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

Sponsor
Seoul National University Hospital
Study ID
NCT06217848
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Craniopharyngioma
  • Hypothalamic Obesity
  • Panhypopituitarism

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saxenda — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 28, 2022
Status verified
Jan 2024
Primary completion
Feb 8, 2024
Completion
Mar 8, 2024

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients diagnosed with a hypothalamic tumor.

Primary Outcome Measure

Change in weight [ Time Frame: 3 month ]

Central Contacts

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