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

NCT06217848 | Unknown Early Phase 1 DMC

• 1 other identifier: 2208-031-1348
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Panhypopituitarism; Craniopharyngioma; Hypothalamic Obesity

Outcome Measures

Primary Outcomes (1)

• Change in weight

  3 month

Study Arms (1)

Patients diagnosed with a hypothalamic tumor.

EXPERIMENTAL

Drug: Saxenda

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.

Patients diagnosed with a hypothalamic tumor.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with a hypothalamic tumor and treated surgically with confirmed hypothalamic damage
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Combined Pituitary Hormone Deficiency; Craniopharyngioma; Sexual Infantilism

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Sumin Lee

CONTACT

+82 010-6284-4379; wendylee96@naver.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 23, 2024
• Study Start: November 28, 2022
• Primary Completion: February 8, 2024
• Study Completion: March 8, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

KR (1)