Safety and Efficacy of Low Doses of V24343 in Obese Subjects - Full Text View

Purpose

Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo to study the effect of V24343 on blood pressure and weight in obese subjects.

The primary variables, change in blood pressure (BP) and pulse, will be assessed both by outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.

The efficacy of V24343 will be assessed by measurement of body weight, waist circumference, bioimpedance assessment of body composition and blood glucose.

Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing will be used to assess the pharmacokinetics of V24343.

Other safety assessments comprise routine monitoring of adverse events; concomitant medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and self-completed psychiatric assessments.

Condition	Intervention	Phase
Obesity	Drug: V24343	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	A Double-blind, Placebo-controlled, Parallel Group Study of the Effect of V24343 on Blood Pressure and Weight in Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Vernalis (R&D) Ltd:

Primary Outcome Measures:

To examine any effects of V24343 on pulse and blood pressure (vital signs) [ Time Frame: 24-hour on screening and pre-dose on Days 2, 26 and 56. Semi -recumbent and stand SBP , DBP and pulse, in duplicate at each time point. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine if there is adequate differentiation between doses of V24343 associated with any effect on vital signs and those associated with efficacy (weight loss). [ Time Frame: Body weight and wasit circumference: screen and time-matched to pre-dose on Days -1, 8, 15, 22, 29, 35, 42, 49 and 56. ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	October 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Randomised to a parallel group comparison of either one of four doses of study drug (1mg, 2mg, 5mg, 25mg) or placebo. Dosed once daily for 28 days	Drug: V24343 Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: Subjects must:

be healthy male subjects aged 18 to 60 years
have a body mass index greater than or equal to 27 kg/m2
have a waist measurement >94 cm
have blood pressure (BP) within the ranges systolic BP (SBP): 90-150 mmHg; diastolic BP (DBP): 40-90 mmHg, based on mean of day time readings recorded during a 24 hour period of ambulatory monitoring:
be willing to use an effective method of contraception (condom with a spermicidal contraceptive, or sterilised) for the duration of the study and for 3 months after the last dose of study medication
have an acceptable medical and social history in the 12 months prior to screening
be able to comply with the requirements of the entire study
give written informed consent

Exclusion Criteria: Subjects must not:

have received V24343 previously
suffer from or have a history of anxiety or depression; have abnormal results on Patient Health Questionnaire 9 or Profile of Mood States (see Section 6.3.4.5)
have a history of seizures (excluding febrile convulsions below 3 years of age)
be male subjects whose female partners are trying to become pregnant within 3 months after the last dose of study medication
have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
have multiple drug allergies or be allergic to any of the components of V24343 study medication
be smokers whom smoke more than 10 cigarettes per day
consume more than 28 units of alcohol per week, or have a significant history of alcohol abuse
have a positive test for alcohol or drugs of abuse at screening or admission to any of the treatment periods
have donated blood or plasma in excess of 500 mL within 3 months of screening
have been exposed to any new investigational agent within 3 months prior to study drug administration
have clinically significant abnormalities on laboratory screening tests, particularly liver function and renal function tests (see Section 6.3.4.2)
have clinically relevant abnormal physical findings on examination
have clinically relevant abnormal findings on 12-lead ECG including a mean QTcB at screening ≥430 msec
be seropositive for hepatitis B, hepatitis C or human immunodeficiency (HIV) viruses at screening
have any medical or social reasons for not participating in the study raised by their General Practitioner/primary care physician
have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
have had treatment with any prescription medicine within one month of first dose or any over-the-counter medicines, except for paracetamol, within one week of the first dose

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734201

Locations

United Kingdom
Hammersmith Medicines Research
London, United Kingdom, NW10 7NS

Sponsors and Collaborators

Vernalis (R&D) Ltd

Investigators

Principal Investigator:

Steve Warrington

Medical Director

More Information

No publications provided

Responsible Party:	Steve Warrington, Medical Director, Hammersmith Medicines Research,
ClinicalTrials.gov Identifier:	NCT00734201 History of Changes
Other Study ID Numbers:	V24343-1Ob-03
Study First Received:	August 6, 2008
Last Updated:	July 21, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vernalis (R&D) Ltd:

Study effects on blood pressure and weight in obese subjects

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013