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

NCT ID: NCT00779519

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TTP435

Group Type EXPERIMENTAL

TTP435

Intervention Type DRUG

Interventions

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TTP435

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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vTv Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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TransTech Pharma

Principal Investigators

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James Wamsley, MD

Role: STUDY_CHAIR

vTv Therapeutics

Locations

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Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

Augusta, Georgia, United States

Site Status

Springfield, Illinois, United States

Site Status

Reno, Nevada, United States

Site Status

New York, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Norfolk, Virginia, United States

Site Status

Richmond, Virginia, United States

Site Status

Halifax, Nova Scotia, Canada

Site Status

Oakville, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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TTP435-201

Identifier Type: -

Identifier Source: org_study_id

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