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

NCT ID: NCT06217848

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2024-03-08

Brief 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.

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.

Conditions

Panhypopituitarism; Craniopharyngioma; Hypothalamic Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with a hypothalamic tumor.

Group Type: EXPERIMENTAL

Saxenda

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung Hee Kim

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sumin Lee

Role: CONTACT

wendylee96@naver.com

+82 010-6284-4379

Facility Contacts

Sumin Lee

Role: primary

wendylee96@naver.com

+821062844379

Other Identifiers

2208-031-1348

Identifier Type: -

Identifier Source: org_study_id