Efficacy and Safety of THR-4109 in Obese Subjects

Theracos

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: THR-4109

Study type: Interventional

Funder types: Industry

Identifiers

NCT00485017

THR-4109-C-302

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks

Treatment:

Drug: THR-4109

2

Experimental group

Description:

THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks

Treatment:

Drug: THR-4109

3

Experimental group

Description:

THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks

Treatment:

Drug: THR-4109

4

Placebo Comparator group

Treatment:

Drug: Placebo