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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: TTP435

• Registration Number: NCT00779519
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2009-02
• Primary Completion: 2009-12
• Disposition First Submitted: 2010-07-15
• Disposition First Submitted QC: 2010-07-20
• Disposition First Posted: 2010-07-22
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TTP435	TTP435	-

Primary Outcome Measures

Name	Time	Method
Participant Adverse Events	Day 1 to Day 70 (2 weeks post dose)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Glucose Levels	Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Weight	Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Mass Index	Day 1 to Day 70 (2 weeks post dose)
Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo	Day 1 to Day 70 (2 weeks post dose)
Effect Subject-reported Satiety	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Insulin Levels	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Free Fatty Acid Levels	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Leptin Levels	Day 1 to Day 70 (2 weeks post dose)