Efficacy and Safety of THR-4109 in Obese Subjects - Full Text View

Sponsors and Collaborators:	Theracos TFS Trial Form Support
Information provided by:	Theracos
ClinicalTrials.gov Identifier:	NCT00485017

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: THR-4109 Drug: Placebo	Phase II

MedlinePlus related topics: Obesity Weight Control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects

Further study details as provided by Theracos:

Primary Outcome Measures:

Percent change from baseline weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Serum lipids, waist circumference, fasting plasma glucose and blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability of THR-4109 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks	Drug: THR-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
2: Experimental THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks	Drug: THR-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
3: Experimental THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks	Drug: THR-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
4: Placebo Comparator	Drug: Placebo Oral capsules daily in a.m. and in p.m. for 24 weeks

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485017

Locations

Russian Federation
Investigational Site #50
Moscow, Russian Federation, 125315
Investigational Site #51
Moscow, Russian Federation, 117036
Investigational Site #53
St. Petersburg, Russian Federation, 194354
Investigational Site #54
Moscow, Russian Federation, 129010
Investigational Site #55
St. Petersburg, Russian Federation, 197198
Investigational Site #60
Moscow, Russian Federation, 121069
Investigational Site #57
Moscow, Russian Federation, 123056
Investigational Site #58
St. Petersburg, Russian Federation, 198134
Investigational Site #59
St. Petersburg, Russian Federation, 195267
Investigational Site #56
Saratov, Russian Federation, 410018
Investigational Site #61
Moscow, Russian Federation, 107014
Investigational Site #62
Arkhangelsk, Russian Federation, 163045
Investigational Site #63
St. Petersburg, Russian Federation, 192283
Investigational Site #64
St. Petersburg, Russian Federation, 199178
Investigational Site #65
St. Petersburg, Russian Federation, 197110
Investigational Site #66
St. Petersburg, Russian Federation, 194354
Investigational Site #67
St. Petersburg, Russian Federation, 194291
Sweden
Investigational Site #11
Gothenburg, Sweden, SE-411 36
Investigational Site #12
Dalby, Sweden, SE-240 10
Investigational Site #13
Malmo, Sweden, SE-205 02

Sponsors and Collaborators

Theracos

TFS Trial Form Support

Investigators

Study Director:

Natalie J Warner, MD

Theracos, Inc.

More Information

No publications provided

Responsible Party:	Theracos, Inc ( Dr. E. Amento, President and CEO )
Study ID Numbers:	THR-4109-C-302
Study First Received:	June 8, 2007
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00485017 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation; Sweden: Medical Products Agency

Keywords provided by Theracos:

Obesity
Weight Loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009