Clinicaltrials.gov
 | Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones | Completed | Obesity | Drug, Drug - CE-326,597, Placebo | Pfizer, Industry | | 18 Years - 65 Years | Phase 1 | Interventional | The study is designed to assess whether repeated dosing with CE-326,597 will cause patients
with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become
symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597. | |
Clinicaltrials.gov
 | Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth | Completed | Obesity, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus | Drug, Drug - Rosiglitazone, Placebo | Yale University, Other | | 10 Years - 18 Years | N/A | Interventional | The purpose of the study is to determine whether treatment of children and adolescents with
Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin
sensitivity and glucose tolerance. | |
Clinicaltrials.gov
| Optimizing Body Composition for Function in Older Adults | Completed | Obesity, Overweight With Indications for Weight Loss | Drug, Behavioral, Behavioral, Drug - Pioglitazone, Resistance exercise training to maximize muscle power, Hypocaloric diet, Placebo | Wake Forest University Health Sciences, Takeda Pharmaceuticals North America, Inc., National Institute on Aging (NIA), Other, Industry, NIH | | 65 Years - 79 Years | Phase 4 | Interventional | The purpose of this pilot study is to compare two strategies intended to improve the health
of overweight older adults by improving body composition. One strategy, resistance training,
is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ
agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These
strategies will be used in conjunction with a hypocaloric diet and will be compared to a
hypocaloric diet alone to determine if either of these strategies are superior in reducing
visceral fat and preserving muscle mass. | |
Clinicaltrials.gov
| Primary Prevention of Hypertension in Obese Adolescents | Completed | Obesity, Pre-Hypertension, Hyperuricemia | Drug, Drug, Drug - Allopurinol, Probenecid, Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor University, NIH, Other | | 11 Years - 18 Years | Phase 2 | Interventional | The purpose of this study is to examine the consequences of lowering serum uric acid in
pre-hypertensive, obese adolescents pathways involved with how uric acid mediated
hypertension and renal disease. The specific aims are:
1. Test the hypothesis that lowering uric acid will improve endothelial function.
2. Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum
angiotensin II levels.
3. Test the hypothesis that lowering uric acid will reduce markers of inflammation | |
Clinicaltrials.gov
| Sit Less, Interact and Move More (SLIMM) 2 Study | Recruiting | Chronic Kidney Diseases, Obesity | Behavioral, Behavioral, Behavioral, Drug, Drug - SLIMM, Standard Resistance Training, Guided Resistance Training, Placebo, Semaglutide | Srinvasan Beddhu, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, Other, NIH, Other | | 20 Years - N/A | Phase 2 | Interventional | - Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function,
obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney
function and increased risk of diabetes, heart disease and death.
- In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move
More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was
able to decrease prolonged sitting but that effect was not sustained.
- Therefore, the researchers are currently conducting a follow-up study named Sit Less,
Interact and Move More (SLIMM) 2.
- This NIH funded study is conducted at the University of Utah and Stanford University.
- The purpose of this study is to see if guided resistance training (to improve muscle
strength) and semaglutide (FDA approved diabetes and weight loss medication that might
also improve physical function) can boost adherence to the SLIMM Intervention and reduce
sedentary behavior. | |
Clinicaltrials.gov
| The Influence of GNiib® in Obesity Management in Obese Young Individuals in Hong Kong. | Not yet recruiting | Obesity | Dietary Supplement, Dietary Supplement - G-Niib, Placebo | Chinese University of Hong Kong, Other | | 25 Years - 30 Years | N/A | Interventional | Obesity is a global epidemic, and is an important cardio-metabolic risk factor associated
with many non-communicable diseases, such as coronary artery disease (CAD), diabetes and
non-alcoholic fatty liver diseases (NAFLD) (1-6). In 2010, our team recruited a cohort of
obese adolescents [mean age at baseline: 17.2 years, mean body mass index (BMI): 30.9 kg/m2]
from school surveys (7). Our group has examined the impact of dietary intervention using low
glycemic index (GI) diet to reduce body weight of adolescents. We have reported that
participants in the low GI group had a significantly greater reduction in obesity indices
namely waist circumference after 6 months of intervention compared to counterparts in usual
diet counselling group. We recently conducted a phone interview of the participants and most,
if not all, of them remained obese from self-reported body weight. Pharmacological treatment
options for obese individuals are limited (8-10). Amassing evidence showed that the gut
microbiota plays an important role in energy harvesting and lipid metabolism. Gut microbiota
dysbiosis was repeatedly reported in patients with obesity (11-13). Studies in humanized
mouse models suggest that the obese gut microbiota was more efficient in harvesting energy
from diet and may be a causative factor in the pathogenesis of metabolic disorders, including
obesity, type 2 diabetes and NAFLD (14). Therefore, modulation of microbiota might be a
potential strategy for prevention and treatment of metabolic disorders. Microbial-based
therapeutics such as probiotics, prebiotics, symbiotic or fecal microbiota transplantation
have shown promising effect in improving host metabolic health (15, 16). Prebiotics
consumption changes the composition of gut microbiota, alters levels of satietogenic gut
peptides, decreases systemic inflammation, and improves insulin sensitivity and glucose
tolerance (17). Supplementation of probiotics in overweight and obese individuals with
probiotics reduces body weight and obesity indices (16, 18, 19). The use of probiotics also
reduces intrahepatic triglyceride (IHTG) in patients with non-alcoholic steatohepatitis (20)
and improves post-prandial glucose control in subjects with type 2 diabetes (21). G-NiiB®, a
patent-protected microbiome immunity formula, composed of naturally occurring food-grade
bacteria approved by health authorities, has been developed by a group of CUHK
gastroenterology experts. | |
Clinicaltrials.gov
| The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery | Not yet recruiting | Obesity, Type 2 Diabetes | Dietary Supplement, Other - Hafnia alvei HA4597™, Placebo | Universidade Nova de Lisboa, Academia CUF, Other, Other | | 18 Years - 65 Years | N/A | Interventional | This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on
weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y
gastric bypass will receive probiotics or placebo, twice a day, for 60 days, one month after
surgery. Outcomes will be measured at baseline, and 1, 3, 6, 9 and 12 months after the
surgery. | |
Clinicaltrials.gov
| Study to Evaluate ARD-101 in Adults With Obesity | Recruiting | Obesity | Drug, Drug - ARD-101, Placebo | Aardvark Therapeutics, Inc., University of California, San Diego, Industry, Other | | 18 Years - 75 Years | Phase 2 | Interventional | The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in obese
subjects with a body mass index (BMI) of 30-45 kg/m2. | |
Clinicaltrials.gov
| Latino Semaglutide Study | Not yet recruiting | Obesity, Obesity, Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body | Drug, Drug - Semaglutide 2.4mg, Placebo | Warren Peters, MD, MPH, Novo Nordisk A/S, Other, Industry | | 18 Years - 75 Years | Phase 3 | Interventional | The purpose of this study to understand better how this anti-obesity medication works to
assist individuals to lose weight and maintain weight loss. This study may lead to the
development of other related medications for assisting people with the disease of obesity. | |
Clinicaltrials.gov
| Effect of Sea Grapes-antioxidants Extract in Obese Men : 4 Weeks Randomized-Double Blind Controlled Trial | Completed | Obesity, Aging, Diabetes | Drug, Drug - Sea grapes extract 1.68 g/70kg BW, Placebo | State Islamic University of Sunan Kalijaga Yogyakarta, Other | Male | 19 Years - 60 Years | Early Phase 1 | Interventional | Doses of 150 mg/kg BW (30 mg/200g BW) sea grape extract in a previous pre-clinical trial,
showed that it could improve blood glucose, total cholesterol and serum PGC-1 levels in rats
fed a diet high in fat and cholesterol. In addition, you also have hepatoprotective activity
(aka non-toxic) in diabetic mice. Previous research, is an in vivo (Pre-clinical) study that
has not represented the benefits or efficacy of sea grape extract on variables tested in
humans. Therefore, this clinical trial was conducted to support the effect of sea grape
extract-antioxidant on blood glucose, total cholesterol, and PGC-1 levels in obese men for 4
weeks using a Randomized-Double Blind Controlled Trial. | |
Clinicaltrials.gov
| Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults | Completed | Obesity, Superoxide Dismutase | Dietary Supplement, Combination Product - Saccharomyces boulardii and SOD, Placebo | Azienda di Servizi alla Persona di Pavia, Other | | 30 Years - 65 Years | N/A | Interventional | In animals it has been demonstrated that Saccharomyces boulardii decrease low-grade
inflammation and fat mass; also Superoxide Dismutase (SOD) decrease low-grade inflammation.
Therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the
effect of a 60-days S. boulardii and SOD supplementation on circulating markers of
inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid
profile, glucose, insulin and HOMA-IR, in obese adults (BMI 30-35 kg/m2). | |
Clinicaltrials.gov
| A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT) | Recruiting | Obesity, Heart Failure With Preserved Ejection Fraction | Drug, Other - Tirzepatide, Placebo | Eli Lilly and Company, Industry | | 40 Years - N/A | Phase 3 | Interventional | The main purpose of this study is to assess the efficacy and safety of Tirzepatide
(LY3298176) in participants with heart failure with preserved ejection fraction and obesity. | |
Clinicaltrials.gov
| SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity | Recruiting | Obesity | Drug, Drug - Liraglutide, Placebo | Novo Nordisk A/S, Industry | | 6 Years - 12 Years | Phase 3 | Interventional | The study looks at how liraglutide works on participant's body weight. Researchers will look
at how liraglutide can help children with obesity to lose weight. They will look at how much
weight the children will lose, and if there are any side effects.
Participants will either get liraglutide or placebo. Which treatment the participants get is
decided by chance. Liraglutide is a new medicine for children, but it can already be
prescribed by doctors to adults with overweight or obesity. The participant will get 1
injection every day.
In addition to taking the medicine, the participants will have talks with the study staff
about healthy food choices, how they can be more physically active and what can be done to
help the participants to lose weight.
The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic
visits and 10 phone or video calls with the study doctor/staff. Participant will have blood
samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary
between some of the visits. | |
Clinicaltrials.gov
| Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults | Recruiting | Obesity, Overweight and Obesity | Dietary Supplement, Dietary Supplement - B. breve, Placebo | Morinaga Milk Industry Co., LTD, KGK Science Inc., Industry, Industry | | 20 Years - 65 Years | N/A | Interventional | Overweight has become a critical issue in North America and the market value of weight loss
products is expected to rise as the population becomes more health-conscious and aware of the
risks associated with excess body weight. This randomized, placebo-controlled, clinical trial
investigates the effect of Bifidobacterium breve supplementation with exercise intervention
on fat loss. | |
Clinicaltrials.gov
| A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss | Active, not recruiting | Obesity, Overweight | Drug, Other - Tirzepatide, Placebo | Eli Lilly and Company, Industry | | 18 Years - N/A | Phase 3 | Interventional | This is a study of tirzepatide in participants with obesity or overweight. The main purpose
is to learn more about how tirzepatide maintains body weight loss. The study has two phases:
a lead-in phase in which all participants take tirzepatide and a treatment phase in which
participants will either continue tirzepatide or switch to placebo. The study will last about
2 years (25 visits). | |
Clinicaltrials.gov
| The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia. | Completed | Insulin Sensitivity, Obesity, Overweight | Dietary Supplement, Other - 500 mg of artichoke extract, Placebo | Azienda di Servizi alla Persona di Pavia, Indena S.p.A, Other, Industry | | 18 Years - N/A | N/A | Interventional | Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk
of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts
due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate
translocase and of dicaffeoylquinic acid derivatives that modulate the activity of
alpha-glucosidase. Given this background, we investigated whether a new highly standardized
Cs extract could improve glycaemic control, insulin sensitivity and other metabolic
parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference,
Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG. | |
Clinicaltrials.gov
| The Role of Secretin on the Energy Homeostasis | Completed | Obesity, Metabolic Disease, Diabetes, Adiposity | Drug, Other - Secretin, Placebo | Steno Diabetes Center Copenhagen, Other | Male | 18 Years - 75 Years | N/A | Interventional | As of last year, new insight into the function of secretin was brought about as rodent
studies showed secretin to possess potential body weight-regulating effects. In these
studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue
(BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these
regulatory effect of secretin on energy homeostasis are unclear, | |
Clinicaltrials.gov
| Empagliflozin and Atrial Fibrillation Treatment | Not yet recruiting | Atrial Fibrillation, Heart Failure, Obesity, Diabetes Mellitus | Drug, Other - Empagliflozin, Placebo | Miulli General Hospital, Other | | 18 Years - 80 Years | Phase 4 | Interventional | The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared
with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial
fibrillation. | |
Clinicaltrials.gov
| Dose-ranging Study of SKF7™ for Obesity | Completed | Obesity | Drug, Drug, Drug, Drug - low-dose, Middle-dose, Higher-dose, Placebo | Indonesia University, Medika Natura Sdn Bhd, Other, Other | | 18 Years - 50 Years | Phase 2 | Interventional | This study has been designed as a randomized, double blinded, multi-centric, placebo
controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients
from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™). | |
Clinicaltrials.gov
| MicroFIBERgut: Effects of Lifestyle Changes and Chitosan on Gut Microbiota and Weight Management | Recruiting | Obesity, Lifestyle | Behavioral, Dietary Supplement, Other - Lifestyle changes, Chitosan, Placebo | University of Iceland, Matís ohf, Reykjalundur Rehabilitation Center, Primex ehf, Other, Other, Other, Industry | Female | 18 Years - 80 Years | N/A | Interventional | The purpose of this study is to compare the effects of chitosan diet supplementation to a
placebo supplement on changes in gut microbiota, body weight and different health parameters
among different population groups, being either obese (BMI 30-50) and undertaking major
changes in lifestyle (patients) or being those not undergoing any major lifestyle changes
(volunteers, BMI 18.5-35). | |
Clinicaltrials.gov
| Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity | Active, not recruiting | Obesity | Biological, Drug - AMG 133, Placebo | Amgen, Industry | | 18 Years - 65 Years | Phase 1 | Interventional | The study aims to assess the safety and tolerability of AMG 133 as single and multiple doses
in participants with obesity | |
Clinicaltrials.gov
| Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker | Recruiting | Obesity | Drug, Drug, Other - Phentermine-Topiramate Extended Release, Placebo, Online support system | Mayo Clinic, Other | | 18 Years - 75 Years | Phase 4 | Interventional | Researchers are assessing the effects of weight loss medication vs a placebo among
participants provided with a wearable activity tracker, digital wellness devices and
lifestyle recommendations. | |
Clinicaltrials.gov
| Alpha and Omega of Lifestyle Therapy | Active, not recruiting | Obesity | Other, Dietary Supplement, Dietary Supplement - Resistance exercise, Omega-3, Placebo | Inland Norway University of Applied Sciences, Other | | 30 Years - 60 Years | N/A | Interventional | The study aims to investigate the effects of double-blinded, randomized placebo-controlled
n3-fatty acid supplementation (1000 mg day-1) and 13 weeks of resistance training on muscle
function/biology and systemic health in individuals with obesity (BMI>30) and lean
individuals (BMI<30) | |
Clinicaltrials.gov
| A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight | Active, not recruiting | Overweight, Obesity | Drug, Drug - Tirzepatide, Placebo | Eli Lilly and Company, Industry | | 18 Years - N/A | Phase 3 | Interventional | This is a study of tirzepatide in participants with overweight and obesity. The main purpose
is to learn more about how tirzepatide affects body weight. The study has two phases: A main
phase and an extension phase. The main phase of the study will last 72 weeks (14 visits).
Participants with prediabetes will continue in the extension for another 2 years. | |
Clinicaltrials.gov
| Effect of Entacapone on Bodyweight Loss in Obese Population | Unknown status | Obesity | Drug, Drug - Entacapone, Placebo | Kaichun Wu, National Institute of Biological Sciences, Beijing, Other, Other | | 18 Years - 60 Years | Phase 1/Phase 2 | Interventional | This is a randomized, controlled, double blind clinical trial. The purpose of this study is
to investigate the weight loss efficacy of entacapone. In this study, participants are
randomly divided into entacapone and placebo groups. The percentage change in body weight,
the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat,
serum insulin, serum triglyceride and the adverse effects are compared between the two
groups. | |
Clinicaltrials.gov
| Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients | Completed | Obesity | Drug, Drug - Dietressa, Placebo | Materia Medica Holding, Industry | | 18 Years - 65 Years | Phase 3 | Interventional | The purpose of this study is:
- To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in
treatment of obese patients.
- To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks
of therapy in reducing body weight in obese patients.
- To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times
daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients. | |
Clinicaltrials.gov
| Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue | Completed | Obesity | Drug, Drug - AZD4017, Placebo | AstraZeneca, Industry | Male | 18 Years - 65 Years | Phase 1 | Interventional | The primary purpose of this study is to investigate different methods to evaluate the effect
of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese
but otherwise healthy subjects. | |
Clinicaltrials.gov
| A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients | Not yet recruiting | Obesity | Drug, Drug - HSG4112, Placebo | Glaceum, Gangnam Severance Hospital, Seoul National University Bundang Hospital, Korea University Anam Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center, Industry, Other, Other, Other, Other, Other | | 19 Years - 70 Years | Phase 2 | Interventional | 1. Study Objective
- To assess the effect of HSG4112 on body weight
- To evaluate the safety and tolerability of HSG4112
2. Background
Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic
properties of HSG4112 in healthy subjects through its Phase 1 trials, and is planning to
perform this Phase 2a trial to assess the safety and efficacy of HSG4112 in overweight
and obese patients.
3. Number of Subjects
This study is a Phase 2a clinical trial designed to evaluate the safety and efficacy of
HSG4112 following multiple-dose administration. The subject sample size estimate for the
primary efficacy endpoint was based on total body weight, and assumes repeated
measurement of body weight occurs at Baseline and every 4 weeks thereafter during the
12-week treatment period. Based on similar weight loss studies with obesity drugs, the
covariance matrix for body weight change over time is estimated as AR(1) (sigma = 3.07,
rho = 0.9). Thus, with 20 subjects completing each treatment group, this study can
detect a mean difference of 6 kg between HSG4112 and matching placebo treatments with
80% power, assuming a two-sided α-level of 0.05. Therefore, the target sample size for
this study is 20 subjects/group.
4. Study Design and Protocol
This study is a randomized, double-blind, placebo-controlled, parallel-groups trial. Subjects
deemed eligible to participate in this study based on the inclusion/exclusion criteria will
be assigned a subject number and randomized to one of the 4 treatment groups - 1 group
receiving placebo - in a 1:1:1:1 ratio. Subjects will be randomized to double-blind
treatments and will receive a once-daily oral dose of the investigational product for 12
weeks according to the study protocol. Body weight and obesity/metabolism-related parameters
will be evaluated to assess the efficacy of HSG4112. Assessments including measurement of
vital signs, 12-lead ECG, clinical laboratory tests, pregnancy test, physical examination,
and adverse event monitoring will be performed to evaluate the safety and tolerability of
HSG4112. Blood samples will be collected for pharmacokinetic assessment and samples from
subjects who have signed the consent form for the exploratory genetic research will undergo
analysis to detect PON2 gene polymorphism. | |
Clinicaltrials.gov
| Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM | Not yet recruiting | Obesity | Drug, Drug - MBL949, Placebo | Novartis Pharmaceuticals, Industry | | 18 Years - 60 Years | Phase 2 | Interventional | The purpose of this study is to assess the safety, tolerability, efficacy, and
pharmacokinetics (PK) of subcutaneous (SC) MBL949 in obese participants with or without type
2 diabetes mellitus (T2DM) on weight loss. | |
Clinicaltrials.gov
| The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure | Recruiting | Heart Failure, Obesity | Drug, Drug - Empagliflozin 10 MG, Placebo | Jacob Moller, Danish Heart Foundation, Herlev and Gentofte Hospital, University Hospital Bispebjerg and Frederiksberg, Hillerod Hospital, Denmark, Rigshospitalet, Denmark, Other, Other, Other, Other, Other, Other | | 60 Years - 84 Years | Phase 2 | Interventional | The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes,
cardiac biomarkers, metabolism, daily activity level, health-related quality of life in
patients in elderly and obese patients with increased risk of developing heart failure. The
primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1)
reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption)
compared with placebo. | |
Clinicaltrials.gov
| The Effect of Liraglutide on the GIT | Unknown status | Obesity | Drug, Drug - 0.6 mg Liraglutide, Placebo | Universitaire Ziekenhuizen Leuven, Other | | 18 Years - 65 Years | Phase 4 | Interventional | Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss
treatment. Its mechanism of action has not yet been elucidated. We want to investigate
whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole
blood levels, hunger ratings and ad libitum food intake in healthy volunteers. | |
Clinicaltrials.gov
| Effect of Hydroxychloroquine Sulphate in Healthy Lean Females | Unknown status | Obesity | Drug, Drug - Hydroxychloroquine Sulphate, Placebo | Universitaire Ziekenhuizen Leuven, Other | Female | 18 Years - 65 Years | Phase 4 | Interventional | The effect of an acute administration of hydroxychloroquine sulphate will be investigated on
hedonic food intake, appetite related sensations and gastrointestinal hormone release in
healthy female subjects. | |
Clinicaltrials.gov
| A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity | Completed | Overweight, Obesity | Drug, Drug - Semaglutide, Placebo | Novo Nordisk A/S, Industry | | 18 Years - 65 Years | Phase 1 | Interventional | This study will look at how the emptying of the participant's stomach after a meal is
affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the
study will also look at the effect of semaglutide on the participant's appetite and energy
intake. Participants will either get semaglutide or "dummy" medicine - which treatment any
participant gets is decided by chance. Participants will take 1 injection per week. The study
medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will
last for about 27 weeks (from first treatment to last check-up). Participants will have 8
visits at the clinic with the study doctor. | |
Clinicaltrials.gov
| Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat | Unknown status | Obesity | Dietary Supplement, Dietary Supplement - Soybean Germ Extract, Placebo | Chonbuk National University Hospital, Other | | 19 Years - 65 Years | N/A | Interventional | This study was conducted to investigate the effects of daily supplementation of Soybean germ
extract on decrease of body fat | |
Clinicaltrials.gov
| Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2) | Completed | Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity | Drug, Drug - Testosterone Undecanoate, Placebo | University Medical Centre Ljubljana, Other | Male | 35 Years - N/A | Phase 4 | Interventional | Aim of the study was to investigate the effects of testosterone replacement therapy on
components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic
fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life. | |
Clinicaltrials.gov
| Investigating the Role of Ghrelin in Regulating Appetite and Energy Intake in Patients Following Bariatric Surgery (BARI-INSIGHT) | Completed | Obesity, Bariatric Surgery Candidate, Appetitive Behavior | Drug, Other - GLWL-01, Placebo | University College, London, Other | | 18 Years - 64 Years | N/A | Interventional | Bariatric surgery helps patients with severe obesity to lose weight, cures and prevents
diseases linked to obesity and reduces the risk of death. Unfortunately, 1 in 5 patients do
not respond well to surgery in terms of weight loss and health gains. Thus, maximising weight
loss and health benefits after surgery is critical. This study aims to gain insight into the
role that the appetite-stimulating hormone, ghrelin, plays in driving appetite and energy
intake in patients with poor weight loss (≤ 20% total body weight) following bariatric
surgery. This will guide future work to develop pharmacological treatments for obesity, both
as standalone treatments and adjuncts to bariatric surgery.
Participants will be invited to attend the Clinical Research Facility at University College
London Hospital for a screening visit and six study visits. Active ghrelin levels will be
reduced by inhibiting ghrelin-o-acyl-transferase (GOAT), the enzyme needed to generate active
ghrelin (acyl ghrelin, AG). Participants will be randomised to receive GLWL-01 (GOAT
inhibitor) 300mg BD or placebo for a 10 day study cycle. The effect of AG reduction on
appetite and energy intake will be evaluated through both fixed-energy and ad libitum meal
tests on day 7 and 10, respectively. Measures of body weight and composition, appetite and
food cravings will be performed in addition to biochemical profiling of circulating gut
hormone, adipokine and cytokine levels. Targeted physical examinations and assessment of
adverse events will be performed. Safety monitoring calls will be conducted 2 and 7 days
after the last dose. Following a 6-10 week washout period, participants will cross over to
receive either placebo or GLWL-01 300mg BD and undergo a second study cycle, with all
measures repeated. | |
Clinicaltrials.gov
| A Study to Test Different Doses of BI 456906 in Patients With Obesity | Completed | Obesity | Drug, Drug - BI 456906, Placebo | Boehringer Ingelheim, Industry | | 18 Years - 70 Years | Phase 1 | Interventional | Main objective is to investigate the tolerability of different titration schemes of BI 456906
in otherwise healthy patients with obesity/overweight, and to determine a titration scheme
for future studies. | |
Clinicaltrials.gov
| Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism | Recruiting | Hypogonadism, Hypogonadotropic, Obesity | Drug, Drug - anastrozole (1 mg/day), Placebo | Baylor College of Medicine, Other | Male | 40 Years - 65 Years | Phase 4 | Interventional | The investigators have preliminary data suggesting that obese patients with hypogonadotropic
hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its
conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased
conversion of androgens into estrogens in obese men results in a negative feedback of high
estradiol levels on hypothalamus and pituitary, inhibiting the production of
gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating
hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone
administration could increase estradiol production, further promoting the inhibitory feedback
to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification
has been shown to reduce estradiol and increase testosterone levels, the effect is at best
modest and weight regain results in recurrence of hypogonadism. The use of aromatase
inhibitors, in combination with weight loss, could be an effective alternative strategy due
to its action at the pathophysiology of the disease.
Intervention Subjects (body mass index of ≥35, testosterone <300 ng/dl) will be randomized to
the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be
self-administered with or without food, at around the same time every day (active group);
placebo 1 tablet/day with or without food to take at around the same time every day (control
group). The study duration will be 12 months.
Both groups will undergo lifestyle intervention consisting of diet and supervised exercise
program. Target weight loss will be at least 10% of baseline body weight during the
intervention. Subjects will attend weekly group behavior modification sessions which will
last ~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months.
Subjects will attend supervised research center-based exercise sessions during the first 6
months followed by community fitness center-based sessions during the next 6 months for at
least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week. | |
Clinicaltrials.gov
| Effect of Melatonin on Cardiometabolic Risk- FULL | Unknown status | Obesity, Prediabetic State | Drug, Drug - Melatonin, Placebo | Brigham and Women's Hospital, Other | | 18 Years - N/A | Phase 3 | Interventional | In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity
(BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive
either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour
before bed. The investigators will assess melatonin's effect on insulin sensitivity by
performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured
using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating
melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood
pressure, and potential intermediates including endothelial function using brachial
ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion,
and renin-angiotensin system activation using measurements of plasma renin activity,
angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate
melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as
well as high sensitivity C-reactive protein, IL-6, and TNF-α.
There will be a 24 week cohort phase as an extension of the trial. This will be an open-label
prospective study of 50 subjects recruited from the trial who will take 2 mg of
controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At
the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again
assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control
(HbA1, fasting glucose). | |
Clinicaltrials.gov
| Naltrexone/Bupropion Cardiovascular Outcomes Study | Terminated | Obesity, Cardiovascular Diseases | Drug, Drug - Naltrexone HCl/Bupropion HCl ER, Placebo | Orexigen Therapeutics, Inc, Industry | | 18 Years - N/A | Phase 4 | Interventional | The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone
hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo
and rule out excess risk of major adverse cardiovascular events (MACE) when given in
combination with standard of care in overweight and obese participants with documented
history of CV disease. | |
Clinicaltrials.gov
| Daily Tadalafil on Body Fat and Lean Mass | Completed | Obesity, Sexual Dysfunction | Drug, Drug - Tadalafil, Placebo | University of Roma La Sapienza, Other | Male | 18 Years - 65 Years | Phase 4 | Interventional | Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported.
However, a better understanding of the complex role of PDE5 in fat metabolism and whole body
homeostasis requires the use of transgenic animal models either lacking or overexpressing
PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and
metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of
expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral vs.
subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low calorie
intake) could reveal if PDE5 can be considered to be a reliable 'marker' of metabolic
dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5 inhibitor
sildenafil in a mouse model of diet-induced insulin resistance caused a significant
improvement in insulin sensitivity . Also, in humans chronic exposure to tadalafil confirmed
an improvement of insulin sensitivity in men with erectile dysfunction. However, the efficacy
of long-term treatment with PDE5i awaits demonstration in human metabolic diseases such as
obesity and insulin resistance.
The primary purpose of the study is to investigate the effects of tadalafil taken once a day
on body composition in men with sexual distress and/or erectile dysfunction. | |
Clinicaltrials.gov
| Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women | Completed | Obesity | Dietary Supplement, Dietary Supplement - Globes®, Placebo | Istituto Auxologico Italiano, Other | Female | 18 Years - N/A | Phase 4 | Interventional | This study evaluates whether supplementations with a highly bioavailable green tea extract
may help obese women to counteract weight regain after a 3-month weight loss intervention. | |
Clinicaltrials.gov
| Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn | Completed | Pregnancy, Obesity, Gestational Diabetes Mellitus | Dietary Supplement, Dietary Supplement - Vivomixx®, Placebo | Hvidovre University Hospital, University of Copenhagen, Statens Serum Institut, Other, Other, Other | Female | 18 Years - N/A | Phase 4 | Interventional | The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational
weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight
body composition of their infants. | |
Clinicaltrials.gov
| Probiotics in Diabesity: A Pilot Study | Completed | Diabetes, Obesity | Dietary Supplement, Dietary Supplement - Winclove 851 and 110, Placebo | Medical University of Graz, Other | | 18 Years - 99 Years | N/A | Interventional | Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality.
Probiotic modulation of gut flora is a possible therapeutic mechanism.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies
probiotic on glycaemic control, gut microbiota and gut permeability in patients with
metabolic syndrome and diabetes. | |
Clinicaltrials.gov
| The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism | Completed | Change of Transit or Circulation, Obesity | Dietary Supplement, Dietary Supplement - soluble wheat bran fibre, Placebo | Maastricht University Medical Center, Other | | 20 Years - 50 Years | N/A | Interventional | The study will investigate the effect of cereal based prebiotic fibres on intestinal health
and functioning and host metabolism. | |
Clinicaltrials.gov
| Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients | Completed | Obesity, Premature Recovery From Anesthesia | Drug, Drug - Nuvigil, Placebo | University of Texas Southwestern Medical Center, Other | | 18 Years - 75 Years | Phase 3 | Interventional | Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative
morbidity and mortality. This group of patients is at risk of perioperative desaturations
which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA
patients might also need to spend the night in intensive care for more frequent monitoring
for any desaturations episodes especially if the patient will be requiring multiple
intravenous narcotic boluses for pain control. Several studies have looked into the most
appropriate way to manage these patients and some recommendations have been made to avoid
outpatient surgery with close monitoring for first 24 hours after surgery specifically if
patient will require intravenous postoperative narcotics.
Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA
approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and
obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or
modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown.
Nuvigil is longer acting product which is similar in action to Modafinil however is much
cheaper. Nuvigil has not been previously studied for postoperative recovery. The
investigators intend to study the effects of Nuvigil on postoperative recovery time and
wakefulness in obstructive sleep apnea and obese patients. | |
Clinicaltrials.gov
| Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans | Unknown status | Hypertension, Obesity, Stress, Psychological, Blood Pressure | Drug, Other - Irbesartan, Placebo | Augusta University, Other | | 18 Years - 50 Years | Phase 2 | Interventional | The purpose of this study is to test the hypothesis that hypertension increases the
anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in
overweight/obese African-American's who retain sodium during mental stress. | |
Clinicaltrials.gov
| Cardiometabolic Disease and Pulmonary Hypertension | Terminated | Obesity | Drug, Drug - Metformin, Placebo | Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | | 30 Years - 80 Years | Early Phase 1 | Interventional | This study will investigate if metformin can help people with obesity and high pressures
inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug
Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat
pulmonary hypertension.
This study will examine whether Metformin will improve the high pressure inside lung blood
vessels in people who are obese. The study will help understand the effect of metformin on
pressures inside lung blood vessels. | |
Clinicaltrials.gov
| Effects of Alpha Lipoic Acid Supplementation on Metabolic Syndrome Markers in Young Overweight or Obese Males | Completed | Metabolic Syndrome, Obesity | Dietary Supplement, Dietary Supplement - Alpha Lipoic Acid Supplement, Placebo | University of La Verne, Other | Male | 18 Years - 35 Years | N/A | Interventional | Eight weeks supplementation of alpha lipoic acid (known superantioxidant already produced by
the body) will significantly improve metabolic syndrome markers (e.g., excess body weight,
blood pressure, glucose, insulin, blood lipids, and self-report measures) in young (18-25
years) overweight or obese males compared to placebo (cellulose starch). If the hypothesis is
supported, alpha lipoic acid ingestion could be beneficial in reducing disease risk and
enhancing metabolic dysfunction in ethnic individuals. Therefore, the purpose is to establish
the impact alpha lipoic acid has on the modifiable markers associated with metabolic
perturbations consistent with metabolic syndrome in males. | |
Clinicaltrials.gov
| Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat | Completed | Obesity | Dietary Supplement, Dietary Supplement - Zingiber officinale Roscoe extract 200 mg, Placebo | Chonbuk National University Hospital, Other | | 19 Years - 65 Years | N/A | Interventional | This study was conducted to investigate the effects of daily supplementation of Zingiber
officinale Roscoe extract on body fat. | |
