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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779519
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : June 27, 2011
Information provided by:
vTv Therapeutics

Brief Summary:

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 or disease Intervention/treatment Phase
Obesity Drug: TTP435 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2009
Actual Primary Completion Date : December 2009

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: TTP435 Drug: TTP435

Primary Outcome Measures :
  1. Participant Adverse Events [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]

Secondary Outcome Measures :
  1. Change from Baseline Glucose Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  2. Absolute Change in Body Weight [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  3. Absolute Change in Body Mass Index [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  4. 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) ]
  5. Effect Subject-reported Satiety [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  6. Change from Baseline Insulin Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  7. Change from Baseline Free Fatty Acid Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]
  8. Change from Baseline Leptin Levels [ Time Frame: Day 1 to Day 70 (2 weeks post dose) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00779519

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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
vTv Therapeutics
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Study Chair: James Wamsley, MD vTv Therapeutics
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Responsible Party: Jane Shen, Pharm.D., TransTech Pharma Identifier: NCT00779519    
Other Study ID Numbers: TTP435-201
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Keywords provided by vTv Therapeutics:
Class 1
Class 2
Weight Loss
Agouti-Related Protein
alpha-melanocyte stimulating hormone
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms