Efficacy and Safety of THR-4109 in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485017
• Other study ID #: THR-4109-C-302
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2019
• Source: Theracos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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
Oral capsules daily in a.m. and in p.m. for 24 weeks

Locations

Country	Name	City	State
Russian Federation	Investigational Site #62	Arkhangelsk
Russian Federation	Investigational Site #50	Moscow
Russian Federation	Investigational Site #51	Moscow
Russian Federation	Investigational Site #54	Moscow
Russian Federation	Investigational Site #57	Moscow
Russian Federation	Investigational Site #60	Moscow
Russian Federation	Investigational Site #61	Moscow
Russian Federation	Investigational Site #56	Saratov
Russian Federation	Investigational Site #53	St. Petersburg
Russian Federation	Investigational Site #55	St. Petersburg
Russian Federation	Investigational Site #58	St. Petersburg
Russian Federation	Investigational Site #59	St. Petersburg
Russian Federation	Investigational Site #63	St. Petersburg
Russian Federation	Investigational Site #64	St. Petersburg
Russian Federation	Investigational Site #65	St. Petersburg
Russian Federation	Investigational Site #66	St. Petersburg
Russian Federation	Investigational Site #67	St. Petersburg
Sweden	Investigational Site #12	Dalby
Sweden	Investigational Site #11	Gothenburg
Sweden	Investigational Site #13	Malmo

Sponsors (2)

Lead Sponsor	Collaborator
Theracos	TFS Trial Form Support

Countries where clinical trial is conducted

Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline weight		24 weeks
Secondary	Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight		24 weeks
Secondary	Serum lipids, waist circumference, fasting plasma glucose and blood pressure		24 weeks
Secondary	Safety and tolerability of THR-4109		24 weeks