ObesityPhase 2NCT00747929
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
A Phase 2 study testing S-2367 800 mg, S-2367 1600 mg and Reduced Calorie Diet in people with Obesity, run by Shionogi at 38 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- S-2367 800 mg, S-2367 1600 mg and Reduced Calorie Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 724 participants
- Where
- 38 sitesUnited States
- Study dates
- Jun 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- 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, including, but not limited to, phentermine, sibutramine, orlistat, ephedra, rimonabant and other anorexogenics and/or stimulants, as well as topiramate
- 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. Some examples of allowed medications are stable use (over the 3-month period prior to Visit 1) of the following will be allowed: hormone replacement therapy (e.g., for postmenopausal women); antihypertensive agents (e.g., for hypertensive subjects); statins (e.g., for hyperlilidaemia); thyroid replacement therapy (e.g., for thyroid subjects and provided thyroid replacement therapy has been stable for 3 months and no clinically significant changes in thyroid stimulating hormone and/or free thyroxine occur[s] during the study); oral, implantable, transdermal, or injectable contraceptive(s), etc. Anticholinergics (if used acutely), centrally acting antihistamines, and anti-inflammatories will be also allowed. Continued, stable, moderate use (over 3 month period prior to Visit 1) of vitamins and minerals is allowed and additional use of multivitamin-mineral supplements (non-herbal) may be allowed by the investigator (or designee) as part of the study diet program
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Study site
Atlanta, Georgia, 30328
Study site
Berlin, New Jersey, 08009
Study site
Bristol, Tennessee, 37620
Study site
Burns, Tennessee, 37029
Study site
Carmichael, California, 95608
Study site
Chicago, Illinois, 60607
Study site
Cleveland, Ohio, 44122
Study site
Concord, North Carolina, 28025
Study site
Coral Gables, Florida, 33134
Study site
Cranston, Rhode Island, 02920
Study site
Evansville, Indiana, 47714
Study site
Green Bay, Wisconsin, 54303
Study site
Greenville, South Carolina, 29615
Study site
Gulfport, Mississippi, 39501
Study site
Hot Springs, Arkansas, 71913
Study site
Houston, Texas, 77024
Study site
Jackson, Texas, 77566
Study site
Jacksonville, Florida, 32216
Study site
Knoxville, Tennessee, 37920
Study site
Manlius, New York, 13104
Study site
Milford, Massachusetts, 01757
Study site
Mobile, Alabama, 36608
Study site
Mogadore, Ohio, 44260
Study site
Omaha, Nebraska, 68134
Study site
Raleigh, North Carolina, 27612
Study site
Renton, Washington, 98057
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14609
Study site
Roseville, California, 95661
Study site
Sacramento, California, 95816
Study site
Salisbury, North Carolina, 28144
Study site
San Antonio, Texas, 78229
Study site
Shawnee Mission, Kansas, 66218
Study site
Springfield, Illinois, 62704
Study site
St Louis, Missouri, 63141
Study site
Stamford, Connecticut, 06905
Study site
Stuart, Florida, 34996
Study site
Tucson, Arizona, 85701
About this study
Official title: A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0, 800, or 1600 mg/Day of S-2367 Administered Orally Once Daily With a Reduced Calorie Diet in Obese Males and Females
- 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
- To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure
- To evaluate the steady-state/trough pharmacokinetics of S-2367
- Conditions
- Obesity
- Being tested
- S-2367 Placebo, S-2367 800 mg, S-2367 1600 mg, Reduced Calorie Diet
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-2367 PlaceboDrug
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 800 mgDrug
Also called Velneperit
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
S-2367 1600 mgDrug
Also called Velneperit
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,
Reduced Calorie DietOther
A diet with restricted calorie content
| Study group | Role | What they receive |
|---|---|---|
| S-2367 Placebo | Placebo comparator | Placebo + reduced calorie diet Receives: Drug: S-2367 Placebo; Other: Reduced Calorie Diet |
| S-2367 800 mg | Experimental | S-2367 800 mg q.d. + reduced calorie diet Receives: Drug: S-2367 800 mg; Other: Reduced Calorie Diet |
| S-2367 1600 mg | Experimental | S-2367 1600 mg q.d. + reduced calorie diet Receives: Drug: S-2367 1600 mg; Other: Reduced Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 54 weeks
Secondary outcomes (3)
Change in body composition: calculated body mass index, waist circumference, hip circumference, and calculated waist-to-hip ratio
Change in body weight, waist measurement, and hip measurement
Measured: 54 weeks
Steady-state/trough pharmacokinetic analysis
Trough plasma concentration at various times after start of treatment
Measured: After 3, 12, 24, 36, and 54 weeks
Safety and tolerability of S-2367
number of adverse events or changes in laboratory values
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747929
- Sponsor's protocol ID
- 0701A2823
- Status last verified
- May 2018
- First submitted
- 5 Sep 2008
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0, 800, or 1600 mg/Day of S-2367 Administered Orally Once Daily With a Reduced Calorie Diet in Obese Males and Females
- ClinicalTrials.gov ID
- NCT00747929
- Acronym / sponsor ID
- 0701A2823
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure
- To evaluate the steady-state/trough pharmacokinetics of S-2367
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S-2367 Placebo | Placebo comparator | Drug: S-2367 Placebo, Other: Reduced Calorie DietPlacebo + reduced calorie diet |
| S-2367 800 mg | Experimental | Drug: S-2367 800 mg, Other: Reduced Calorie DietS-2367 800 mg q.d. + reduced calorie diet |
| S-2367 1600 mg | Experimental | Drug: S-2367 1600 mg, Other: Reduced Calorie DietS-2367 1600 mg q.d. + reduced calorie diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-2367 Placebofour 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, | Drug | S-2367 Placebo |
| S-2367 800 mgAlso: Velneperittwo 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 | Drug | S-2367 800 mg |
| S-2367 1600 mgAlso: Velneperitfour 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, | Drug | S-2367 1600 mg |
| Reduced Calorie DietA diet with restricted calorie content | Other | S-2367 1600 mg, S-2367 800 mg, S-2367 Placebo |
Primary outcome
The change in body weight over the 54-week active therapy phase of the study
Time frame: 54 weeks
body weight at 54 weeks compared to body weight at start of treatment
3 secondary outcomes
Change in body composition: calculated body mass index, waist circumference, hip circumference, and calculated waist-to-hip ratio
Time frame: 54 weeks
Steady-state/trough pharmacokinetic analysis
Time frame: After 3, 12, 24, 36, and 54 weeks
Safety and tolerability of S-2367
Time frame: 54 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-2367 800 mg, S-2367 1600 mg and Reduced Calorie Diet in people with Obesity, run by Shionogi at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in body weight over the 54-week active therapy phase of the study (time frame: 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.