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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00746824
• Other study ID #: 2022
• Status: Terminated
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: August 31, 2012
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2012
• Source: 7TM Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive

2. Age 18-60 years inclusive

3. 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

4. Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject

Exclusion Criteria:

1. Subjects with a history of allergies toward products containing natural rubber (e.g. latex)

2. 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

3. Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes

4. Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening

5. Subjects with bradycardia (heart rate < 50)

6. Subjects with heart block

7. Clinically significant thyroid dysfunction as evidenced by TSH > 1.5 X ULN

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
7TM Pharma A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability		Visit 5 (the 29th day)	Yes