypes for further analysis.
  • - Collecting patients' meal records and meal times by self-reporting.
  • - Collecting data on patients' activity and sleep patterns through wearable devices.
  • - Patients will receive subcutaneous injections of Saxenda 18 mg/3 mL Pen (liraglutide_obesity) starting at 0.6 mg qd.
Increase by 0.6 mg qd at weekly intervals to 1.2 mg qd in week 2, 1.8 mg qd in week 3, 2.4 mg qd in week 4, 3.0 mg qd in week 5, and maintain for 8 weeks at a maximally tolerated dose within 3.0 mg starting in week 5. If the subject's response to treatment does not allow for escalation to the planned dose, subjects will inject an adaptive maximally tolerated dose within the planned dose at each cycle. Total duration of Saxenda treatment is 12 weeks. Eating behavior assessment questionnaires and cognitive behavioral tasks will be completed before the first dose, before the end of the dose escalation period, and after the final dose to explore treatment response. Study Eligibility.
  • - Patients aged 19 years and older who were diagnosed with a hypothalamic tumor and surgically treated at Seoul National University Hospital, and who met the inclusion and exclusion criteria after receiving a full explanation of the study and voluntary consent.

Arms & Interventions

Arms

Experimental: Patients diagnosed with a hypothalamic tumor.

Interventions

Drug: - Saxenda

Patients will receive subcutaneous injections of Saxenda 18 mg/3 mL Pen (liraglutide_obesity) starting at 0.6 mg qd. Increase by 0.6 mg qd at weekly intervals to 1.2 mg qd in week 2, 1.8 mg qd in week 3, 2.4 mg qd in week 4, 3.0 mg qd in week 5, and maintain for 8 weeks at a maximally tolerated dose within 3.0 mg starting in week 5. If the subject's response to treatment does not allow for escalation to the planned dose, subjects will inject an adaptive maximally tolerated dose within the planned dose at each cycle. Total duration of Saxenda treatment is 12 weeks.

Contact a Trial Team

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International Sites

Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, Jongno-gu, 03080

Site Contact

Sumin Lee

[email protected]

+821062844379

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