NCT00485017

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2 obesity

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

June 8, 2007

Last Update Submit

September 27, 2019

Conditions

Obesity

Keywords

ObesityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline weight

    24 weeks

Secondary Outcomes (3)

  • 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

Study Arms (4)

1

EXPERIMENTAL

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

Drug: THR-4109

2

EXPERIMENTAL

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

Drug: THR-4109

3

EXPERIMENTAL

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

Drug: THR-4109

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

THR-4109DRUG

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

123
PlaceboDRUG

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

4

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Investigational Site #62

Arkhangelsk, 163045, Russia

Location

Investigational Site #61

Moscow, 107014, Russia

Location

Investigational Site #51

Moscow, 117036, Russia

Location

Investigational Site #60

Moscow, 121069, Russia

Location

Investigational Site #57

Moscow, 123056, Russia

Location

Investigational Site #50

Moscow, 125315, Russia

Location

Investigational Site #54

Moscow, 129010, Russia

Location

Investigational Site #63

Saint Petersburg, 192283, Russia

Location

Investigational Site #67

Saint Petersburg, 194291, Russia

Location

Investigational Site #53

Saint Petersburg, 194354, Russia

Location

Investigational Site #66

Saint Petersburg, 194354, Russia

Location

Investigational Site #59

Saint Petersburg, 195267, Russia

Location

Investigational Site #65

Saint Petersburg, 197110, Russia

Location

Investigational Site #55

Saint Petersburg, 197198, Russia

Location

Investigational Site #58

Saint Petersburg, 198134, Russia

Location

Investigational Site #64

Saint Petersburg, 199178, Russia

Location

Investigational Site #56

Saratov, 410018, Russia

Location

Investigational Site #12

Dalby, SE-240 10, Sweden

Location

Investigational Site #11

Gothenburg, SE-411 36, Sweden

Location

Investigational Site #13

Malmo, SE-205 02, Sweden

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Natalie J Warner, MD

    Theracos, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 12, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

SE(3)RU(17)