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Completed

NCT Number: NCT00485017

Efficacy and Safety of THR-4109 in Obese Subjects

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site #62, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THR-4109

Drug

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

Drug

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

Primary outcomes

  1. Percent change from baseline weight

    Time frame: 24 weeks

Secondary outcomes

  1. Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight

    Time frame: 24 weeks

  2. Serum lipids, waist circumference, fasting plasma glucose and blood pressure

    Time frame: 24 weeks

  3. Safety and tolerability of THR-4109

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Theracos

Industry

Collaborators

  • TFS Trial Form Support

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2007
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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