Effect of GLP-1 Agonist on Weight Loss in Patients with Hypothalamic Obesity
The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study
EARLY_PHASE1 · Seoul National University Hospital · NCT06217848
This study is testing if the weight loss medication Saxenda can help people with hypothalamic obesity, which is caused by tumors in the brain, lose weight over 12 weeks.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT06217848 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of GLP-1 analogs, specifically Saxenda, in inducing weight loss among patients with hypothalamic obesity resulting from hypothalamic tumors. The study will assess various factors including eating behaviors, physical measurements, and cognitive tasks to understand the different responses to treatment based on obesity subtypes. Participants will receive escalating doses of Saxenda over a 12-week period while their activity and sleep patterns will be monitored using wearable devices. The goal is to identify the role of specific brain nuclei in the pathogenesis of hypothalamic obesity and the therapeutic efficacy of GLP-1 analogs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who have been diagnosed with a hypothalamic tumor and have experienced hypothalamic damage post-surgery.
Not a fit: Patients with severe renal or liver dysfunction, or those taking medications that may affect weight, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with hypothalamic obesity, potentially leading to significant weight loss and improved health outcomes.
How similar studies have performed: While GLP-1 analogs have been used in obesity treatment, this specific application in hypothalamic obesity is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full 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
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Sumin Lee
- Email: wendylee96@naver.com
- Phone: +82 010-6284-4379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Panhypopituitarism, Craniopharyngioma, Hypothalamic Obesity