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

Sponsor

vTv Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00779519

Collaborator

(none)

100

Enrollment

Locations

Arms

8.3

Patients Per Site

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Experimental: TTP435

Drug: TTP435

Outcome Measures

Primary Outcome Measures

Participant Adverse Events [Day 1 to Day 70 (2 weeks post dose)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Los Angeles	California	United States	90095
2	San Diego	California	United States	92130
3	Augusta	Georgia	United States	30909
4	Springfield	Illinois	United States	26704
5	Reno	Nevada	United States	89502
6	New York	New York	United States	10065
7	Charlotte	North Carolina	United States	28277
8	Norfolk	Virginia	United States	23502
9	Richmond	Virginia	United States	23294
10	Halifax	Nova Scotia	Canada	B3K 5R3
11	Oakville	Ontario	Canada	L6H 3P1
12	Toronto	Ontario	Canada