Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese Subjects

NCT00788528 | Completed Phase 2

• 1 other identifier: 0813A2825
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 73

Brief Summary

The purpose of this open-label extension study is to evaluate the safety and efficacy of velneperit (S-2367) in obese subjects.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (2)

• Efficacy assessment: The change in body weight over the 54-week active therapy phase of the study is the primary efficacy variable

  54 weeks

• Treatment-emergent adverse events are summarized by system/organ class and preferred term using MedDRA. Safety assessments included clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, physical examination, and reported adverse events

  From the first dose of OLE study drug at Visit 20 until 30 days after the last dose of study drug

Secondary Outcomes (2)

• Efficacy assessment: Secondary efficacy variables included analyses of body weight, body mass index, waist circumference, metabolic indexes, psychological variables, and dosage

  Over the 54-week active therapy phase of the OLE study

• Pharmacokinetic assessment: Pharmacokinetic trough levels were calculated based on the plasma concentrations. The data were analyzed at each interval and across intervals. Trough levels were correlated with dose, if appropriate

  Weeks 3, 24, and 54

Study Arms (1)

Arm A

EXPERIMENTAL

1600 mg S-2367 (velneperit)

Drug: S-2367 (velneperit)

Interventions

S-2367 (velneperit) DRUG

Tablet, 4 x 400 mg, taken once daily with morning meal, 54-weeks

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have completed all randomized treatment visits in the reduced calorie diet (RCD, Shionogi protocol 0701A2823) or low calorie diet (LCD, Shionogi protocol 0702A2824) study up to and including Visit 13
• Medically stable throughout the controlled clinical trial treatment period and in otherwise good health, with no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs
• Clinical laboratory evaluations (including clinical chemistry \[fasted at least 8 hours\], complete blood count, urinalysis, including creatine phosphokinase, amylase, lipase, lipid profile, insulin and Homeostatic Model Assessment of Insulin Sensitivity Index within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
• Males will be sterile or agree to continue to use an approved method of contraception. Some of the approved methods of contraception for males includes a surgically sterile (for at least 3 months prior to Visit 13/20) female sexual partner; a postmenopausal (for at least 1 year since last menstrual cycle) female sexual partner; a female sexual partner who uses (for at least previous 3 months prior to Visit 13/20 and during study) oral, implantable, transdermal, or injectable contraceptives; or use of the following double-barrier method: male condom with spermicide
• Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year since last menstrual period, surgically sterile for at least 3 months prior to Visit 13/20, or agree to use an approved method of contraception. Some of the approved methods of contraception for females includes a sterile (for at least 3 months prior to Visit 13/20) male sexual partner; use of oral, implantable, transdermal, or injectable contraceptives; or use of one of the following double-barrier methods: intrauterine device with spermicide, diaphragm with spermicide, cervical cap with spermicide, female condom with spermicide, or a male condom with spermicide by the male sexual partner
• Able to understand and willing to sign an informed consent form and comply with all study procedures

You may not qualify if:

• History or clinical manifestations of significant metabolic, hepatic, immunological (e.g., human immunodeficiency virus/acquired immunodeficiency syndrome), renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), urological, neurological or psychiatric disorders
• Current abnormal ECG, which, in the Investigator's opinion, is clinically significant
• Current evidence of a psychological disorder, other than stable or controlled anxiety or depression including, but not limited to the schizophrenias. Treatment with an antidepressant or anxiolytic drug(s) will be permitted if the medication is not precluded / excluded by this protocol because of potential effects on body weight and is not expected to change during the remainder of this clinical protocol
• A score above 10 in either the Anxiety or Depression portions of the Hospital Anxiety and Depression Scale (HADS) at Visit 13/20. Subjects whose HADS score at Visit 13/20 exceeds 10 in either the Anxiety or Depression portions of the HADS will be allowed in the study only after they are examined and it is determined that the symptoms of anxiety and/or depression are not of a severity that is incompatible with further treatment with velneperit. Permission must also be obtained from the Sponsor or Sponsor's designated medical representative for subjects with scores above 10 on these HADS subscores
• Current obesity of endocrine origin
• Current Type 1 or Type 2 diabetes mellitus
• Current clinically significant hypertension, defined as blood pressure \>160/90 mmHg for either the systolic or diastolic values in either the untreated or treated state
• Current or planned clinically significant GI surgery. Note: Appendectomy and cholecystectomy will be allowed
• Current or planned gastric bypass surgery, stomach banding surgery, or any other surgical procedure(s) that attempt to promote/aid weight loss. Note: Liposuction will be allowed if done more than 3 months prior to Study Visit 20
• Current polycystic ovarian syndrome
• Current or planned participation in any weight loss program outside of the program described in this open-label extension (OLE) study
• Current alcoholism or drug addiction/substance abuse. Note: Alcohol use during the study is allowed provided "routine" daily consumption is less than or equal to 2 units/day (1 unit is the equivalent of 12 oz. of beer, 5 oz. of wine, or 1.5 oz. of 80-proof distilled spirits \[or equivalent\]) and except that no alcohol consumption is allowed within 48 hours prior to blood collections for analysis of lipid profiles
• Current use of any tobacco-containing or nicotine-containing product (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum
• Current or planned participation in any other investigational study drug trial in which receipt of investigational study drug will occur
• Current or planned participation in any weight loss medication/product study in which receipt of weight loss medication/product will occur

Sponsors & Collaborators

• Shionogi: lead

Study Sites (73)

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Birmingham, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85014, United States

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Tucson, Arizona, 85701, United States

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Hot Springs, Arkansas, 71913, United States

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Carmichael, California, 95608, United States

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Fountain Valley, California, 92708, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92108, United States

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San Francisco, California, 94102, United States

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Stamford, Connecticut, 06905, United States

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Waterbury, Connecticut, 06708, United States

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Coral Gables, Florida, 33134, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32259, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32809, United States

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Stuart, Florida, 34996, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30338, United States

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Augusta, Georgia, 30909, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60654, United States

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Gurnee, Illinois, 60031, United States

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Springfield, Illinois, 62704, United States

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Evansville, Indiana, 47714, United States

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Shawnee Mission, Kansas, 66218, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Boston, Massachusetts, 02135, United States

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Milford, Massachusetts, 01757, United States

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South Dartmouth, Massachusetts, 02747, United States

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Brooklyn Center, Minnesota, 55430, United States

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Gulfport, Mississippi, 39501, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89146, United States

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Berlin, New Jersey, 08009, United States

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Edison, New Jersey, 08817, United States

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Endwell, New York, 13760, United States

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Manlius, New York, 13104, United States

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Rochester, New York, 14609, United States

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Burlington, North Carolina, 27215, United States

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Concord, North Carolina, 28025, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43212, United States

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Mogadore, Ohio, 44260, United States

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Yukon, Oklahoma, 73099, United States

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Bensalem, Pennsylvania, 19020, United States

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Cranston, Rhode Island, 02920, United States

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Greenville, South Carolina, 29615, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Bristol, Tennessee, 37620, United States

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Burns, Tennessee, 37029, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37203, United States

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Houston, Texas, 77024, United States

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Jackson, Texas, 77566, United States

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New Braunfels, Texas, 78130, United States

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San Antonio, Texas, 78229, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23294, United States

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Renton, Washington, 98057, United States

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Green Bay, Wisconsin, 54303, United States

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Wauwatosa, Wisconsin, 53226, United States

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 11, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (73)