Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
NCT ID: NCT00748605
Last Updated: 2018-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
842 participants
INTERVENTIONAL
2007-06-30
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD compared with placebo in medically stable and otherwise healthy obese male and female subjects
3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD in obese male and female subjects
4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal during an initial 6-week LCD compared with placebo in medically stable and otherwise healthy obese male and female subjects
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
NCT00747929
One-Year Study of S1B-509 vs Placebo for Weight Loss
NCT06517797
Safety and Efficacy Study of S-309309 in Obese Adults
NCT05925114
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
NCT05564117
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
NCT04010786
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
S-2367 placebo + LCD (Low Calorie Diet) +RCD (Reduced Calorie Diet)
S-2367 Placebo
Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks
LCD (low calorie diet)
A low calorie diet was utilized during the first 6 weeks of the study
RCD (reduced calorie diet)
A reduced calorie diet was used during the last 54 weeks for the study
S-2367 1600 mg q.d. 54 weeks
S-2367 placebo + LCD for 6 weeks and 1600 mg S-2367 + RCD for 54 weeks
S-2367 Placebo
Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks
S-2367 1600 mg q.d. 54 Weeks
Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks
LCD (low calorie diet)
A low calorie diet was utilized during the first 6 weeks of the study
RCD (reduced calorie diet)
A reduced calorie diet was used during the last 54 weeks for the study
S-2367 1600 mg q.d. 60 weeks
S-23671600 mg q.d. + LCD for 6 weeks and S-2367 1600 mg q.d + RCD for 54 weeks
S-2367 1600 mg q.d. 60 weeks
Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks
LCD (low calorie diet)
A low calorie diet was utilized during the first 6 weeks of the study
RCD (reduced calorie diet)
A reduced calorie diet was used during the last 54 weeks for the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
S-2367 Placebo
Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks
S-2367 1600 mg q.d. 54 Weeks
Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks
S-2367 1600 mg q.d. 60 weeks
Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks
LCD (low calorie diet)
A low calorie diet was utilized during the first 6 weeks of the study
RCD (reduced calorie diet)
A reduced calorie diet was used during the last 54 weeks for the study
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 (ECGs), 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
Exclusion Criteria
* 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 within 1 year prior to Visit 1
* Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 3 months prior to Visit 1
* Previous use or participation in a study of S-2367 or any other neuropeptide Y5 agonist or antagonist
* Participation in any weight loss medication/product study in which receipt of weight loss medication/product occurred within 3 months prior to Visit 1
* Use of any prescription or non-prescription over-the-counter (OTC) medication/product or herbal/phytotherapeutic/plant-derived medications/products within 3 months prior to Visit 1 that is intended to induce weight loss, appetite suppression, weight control, or treat obesity
* Use of chronic medications/products within 3 months prior to Visit 1 or during the study that are known to cause weight gain. The list includes but is not limited to amitriptyline (Elavil), paroxetine (Paxil), setraline (Zoloft), and mirtazepine (Remeron)
* Use of any prescription or non-prescription OTC medications/products within 1 month prior to Visit 1, unless deemed acceptable by the investigator.
* Donation of blood or blood products 3 months prior to Visit 1 or during the entire study
* Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to complete and/ or participate in this clinical study
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shionogi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Fountain Valley, California, United States
San Diego, California, United States
San Francisco, California, United States
Waterbury, Connecticut, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
South Dartmouth, Massachusetts, United States
Brooklyn Center, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Edison, New Jersey, United States
Endwell, New York, United States
Burlington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Yukon, Oklahoma, United States
Bensalem, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
West Jordan, Utah, United States
Wauwatosa, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0702A2824 revised
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.