NCT00746824

Brief Summary

The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2 obesity

Status
terminated

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

Study Start

First participant enrolled

August 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

August 27, 2008

Last Update Submit

August 31, 2012

Conditions

Obesity

Keywords

Obesityweight loss7TM PharmaTM30339Y4 receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.

    Visit 5 (the 29th day)

Secondary Outcomes (4)

  • To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio

    Visit 5 (the 29th day)

  • To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index

    Visit 5 (the 29th day)

  • To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339

    Visit 5 (the 29th day)

  • To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability

    Visit 5 (the 29th day)

Study Arms (6)

1

EXPERIMENTAL

AM dose: 0.85 mg PM dose: placebo

Drug: TM30339 and/or placebo

2

EXPERIMENTAL

AM dose: 0.85 mg PM dose: 0.85 mg

Drug: TM30339 and/or placebo

3

EXPERIMENTAL

AM dose: 2.55 mg PM dose: placebo

Drug: TM30339 and/or placebo

4

EXPERIMENTAL

AM dose: placebo PM dose: 2.55 mg

Drug: TM30339 and/or placebo

5

EXPERIMENTAL

AM dose: 2.55 mg PM dose: 2.55 mg

Drug: TM30339 and/or placebo

6

EXPERIMENTAL

AM dose: placebo PM dose: placebo

Drug: TM30339 and/or placebo

Interventions

TM30339 and/or placeboDRUG

The drug and/or placebo will be injected in the abdominal area (site to vary for each injection). Injections will be administered twice daily for 28 days.

Also known as: 30339
123456

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
  • Age 18-60 years inclusive
  • Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
  • Stable weight over past 2 months i.e. a change in body weight \< 3 kg as reported by the subject

You may not qualify if:

  • Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
  • Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
  • Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
  • Subjects who have a QTc (Bazett's correction) interval of \> 450 msec at screening
  • Subjects with bradycardia (heart rate \< 50)
  • Subjects with heart block
  • Clinically significant thyroid dysfunction as evidenced by TSH \> 1.5 X ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2008

First Posted

September 4, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 3, 2012

Record last verified: 2012-08