Efficacy and Safety of THR-4109 in Obese Subjects
This study has been completed.
Sponsor:
Theracos
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 19, 2013