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

NCT ID: NCT00746824

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Keywords

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Obesity weight loss 7TM Pharma TM30339 Y4 receptor antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

AM dose: 0.85 mg

PM dose: placebo

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

2

AM dose: 0.85 mg

PM dose: 0.85 mg

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

3

AM dose: 2.55 mg

PM dose: placebo

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

4

AM dose: placebo

PM dose: 2.55 mg

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

5

AM dose: 2.55 mg

PM dose: 2.55 mg

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

6

AM dose: placebo

PM dose: placebo

Group Type EXPERIMENTAL

TM30339 and/or placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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30339

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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7TM Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Related Links

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http://www.7tm.com

7TM Pharma website

Other Identifiers

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2022

Identifier Type: -

Identifier Source: org_study_id