Efficacy and Safety of THR-4109 in Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
TFS Trial Form Support
Information provided by:
Theracos
ClinicalTrials.gov Identifier:
NCT00485017
First received: June 8, 2007
Last updated: June 30, 2008
Last verified: June 2008
  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 2

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

Resource links provided by NLM:


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
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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
Placebo Comparator: 4 Drug: Placebo
Oral capsules daily in a.m. and in p.m. for 24 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 #62
Arkhangelsk, Russian Federation, 163045
Investigational Site #50
Moscow, Russian Federation, 125315
Investigational Site #51
Moscow, Russian Federation, 117036
Investigational Site #54
Moscow, Russian Federation, 129010
Investigational Site #61
Moscow, Russian Federation, 107014
Investigational Site #57
Moscow, Russian Federation, 123056
Investigational Site #60
Moscow, Russian Federation, 121069
Investigational Site #56
Saratov, Russian Federation, 410018
Investigational Site #58
St. Petersburg, Russian Federation, 198134
Investigational Site #59
St. Petersburg, Russian Federation, 195267
Investigational Site #63
St. Petersburg, Russian Federation, 192283
Investigational Site #53
St. Petersburg, Russian Federation, 194354
Investigational Site #55
St. Petersburg, Russian Federation, 197198
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 #12
Dalby, Sweden, SE-240 10
Investigational Site #11
Gothenburg, Sweden, SE-411 36
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: Dr. E. Amento, President and CEO, Theracos, Inc
ClinicalTrials.gov Identifier: NCT00485017     History of Changes
Other Study ID Numbers: THR-4109-C-302
Study First Received: June 8, 2007
Last Updated: June 30, 2008
Health Authority: Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency

Keywords provided by Theracos:
Obesity
Weight Loss

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014