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

January 11, 2024 updated by: Jung Hee Kim, Seoul National University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients diagnosed with a hypothalamic tumor.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Estimated)

February 8, 2024

Study Completion (Estimated)

March 8, 2024

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2208-031-1348

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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