Obesity
Conditions
Keywords
Obesity, Weight Loss
Brief summary
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
Interventions
DRUGTHR-4109
THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
DRUGPlacebo
Oral capsules daily in a.m. and in p.m. for 24 weeks
Sponsors
TFS Trial Form Support
Theracos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 30 to 60 years of age * Body mass index between 30 and 40 kg/m2 * Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study * Able and willing to give written informed consent
Exclusion criteria
* Weight loss of more than 3 kg in the previous 3 months * Current or previous use (within 3 months) of medications that influence weight * Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome * Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse * Current serious/unstable medical condition * Current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline weight | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight | 24 weeks |
| Serum lipids, waist circumference, fasting plasma glucose and blood pressure | 24 weeks |
| Safety and tolerability of THR-4109 | 24 weeks |
Countries
Russia, Sweden
Outcome results
None listed