Efficacy and Safety of THR-4109 in Obese Subjects

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: THR-4109; Drug: Placebo

• Registration Number: NCT00485017
• Lead Sponsor: Theracos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-12
• Study Start: 2007-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	THR-4109	THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks
1	THR-4109	THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks
3	THR-4109	THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline weight	24 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight	24 weeks
Serum lipids, waist circumference, fasting plasma glucose and blood pressure	24 weeks
Safety and tolerability of THR-4109	24 weeks

Trial Locations

Locations (20)

Investigational Site #62; 🇷🇺 Arkhangelsk, Russian Federation

Investigational Site #61; 🇷🇺 Moscow, Russian Federation

Investigational Site #51; 🇷🇺 Moscow, Russian Federation

Investigational Site #60; 🇷🇺 Moscow, Russian Federation

Investigational Site #57; 🇷🇺 Moscow, Russian Federation

Investigational Site #50; 🇷🇺 Moscow, Russian Federation

Investigational Site #54; 🇷🇺 Moscow, Russian Federation

Investigational Site #56; 🇷🇺 Saratov, Russian Federation

Investigational Site #63; 🇷🇺 St. Petersburg, Russian Federation

Investigational Site #67; 🇷🇺 St. Petersburg, Russian Federation

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