A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals. - Tabular View

Tracking Information

First Received Date ^ICMJE

August 27, 2008

Last Updated Date

December 22, 2008

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00746824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: Yes ]
To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: Yes ]
To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339 [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: Yes ]
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.

Official Title ^ICMJE

TM30339: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel, Repeated Subcutaneous Dose-Range Study Designed to Determine the Weight Loss in Obese Subjects.

Brief Summary

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

Detailed Description

Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.

7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: TM30339 and/or placebo

Study Arms / Comparison Groups

Experimental:
AM dose: 0.85 mg

PM dose: placebo
Experimental:
AM dose: 0.85 mg

PM dose: 0.85 mg
Experimental:
AM dose: 2.55 mg

PM dose: placebo
Experimental:
AM dose: placebo

PM dose: 2.55 mg
Experimental:
AM dose: 2.55 mg

PM dose: 2.55 mg
Experimental:
AM dose: placebo

PM dose: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

March 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00746824

Responsible Party

Karsten Lundgren, PhD, Project Director, 7TM Pharma

Study ID Numbers ^ICMJE

2022

Study Sponsor ^ICMJE

7TM Pharma A/S

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	William B. Smith, MD, FACC	New Orleans Center for Clinical Research Knoxville
Principal Investigator:	Andrew J. Lewin, MD	National Research Institute (NRI)
Principal Investigator:	Tom C. Marbury, MD	Orlando Center for Clinical Research (OCRC)
Principal Investigator:	Bruce G. Rankin, DO, CPI	University Clinical Research DeLand, LLC
Principal Investigator:	Louis B. Chaykin, MD	Meridien Research
Principal Investigator:	James L. Borders, MD	Central KY Research
Principal Investigator:	Mark S. Kipnes, MD	DGD Research

Information Provided By

7TM Pharma A/S

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP