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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014