Hypothalamic Obesity Clinical Trial
Official title:
Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.
The purpose of the study is to compare the change of body weight after 6 months treatment
with a lifestyle intervention + exenatide compare to the one after the same lifestyle
intervention+ placebo in adults patients suffering from a hypothalamic obesity due to
treatment of craniopharyngioma.
The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native
GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as
well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms
that mediate the effects of weight involve not only central regions like the hypothalamus and
the solitary tractus nucleus and area postrema but also peripheral regions as the
gastrointestinal tract. These extra hypothalamic effects are of particular interest in the
cases of obesity due to hypothalamic lesions.
Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to
human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight
loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell
function and systolic blood pressure, it could be an attractive treatment for both type 2
diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been
recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost
significantly more weight than did those on placebo (5.1 kg versus 1.6).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02849743 -
Intranasal Oxytocin in Hypothalamic Obesity
|
Phase 2 | |
| Recruiting |
NCT06217848 -
The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study
|
Early Phase 1 | |
| Withdrawn |
NCT05147415 -
Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
|
Phase 2 | |
| Completed |
NCT00892073 -
Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy
|
Phase 2 | |
| Not yet recruiting |
NCT06299891 -
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
|
Phase 2 | |
| Recruiting |
NCT06239116 -
A Study of RM-718 in Healthy Subjects and in Patients With HO
|
Phase 1 | |
| Completed |
NCT02664441 -
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
|
Phase 3 | |
| Completed |
NCT04725240 -
Open-Label Study of Setmelanotide in Hypothalamic Obesity
|
Phase 2 | |
| Completed |
NCT03673813 -
A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity
|
||
| Not yet recruiting |
NCT06046443 -
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
|
Phase 2 | |
| Withdrawn |
NCT03708913 -
Neuromodulation for Hypothalamic Obesity
|
N/A | |
| Completed |
NCT01061775 -
Effects of Exenatide on Hypothalamic Obesity
|
Phase 1/Phase 2 | |
| Completed |
NCT00171613 -
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
|
Phase 4 | |
| Recruiting |
NCT01783717 -
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
|
N/A | |
| Enrolling by invitation |
NCT05774756 -
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
|
Phase 3 | |
| Completed |
NCT05319301 -
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
|
N/A |