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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

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Label

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

NCT ID

NCT00746824

First Posted

August 27, 2008

Last Updated

August 31, 2012

Sponsor

7TM Pharma A/S

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

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

Arm Type

Experimental

Arm Description

AM dose: 0.85 mg PM dose: placebo

Arm Title

Arm Type

Experimental

Arm Description

AM dose: 0.85 mg PM dose: 0.85 mg

Arm Title

Arm Type

Experimental

Arm Description

AM dose: 2.55 mg PM dose: placebo

Arm Title

Arm Type

Experimental

Arm Description

AM dose: placebo PM dose: 2.55 mg

Arm Title

Arm Type

Experimental

Arm Description

AM dose: 2.55 mg PM dose: 2.55 mg

Arm Title

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

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

Learn more about this trial

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

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