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RecruitingNCT06217848Updated Jan 23, 2024

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

An Early Phase 1 interventional study of Saxenda in Panhypopituitarism, Craniopharyngioma and Hypothalamic Obesity, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Seoul National University Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2022, registered Dec 2023).
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Panhypopituitarism
  • Craniopharyngioma
  • Hypothalamic Obesity
03

In context

Craniopharyngioma

65 studies on the registry are indexed under Craniopharyngioma; 21 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 45 interventional studies indexed under Craniopharyngioma.

Browse Craniopharyngioma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients diagnosed with a hypothalamic tumor.

    Drug: Saxenda

Interventions

  • DrugSaxenda

    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.

06

What researchers measure

Primary outcomes

  1. Change in weight

    Time frame: 3 month

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Jongno-gu 03080, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06217848
Lead sponsor
Seoul National University Hospital
Responsible party
Jung Hee Kim (associate professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 23, 2024
Start date
Nov 28, 2022
Primary completion
Feb 8, 2024 (estimated)
Completion
Mar 8, 2024 (estimated)
Last update
Jan 23, 2024

Study contacts

Sumin Lee
Contact
wendylee96@naver.com
+82 010-6284-4379

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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