ObesityPhase 2NCT00748605
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
A Phase 2 study testing S-2367 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks and LCD (low calorie diet) in people with Obesity, run by Shionogi at 40 sites in United States.
Trial summary
1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically stable and… 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 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks and LCD (low calorie diet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 842 participants
- Where
- 40 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 (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
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 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Study site
Atlanta, Georgia, 30338
Study site
Augusta, Georgia, 30904
Study site
Bensalem, Pennsylvania, 19020
Study site
Birmingham, Alabama, 35209
Study site
Boise, Idaho, 83704
Study site
Boston, Massachusetts, 02135
Study site
Brooklyn Center, Minnesota, 55430
Study site
Burlington, North Carolina, 27215
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45219
Study site
Columbus, Ohio, 43212
Study site
Edison, New Jersey, 08817
Study site
Endwell, New York, 13760
Study site
Fort Worth, Texas, 76135
Study site
Fountain Valley, California, 92708
Study site
Gurnee, Illinois, 60031
Study site
Huntsville, Alabama, 35801
Study site
Jacksonville, Florida, 32259
Study site
Kansas City, Missouri, 64114
Study site
Las Vegas, Nevada, 89146
Study site
Lexington, Kentucky, 40509
Study site
Lincoln, Nebraska, 68510
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
New Braunfels, Texas, 78130
Study site
Ocala, Florida, 34471
Study site
Orlando, Florida, 32809
Study site
Phoenix, Arizona, 85014
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
San Francisco, California, 94102
Study site
South Dartmouth, Massachusetts, 02747
Study site
South Miami, Florida, 33143
Study site
St Louis, Missouri, 63141
Study site
Waterbury, Connecticut, 06708
Study site
Wauwatosa, Wisconsin, 53226
Study site
West Jordan, Utah, 84088
Study site
Wichita, Kansas, 67207
Study site
Winston-Salem, North Carolina, 27103
Study site
Yukon, Oklahoma, 73099
About this study
Official title: A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0 or 1600 mg/Day of S-2367 Administered Orally Once Daily With an Initial 6-Week Low Calorie Diet in Obese Males and Females
- To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically stable and otherwise healthy obese male and female subjects
- 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
- 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
- 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
- Conditions
- Obesity
- Being tested
- S-2367 Placebo, S-2367 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks, LCD (low calorie diet), RCD (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 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 WeeksDrug
Also called Velneperit
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 weeksDrug
Also called Velneperit
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)Other
A low calorie diet was utilized during the first 6 weeks of the study
RCD (reduced calorie diet)Other
A reduced calorie diet was used during the last 54 weeks for the study
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | S-2367 placebo + LCD (Low Calorie Diet) +RCD (Reduced Calorie Diet) Receives: Drug: S-2367 Placebo; Other: LCD (low calorie diet); Other: RCD (reduced calorie diet) |
| S-2367 1600 mg q.d. 54 weeks | Experimental | S-2367 placebo + LCD for 6 weeks and 1600 mg S-2367 + RCD for 54 weeks Receives: Drug: S-2367 Placebo; Drug: S-2367 1600 mg q.d. 54 Weeks; Other: LCD (low calorie diet); Other: RCD (reduced calorie diet) |
| S-2367 1600 mg q.d. 60 weeks | Experimental | S-23671600 mg q.d. + LCD for 6 weeks and S-2367 1600 mg q.d + RCD for 54 weeks Receives: Drug: S-2367 1600 mg q.d. 60 weeks; Other: LCD (low calorie diet); Other: RCD (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 60-week active therapy phase of the study
Measured: 60 weeks
Secondary outcomes (3)
Change in body composition: calculated body mass index, waist circumference, hip circumference, and calculated waist-to-hip ratio
Measured: Throughout the study
Steady-state/trough pharmacokinetic analysis
Measured: After 9, 18, 30, 42, and 60 weeks of study drug treatment
Safety and tolerability of S-2367: treatment emergent adverse events, clinical laboratory data, vital signs, and 12-lead electrocardiogram parameters at each visit
Measured: Throughout the study
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
- 842 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
- NCT00748605
- Sponsor's protocol ID
- 0702A2824 revised
- 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 or 1600 mg/Day of S-2367 Administered Orally Once Daily With an Initial 6-Week Low Calorie Diet in Obese Males and Females
- ClinicalTrials.gov ID
- NCT00748605
- Acronym / sponsor ID
- 0702A2824 revised
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 842 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 weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically stable and otherwise healthy obese male and female subjects
- 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
- 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
- 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
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: S-2367 Placebo, Other: LCD (low calorie diet), Other: RCD (reduced calorie diet)S-2367 placebo + LCD (Low Calorie Diet) +RCD (Reduced Calorie Diet) |
| S-2367 1600 mg q.d. 54 weeks | Experimental | Drug: S-2367 Placebo, Drug: S-2367 1600 mg q.d. 54 Weeks, Other: LCD (low calorie diet), Other: RCD (reduced calorie diet)S-2367 placebo + LCD for 6 weeks and 1600 mg S-2367 + RCD for 54 weeks |
| S-2367 1600 mg q.d. 60 weeks | Experimental | Drug: S-2367 1600 mg q.d. 60 weeks, Other: LCD (low calorie diet), Other: RCD (reduced calorie diet)S-23671600 mg q.d. + LCD for 6 weeks and S-2367 1600 mg q.d + RCD for 54 weeks |
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 (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
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 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 | Drug | Placebo, S-2367 1600 mg q.d. 54 weeks |
| S-2367 1600 mg q.d. 54 WeeksAlso: VelneperitFour 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 | Drug | S-2367 1600 mg q.d. 54 weeks |
| S-2367 1600 mg q.d. 60 weeksAlso: VelneperitFour 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 | Drug | S-2367 1600 mg q.d. 60 weeks |
| LCD (low calorie diet)A low calorie diet was utilized during the first 6 weeks of the study | Other | Placebo, S-2367 1600 mg q.d. 54 weeks, S-2367 1600 mg q.d. 60 weeks |
| RCD (reduced calorie diet)A reduced calorie diet was used during the last 54 weeks for the study | Other | Placebo, S-2367 1600 mg q.d. 54 weeks, S-2367 1600 mg q.d. 60 weeks |
Primary outcome
The change in body weight over the 60-week active therapy phase of the study
Time frame: 60 weeks
3 secondary outcomes
Change in body composition: calculated body mass index, waist circumference, hip circumference, and calculated waist-to-hip ratio
Time frame: Throughout the study
Steady-state/trough pharmacokinetic analysis
Time frame: After 9, 18, 30, 42, and 60 weeks of study drug treatment
Safety and tolerability of S-2367: treatment emergent adverse events, clinical laboratory data, vital signs, and 12-lead electrocardiogram parameters at each visit
Time frame: Throughout the study
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
40 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 1600 mg q.d. 54 Weeks, S-2367 1600 mg q.d. 60 weeks and LCD (low calorie diet) in people with Obesity, run by Shionogi at 40 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 40 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 60-week active therapy phase of the study (time frame: 60 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.