Clinical trial NCT00779519: Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Class 1
Class 2
Weight Loss
AgRP
TTP435
alphaMSH
Agouti-Related Protein
alpha-melanocyte stimulating hormone
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Participant Adverse Events
timeFrame: Day 1 to Day 70 (2 weeks post dose)
Secondary outcomes:
measure: Change from Baseline Glucose Levels
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Absolute Change in Body Weight
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Absolute Change in Body Mass Index
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Effect Subject-reported Satiety
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Change from Baseline Insulin Levels
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Change from Baseline Free Fatty Acid Levels
timeFrame: Day 1 to Day 70 (2 weeks post dose)
measure: Change from Baseline Leptin Levels
timeFrame: Day 1 to Day 70 (2 weeks post dose)
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Augusta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Reno
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Halifax
country: Canada
state: Nova Scotia
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: vTv Therapeutics
name: James Wamsley, MD
role: STUDY_CHAIR
References: