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Efficacy and Safety of THR-4109 in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485017
First Posted: June 12, 2007
Last Update Posted: July 2, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TFS Trial Form Support
Information provided by:
Theracos
  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 (Participant, 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

Further study details as provided by Theracos:

Primary Outcome Measures:
  • Percent change from baseline weight [ Time Frame: 24 weeks ]

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 ]
  • Serum lipids, waist circumference, fasting plasma glucose and blood pressure [ Time Frame: 24 weeks ]
  • Safety and tolerability of THR-4109 [ Time Frame: 24 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485017


Locations
Russian Federation
Investigational Site #62
Arkhangelsk, Russian Federation, 163045
Investigational Site #61
Moscow, Russian Federation, 107014
Investigational Site #51
Moscow, Russian Federation, 117036
Investigational Site #60
Moscow, Russian Federation, 121069
Investigational Site #57
Moscow, Russian Federation, 123056
Investigational Site #50
Moscow, Russian Federation, 125315
Investigational Site #54
Moscow, Russian Federation, 129010
Investigational Site #56
Saratov, Russian Federation, 410018
Investigational Site #63
St. Petersburg, Russian Federation, 192283
Investigational Site #67
St. Petersburg, Russian Federation, 194291
Investigational Site #53
St. Petersburg, Russian Federation, 194354
Investigational Site #66
St. Petersburg, Russian Federation, 194354
Investigational Site #59
St. Petersburg, Russian Federation, 195267
Investigational Site #65
St. Petersburg, Russian Federation, 197110
Investigational Site #55
St. Petersburg, Russian Federation, 197198
Investigational Site #58
St. Petersburg, Russian Federation, 198134
Investigational Site #64
St. Petersburg, Russian Federation, 199178
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

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
First Submitted: June 8, 2007
First Posted: June 12, 2007
Last Update Posted: July 2, 2008
Last Verified: June 2008

Keywords provided by Theracos:
Obesity
Weight Loss