Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss

This study has been completed.
Sponsor:
Information provided by:
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT00779519
First received: October 23, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

Multiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and body weight.

It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in treating obesity.


Condition Intervention Phase
Obesity
Drug: TTP435
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study to Assess Safety and Tolerability of TTP435 in Obese (Class 1-2) Subjects Over 8 Weeks of Treatment

Resource links provided by NLM:


Further study details as provided by TransTech Pharma:

Primary Outcome Measures:
  • Participant Adverse Events [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline Glucose Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Absolute Change in Body Weight [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Absolute Change in Body Mass Index [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Effect Subject-reported Satiety [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Change from Baseline Insulin Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Change from Baseline Free Fatty Acid Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]
  • Change from Baseline Leptin Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: TTP435 Drug: TTP435

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers, aged 18 to 65 years, inclusive.
  • Subjects must be obese (class 1: BMI of 30.0 to 34.9 kg/m2 or class 2: BMI of 35 to 39.9 kg/m2 in non-Asians and BMI of 27.0 - 31.9 kg/m2 or 32.0 - 36.9 kg/m2 in Asians) at the Screening Visit.
  • Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to scheduled dosing and confirmatory FSH test in the range of 23-116 IU/L) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to Screening Visit or of a hysterectomy and/or bilateral oophorectomy) and agree not to undergo in vitro fertilization during the study and for 6 months post treatment.

Exclusion Criteria:

  • Type 1 diabetes.
  • Type 2 diabetes.
  • History of myocardial infarction, stroke, including transient ischemic attack, in the last 2 years.
  • Asthma or chronic obstructive pulmonary disease controlled by regular use of inhaled steroids.
  • Subjects with rheumatoid arthritis, lupus, or multiple sclerosis regularly requiring steroids or disease-modifying anti-rheumatic agents.
  • Subjects with psoriasis requiring oral steroids.
  • Subjects planning to undergo gastric bypass or resection surgery, or who have had such a procedure in the 6 months prior to the Screening Visit.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779519

Locations
United States, California
Los Angeles, California, United States, 90095
San Diego, California, United States, 92130
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Illinois
Springfield, Illinois, United States, 26704
United States, Nevada
Reno, Nevada, United States, 89502
United States, New York
New York, New York, United States, 10065
United States, North Carolina
Charlotte, North Carolina, United States, 28277
United States, Virginia
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K 5R3
Canada, Ontario
Oakville, Ontario, Canada, L6H 3P1
Toronto, Ontario, Canada
Sponsors and Collaborators
TransTech Pharma
Investigators
Study Chair: James Wamsley, MD TransTech Pharma
  More Information

No publications provided

Responsible Party: Jane Shen, Pharm.D., TransTech Pharma
ClinicalTrials.gov Identifier: NCT00779519     History of Changes
Other Study ID Numbers: TTP435-201
Study First Received: October 23, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by TransTech Pharma:
Obesity
Class 1
Class 2
Weight Loss
AgRP
TTP435
alphaMSH
Agouti-Related Protein
alpha-melanocyte stimulating hormone

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

ClinicalTrials.gov processed this record on October 22, 2014