A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
Primary Purpose
Obesity
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TM30339 and/or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
AM dose: 0.85 mg PM dose: placebo
AM dose: 0.85 mg PM dose: 0.85 mg
AM dose: 2.55 mg PM dose: placebo
AM dose: placebo PM dose: 2.55 mg
AM dose: 2.55 mg PM dose: 2.55 mg
AM dose: placebo PM dose: placebo
Outcomes
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.
Secondary Outcome Measures
To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio
To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index
To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00746824
Brief Title
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The IND was withdrawn.
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
7TM Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AM dose: 0.85 mg
PM dose: placebo
Arm Title
2
Arm Type
Experimental
Arm Description
AM dose: 0.85 mg
PM dose: 0.85 mg
Arm Title
3
Arm Type
Experimental
Arm Description
AM dose: 2.55 mg
PM dose: placebo
Arm Title
4
Arm Type
Experimental
Arm Description
AM dose: placebo
PM dose: 2.55 mg
Arm Title
5
Arm Type
Experimental
Arm Description
AM dose: 2.55 mg
PM dose: 2.55 mg
Arm Title
6
Arm Type
Experimental
Arm Description
AM dose: placebo
PM dose: placebo
Intervention Type
Drug
Intervention Name(s)
TM30339 and/or placebo
Other Intervention Name(s)
30339
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability
Time Frame
Visit 5 (the 29th day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
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A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
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