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

This study has been terminated.
(The IND was withdrawn.)
Sponsor:
Information provided by (Responsible Party):
7TM Pharma A/S
ClinicalTrials.gov Identifier:
NCT00746824
First received: August 27, 2008
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Obesity
Drug: TM30339 and/or placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by 7TM Pharma A/S:

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. [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability [ Time Frame: Visit 5 (the 29th day) ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 30339

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: 7TM Pharma A/S
ClinicalTrials.gov Identifier: NCT00746824     History of Changes
Other Study ID Numbers: 2022
Study First Received: August 27, 2008
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 7TM Pharma A/S:
Obesity
weight loss
7TM Pharma
TM30339
Y4 receptor antagonist

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014