Obesity
Conditions
Keywords
Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
Brief summary
This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.
Detailed description
The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited. This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.
Interventions
DRUGATHX-105 phosphate
includes diet, physical activity, and lifestyle modification
DRUGPlacebo
includes diet, physical activity, and lifestyle modification
Sponsors
Syneos Health
Healios K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Obese adults with a body mass index of 30-45 kg/m2
Exclusion criteria
* Pregnancy * Diabetes * Adults with serious or unstable current or past medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| vital signs, lipids/glucose, waist circumference | 12 weeks |
Outcome results
None listed