Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet

NCT00747929 | Completed Phase 2

• 1 other identifier: 0701A2823
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 38

Brief Summary

1. 1.To evaluate the effect of S-2367 on body weight when administered following a 6-week placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet compared to placebo in healthy obese male and female subjects
2. 2.To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure
3. 3.To evaluate the steady-state/trough pharmacokinetics of S-2367

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• The change in body weight over the 54-week active therapy phase of the study

  body weight at 54 weeks compared to body weight at start of treatment

  54 weeks

Secondary Outcomes (3)

• Change in body composition: calculated body mass index, waist circumference, hip circumference, and calculated waist-to-hip ratio

  54 weeks

• Steady-state/trough pharmacokinetic analysis

  After 3, 12, 24, 36, and 54 weeks

• Safety and tolerability of S-2367

  54 weeks

Study Arms (3)

S-2367 Placebo

PLACEBO COMPARATOR

Placebo + reduced calorie diet

Drug: S-2367 Placebo; Other: Reduced Calorie Diet

S-2367 800 mg

EXPERIMENTAL

S-2367 800 mg q.d. + reduced calorie diet

Drug: S-2367 800 mg; Other: Reduced Calorie Diet

S-2367 1600 mg

EXPERIMENTAL

S-2367 1600 mg q.d. + reduced calorie diet

Drug: S-2367 1600 mg; Other: Reduced Calorie Diet

Interventions

S-2367 Placebo DRUG

four placebo tablets (total dose = 0 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks,

S-2367 Placebo

S-2367 800 mg DRUG

two 400 mg S-2367 tablets (total dose = 800 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks

Also known as: Velneperit

S-2367 800 mg

S-2367 1600 mg DRUG

four 400 mg S-2367 tablets (total dose = 1600 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for total of 54 weeks,

Also known as: Velneperit

S-2367 1600 mg

Reduced Calorie Diet OTHER

A diet with restricted calorie content

S-2367 1600 mg; S-2367 800 mg; S-2367 Placebo

Eligibility Criteria

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

You may qualify if:

• Males and females between 18 and 65 years of age and body mass index between 30.0 to 45.0 kg/m2, inclusive, and a weight that has not fluctuated by more than 3% for the last 3 months
• Medically stable for 3 months prior to Visit 1 and in otherwise good health, with no clinically significant findings from medical history, physical examination, 12-lead electrocardiograms (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, Homeostatic Model Assessment of Insulin Sensitivity Index, hemoglobin A1c, thyroid stimulating hormone, free thyroxine, cortisol, iron, and ferritin) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator
• Males will be sterile or agree 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 1) 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 1 and during study) oral, implantable, transdermal, or injectable oral 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 1, or agree to use an approved method of contraception. Some of the approved methods of contraception for females include a sterile (for at least 3 months prior to Visit 1) male sexual partner; use of oral, implantable, transdermal, or injectable oral 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
• History or presence of an abnormal ECG, which in the investigator's opinion, is clinically significant
• History or 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 dose and form has remained stable for at least the previous 3 months and 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
• History or evidence of an eating disorder with a compensatory behavior such as "purging bulimia nervosa" or "non-purging bulimia nervosa"
• History of obesity of endocrine origin
• History of type 1 or type 2 diabetes mellitus
• Clinically significant hypertension defined as blood pressure \> 160/90 mm Hg for either the systolic or diastolic values in either the untreated or treated state
• Clinically significant GI history or surgery. NOTE: Appendectomy and cholecystectomy will be allowed
• Gastric bypass surgery, stomach banding surgery, or any other surgical procedure(s) that attempt to promote/aid weight loss
• History of polycystic ovarian syndrome
• History of fenfluramine or dexfenfluramine or "fen-phen" administration with abnormal findings on echocardiograms at the time of "fen-phen" discontinuation
• History of participation in any weight loss program within 3 months prior to Visit 1
• History of body weight loss or gain greater than 3% within 3 months prior to Visit 1
• History of alcoholism or drug addiction/ substance abuse within 1 year prior to Visit 1
• History of any tobacco-containing or nicotine-containing product use (including cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 1 year prior to Visit 1

Sponsors & Collaborators

• Shionogi: lead

Study Sites (38)

Unknown Facility

Mobile, Alabama, 36608, 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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Roseville, California, 95661, United States

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Sacramento, California, 95816, United States

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Stamford, Connecticut, 06905, 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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Stuart, Florida, 34996, United States

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Atlanta, Georgia, 30328, United States

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Chicago, Illinois, 60607, 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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Milford, Massachusetts, 01757, United States

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Gulfport, Mississippi, 39501, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Berlin, New Jersey, 08009, 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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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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Cleveland, Ohio, 44122, United States

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Mogadore, Ohio, 44260, 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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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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Houston, Texas, 77024, United States

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Jackson, Texas, 77566, United States

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San Antonio, Texas, 78229, 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

Location

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2009
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (38)