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

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

Patrocinadores

Patrocinador principal: vTv Therapeutics

Fuente vTv Therapeutics
Resumen breve

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.

Estado general Completed
Fecha de inicio February 2009
Fecha de finalización primaria December 2009
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Participant Adverse Events Day 1 to Day 70 (2 weeks post dose)
Resultado secundario
Medida Periodo de tiempo
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)
Inscripción 100
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: TTP435

Etiqueta de grupo de brazo: TTP435

Tipo de intervención: Drug

Nombre de intervención: Placebo

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: 65 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
James Wamsley, MD Study Chair vTv Therapeutics
Ubicación
Instalaciones:
| Los Angeles, California, 90095, United States
| San Diego, California, 92130, United States
| Augusta, Georgia, 30909, United States
| Springfield, Illinois, 26704, United States
| Reno, Nevada, 89502, United States
| New York, New York, 10065, United States
| Charlotte, North Carolina, 28277, United States
| Norfolk, Virginia, 23502, United States
| Richmond, Virginia, 23294, United States
| Halifax, Nova Scotia, B3K 5R3, Canada
| Oakville, Ontario, L6H 3P1, Canada
| Toronto, Ontario, Canada
Ubicacion Paises

Canada

United States

Fecha de verificación

June 2011

Fiesta responsable

Nombre Titulo: Jane Shen, Pharm.D.

Organización: TransTech Pharma

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Placebo

Tipo: Placebo Comparator

Etiqueta: TTP435

Tipo: Experimental

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov