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(The IND was withdrawn.)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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More 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 August 20, 2014