Clinical trials: Hypothalamic Obesity
Metabolic Syndrome, Hypersecretion; Cortisol
Effects of IL-1 Beta on the HPA-axis in Obese Persons
In obese individuals cortisol production and secretion is increased but the underlying mechanism is not known. Obesity leads to a pathological activation of the innate immune system partly driven by tissue production of IL-1β.
- Trial name
- CortIL (NCT02227420)
- Testing
- Anakinra
- Where
- Switzerland
- Volunteers
- 76 people
- Sponsor
- University Hospital, Basel, Switzerland
Bardet Biedl Syndrome (BBS), Alström Syndrome (AS)
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity
This pivotal, phase 3 study is designed to confirm the efficacy and safety of setmelanotide, a potent melanocortin receptor type 4 (MC4R) agonist, for the treatment of obesity and hyperphagia in participants with Bardet Biedl…
- Trial name
- NCT03746522
- Testing
- Setmelanotide
- Where
- 12 sites in United States, Canada and 4 more
- Volunteers
- 52 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with…
- Conditions
- Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia
- Trial name
- NCT06760546
- Testing
- Setmelanotide
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Adrenal Insufficiency, Pituitary Neoplasm
Evaluation of Patients With Endocrine-Related Conditions
This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology.
- Conditions
- Adrenal Insufficiency, Pituitary Neoplasm, Obesity
- Trial name
- NCT00005664
- Where
- United States
- Volunteers
- 1,588 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteogenesis Imperfecta, Osteoporosis
REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free…
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Hypogonadisms, Neoplasia
- Trial name
- NCT07412782
- Testing
- REMS
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Meyer Children's Hospital IRCCS
Endocrine Disorders, Adiposity
Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary…
- Conditions
- Endocrine Disorders, Adiposity, Pituitary Adenoma, Cushing Syndrome
- Trial name
- NCT06326853
- Volunteers
- 200 people
- Sponsor
- IRCCS San Raffaele
Hypogonadism, Metabolic Syndrome X
Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome
Obesity and the metabolic syndrome in men are associated with a high prevalence of hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines and pro-inflammatory cytokines such as IL-1-beta, IL-6…
- Conditions
- Hypogonadism, Metabolic Syndrome X, Obesity
- Trial name
- TestIL (NCT02672592)
- Testing
- Anakinra, Sodium Chloride 0.9%
- Where
- 2 sites in Switzerland
- Volunteers
- 70 people
- Sponsor
- University Hospital, Basel, Switzerland
Obesity, Infant
Determine if Human Infant Weight Gain Can be Modulated to Prevent Obesity
The global obesity epidemic has extended to low and middle income countries (LMICs) in which in a dramatic nutritional transition has shifted from maternal/child undernutrition to overnutrition.
- Trial name
- NCT04526860
- Testing
- Calibration of infant breast milk and formula milk intake
- Where
- Brazil
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Hypothalamic Obesity
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic parameters in a double-blind…
- Trial name
- ECHO (NCT02664441)
- Testing
- Exenatide
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- Seattle Children's Hospital
Craniopharyngioma, Obesity
Prospective Study of Children and Adolescents With Craniopharyngioma
The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality…
- Trial name
- NCT01272622
- Testing
- Radiation, wait and watch
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Klinikum Oldenburg gGmbH
Obesity Associated With Defects in Leptin-melanocortin Pathway
Open-Label Extension Study of Setmelanotide
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous…
- Trial name
- NCT06596135
- Testing
- Setmelanotide
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Obesity
Deep Brain Stimulation Effects in Patients With Chronic Refractory Obesity
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) as a treatment for chronic refractory obesity.
- Trial name
- NCT04453020
- Testing
- DBS of the LHA
- Where
- United States
- Sponsor
- donald whiting
Hypothalamic Obesity
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).
- Trial name
- NCT04725240
- Testing
- Setmelanotide
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Bardet Biedl Syndrome (BBS), Bardet Biedl Syndrome
Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
Bardet-Biedl syndrome (BBS) and other rare disorders associated with impairment of the melanocortin-4 receptor (MC4R) pathway are characterized by severe early-onset obesity, hyperphagia, and substantial morbidity.
- Conditions
- Bardet Biedl Syndrome (BBS), Bardet Biedl Syndrome, Bardet-Biedl Syndrome (BBS), Alstrom Syndrome
- Trial name
- REAL-MC4 (NCT07674290)
- Testing
- Setmelanotide
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Tom Hühne
Obesity, Prader Willi Syndrome
Macronutrient Regulation of Ghrelin and Peptide YY
The hyperghrelinemia of children with PWS provides a unique model by which to explore the hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions.
- Trial name
- NCT02464514
- Testing
- High carbohydrate meal, High fat meal
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Obesity, Short Stature
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
Background: Overweight and obese children and adults often have lower levels of growth hormone in the blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood.
- Conditions
- Obesity, Short Stature, Growth Hormone Deficiency
- Trial name
- NCT01237041
- Testing
- Niacin First, Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Obesity, Growth Hormone
Prevalence and Cardiovascular Effects of Growth Hormone Deficiency in Abdominal Obesity
Obesity is one of the leading causes of cardiovascular-related diseases, including diabetes and heart disease. Obesity, and more specifically abdominal obesity, may cause decreased growth hormone (GH) levels.
- Trial name
- NCT00562796
- Where
- United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Hypothalamic Obesity
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life…
- Trial name
- NCT06046443
- Testing
- LB54640
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Low-Calorie Diet, Diet, High-Protein
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling
The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases.
- Conditions
- Low-Calorie Diet, Diet, High-Protein, Obesity; Pituitary, Weight Cycling
- Trial name
- NCT03374150
- Testing
- diet counseling
- Where
- 2 sites in Indonesia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Prader-Willi Syndrome, Hypothalamic Obesity
Tirzepatide in PWS, HO and GNSO
This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated…
- Conditions
- Prader-Willi Syndrome, Hypothalamic Obesity, Obesity/Therapy
- Trial name
- NCT06901245
- Testing
- Tirzepatide
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Grace Kim