Efficacy and Safety of THR-4109 in Obese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: THR-4109
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks | Drug: THR-4109<br>* 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<br>|
| Experimental: 2<br>THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks | Drug: THR-4109<br>* 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<br>|
| Experimental: 3<br>THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks | Drug: THR-4109<br>* 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<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Oral capsules daily in a.m. and in p.m. for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline weight |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Loss