Clinical trial NCT00485017: Efficacy and Safety of THR-4109 in Obese Subjects
Official title: A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Weight Loss
Lead sponsor: Theracos
Sponsor class: INDUSTRY
Collaborators: name: TFS Trial Form Support
First posted: 2007-06-12
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight
timeFrame: 24 weeks
measure: Serum lipids, waist circumference, fasting plasma glucose and blood pressure
timeFrame: 24 weeks
measure: Safety and tolerability of THR-4109
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site #62
city: Moscow
country: Russian Federation
facility: Investigational Site #61
city: Moscow
country: Russian Federation
facility: Investigational Site #51
city: Moscow
country: Russian Federation
facility: Investigational Site #60
city: Moscow
country: Russian Federation
facility: Investigational Site #57
city: Moscow
country: Russian Federation
facility: Investigational Site #50
city: Moscow
country: Russian Federation
facility: Investigational Site #54
city: Saratov
country: Russian Federation
facility: Investigational Site #56
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #63
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #67
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #53
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #66
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #59
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #65
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #55
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #58
city: St. Petersburg
country: Russian Federation
facility: Investigational Site #64
city: Dalby
country: Sweden
facility: Investigational Site #12
city: Gothenburg
country: Sweden
facility: Investigational Site #11
city: Malmo
country: Sweden
facility: Investigational Site #13
Study officials:
affiliation: Theracos, Inc.
name: Natalie J Warner, MD
role: STUDY_DIRECTOR
References: