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

7TM Pharma

Status and phase: Terminated; Phase 2

Conditions: Obesity

Treatments: Drug: TM30339 and/or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746824

2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 6 patient groups

1

Experimental group

Description:

AM dose: 0.85 mg PM dose: placebo

Treatment:

Drug: TM30339 and/or placebo

2

Experimental group

Description:

AM dose: 0.85 mg PM dose: 0.85 mg

Treatment:

Drug: TM30339 and/or placebo

3

Experimental group

Description:

AM dose: 2.55 mg PM dose: placebo

Treatment:

Drug: TM30339 and/or placebo

4

Experimental group

Description:

AM dose: placebo PM dose: 2.55 mg

Treatment:

Drug: TM30339 and/or placebo

5

Experimental group

Description:

AM dose: 2.55 mg PM dose: 2.55 mg

Treatment:

Drug: TM30339 and/or placebo

6

Experimental group

Description:

AM dose: placebo PM dose: placebo

Treatment:

Drug: TM30339 and/or placebo