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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

June 8, 2007
June 30, 2008
August 2007
June 2008   (final data collection date for primary outcome measure)
Percent change from baseline weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline weight [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00485017 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of THR-4109 in Obese Subjects
A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • 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
  • Drug: Placebo
    Oral capsules daily in a.m. and in p.m. for 24 weeks
  • Experimental: 1
    THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks
    Intervention: Drug: THR-4109
  • Experimental: 2
    THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks
    Intervention: Drug: THR-4109
  • Experimental: 3
    THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks
    Intervention: Drug: THR-4109
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Sweden
 
NCT00485017
THR-4109-C-302
No
Dr. E. Amento, President and CEO, Theracos, Inc
Theracos
TFS Trial Form Support
Study Director: Natalie J Warner, MD Theracos, Inc.
Theracos
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP