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

TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.

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

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: TM30339 and/or placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; AM dose: 0.85 mg PM dose: placebo	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.; Other Names: 30339
EXPERIMENTAL: 2; AM dose: 0.85 mg PM dose: 0.85 mg	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.; Other Names: 30339
EXPERIMENTAL: 3; AM dose: 2.55 mg PM dose: placebo	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.; Other Names: 30339
EXPERIMENTAL: 4; AM dose: placebo PM dose: 2.55 mg	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.; Other Names: 30339
EXPERIMENTAL: 5; AM dose: 2.55 mg PM dose: 2.55 mg	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.; Other Names: 30339
EXPERIMENTAL: 6; AM dose: placebo PM dose: placebo	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.; Other Names: 30339

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability	Visit 5 (the 29th day)

Collaborators and Investigators

• Sponsor: 7TM Pharma A/S

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (ESTIMATE): September 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; weight loss; 7TM Pharma; TM30339; Y4 receptor antagonist
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2022