Efficacy and Safety of THR-4109 in Obese Subjects

September 27, 2019 updated by: Theracos

A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Investigational site #62
      • Moscow, Russian Federation, 107014
        • Investigational site #61
      • Moscow, Russian Federation, 117036
        • Investigational Site #51
      • Moscow, Russian Federation, 121069
        • Investigational site #60
      • Moscow, Russian Federation, 123056
        • Investigational site #57
      • Moscow, Russian Federation, 125315
        • Investigational site #50
      • Moscow, Russian Federation, 129010
        • Investigational site #54
      • Saratov, Russian Federation, 410018
        • Investigational site #56
      • St. Petersburg, Russian Federation, 192283
        • Investigational site #63
      • St. Petersburg, Russian Federation, 194291
        • Investigational site #67
      • St. Petersburg, Russian Federation, 194354
        • Investigational site #53
      • St. Petersburg, Russian Federation, 194354
        • Investigational site #66
      • St. Petersburg, Russian Federation, 195267
        • Investigational site #59
      • St. Petersburg, Russian Federation, 197110
        • Investigational site #65
      • St. Petersburg, Russian Federation, 197198
        • Investigational site #55
      • St. Petersburg, Russian Federation, 198134
        • Investigational site #58
      • St. Petersburg, Russian Federation, 199178
        • Investigational site #64
  • Sweden
      • Dalby, Sweden, SE-240 10
        • Investigational Site #12
      • Gothenburg, Sweden, SE-411 36
        • Investigational Site #11
      • Malmo, Sweden, SE-205 02
        • Investigational Site #13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline weight
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theracos

Collaborators

TFS Trial Form Support

Investigators

  • Study Director: Natalie J Warner, MD, Theracos, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-4109-C-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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