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

Sponsor:	7TM Pharma A/S
Information provided by:	7TM Pharma A/S
ClinicalTrials.gov Identifier:	NCT00746824

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: TM30339 and/or placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Control

U.S. FDA Resources

Further study details as provided by 7TM Pharma A/S:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	192
Study Start Date:	August 2008
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AM dose: 0.85 mg PM dose: placebo	Drug: TM30339 and/or placebo 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. Other Name: 30339
Experimental: 2 AM dose: 0.85 mg PM dose: 0.85 mg	Drug: TM30339 and/or placebo 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. Other Name: 30339
Experimental: 3 AM dose: 2.55 mg PM dose: placebo	Drug: TM30339 and/or placebo 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. Other Name: 30339
Experimental: 4 AM dose: placebo PM dose: 2.55 mg	Drug: TM30339 and/or placebo 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. Other Name: 30339
Experimental: 5 AM dose: 2.55 mg PM dose: 2.55 mg	Drug: TM30339 and/or placebo 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. Other Name: 30339
Experimental: 6 AM dose: placebo PM dose: placebo	Drug: TM30339 and/or placebo 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. Other Name: 30339

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746824

Locations

United States, California
National Research Institute (NRI)
Los Angeles, California, United States, 90057
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34203
University Clinical Research DeLand, LLC
Deland, Florida, United States, 32720
Orlando Center for Clinical Research (OCRC)
Orlando, Florida, United States, 32809
United States, Kentucky
Central KY Research
Lexington, Kentucky, United States, 40509
United States, Tennessee
New Orleans Center for Clinical Research Knoxville (NOCCR)
Knoxville, Tennessee, United States, 37920
United States, Texas
DGD Research
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

7TM Pharma A/S

Investigators

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

More Information

Additional Information:

7TM Pharma website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Karsten Lundgren, PhD, Project Director, 7TM Pharma
ClinicalTrials.gov Identifier:	NCT00746824 History of Changes
Other Study ID Numbers:	2022
Study First Received:	August 27, 2008
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by 7TM Pharma A/S:

Obesity
weight loss
7TM Pharma
TM30339
Y4 receptor antagonist

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on February 12, 2012