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ObesityPhase 2OLENCT00788528

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

A Phase 2 study testing S-2367 (velneperit) in people with Obesity, run by Shionogi at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
S-2367 (velneperit)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
73 sitesUnited States
Study dates
Aug 2008to Mar 2010
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

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
  • 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
Show all 21Show fewer
  • 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
  • Current or planned use of any prescription or nonprescription over-the-counter (OTC) medication/product or herbal/phytotherapeutic/plant-derived medications/products 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, etc. Note: Use of any other medications/products for weight control, appetite suppression, treatment of obesity is prohibited during the course of this OLE study
  • Current or planned use of chronic medications/products that are known to cause weight gain during the entire OLE study. The list includes but is not limited to amitriptyline (ELAVIL), paroxetine (PAXIL), setraline (ZOLOFT), and mirtazepine (REMERON). Additional clarification is provided in the concomitant medications section and Appendix B and updates or clarifications to these sections. Investigators are to discuss with the Sponsor's Medical Monitor any concomitant medications about which they are uncertain
  • Current or planned use of any prescription or non-prescription OTC medications/product, unless deemed acceptable by the Investigator. Some examples of allowed medications are stable use (during RCD or LCD Study) of: hormone replacement therapy (e.g., for postmenopausal women); antihypertensive agents (e.g., for hypertensive subjects); statins (e.g., for hyperlipidemia); thyroid replacement therapy (e.g., for hypothyroid subjects and provided thyroid replacement therapy has been stable during the RCD or LCD study 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 also be allowed. Continued, stable, moderate use (during the RCD or LCD study) 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
  • Planned donation of blood or blood products during the entire OLE study
  • Current poor peripheral venous access that would preclude blood collection
  • 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

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Boise, Idaho, 83704

  • Study site

    Boston, Massachusetts, 02135

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Burlington, North Carolina, 27215

  • Study site

    Burns, Tennessee, 37029

  • Study site

    Carmichael, California, 95608

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chicago, Illinois, 60654

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Concord, North Carolina, 28025

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Cranston, Rhode Island, 02920

  • Study site

    Edison, New Jersey, 08817

  • Study site

    Endwell, New York, 13760

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Green Bay, Wisconsin, 54303

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Gulfport, Mississippi, 39501

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77024

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Jackson, Texas, 77566

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jacksonville, Florida, 32259

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    Las Vegas, Nevada, 89146

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Manlius, New York, 13104

  • Study site

    Milford, Massachusetts, 01757

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mogadore, Ohio, 44260

  • 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

    Omaha, Nebraska, 68134

  • Study site

    Orlando, Florida, 32809

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Renton, Washington, 98057

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Sacramento, California, 95816

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92108

  • Study site

    San Francisco, California, 94102

  • Study site

    Shawnee Mission, Kansas, 66218

  • Study site

    South Dartmouth, Massachusetts, 02747

  • 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

  • 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

Other trials in United States

About this study

Official title: Open-Label Extension (OLE) Safety and Efficacy Study of Velneperit (S-2367) Following the Year-Long Controlled Clinical Trials of S-2367 in Obese Males and Females

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

Conditions
Obesity
Being tested
S-2367 (velneperit)
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 (velneperit)Drug

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

Study groups in NCT00788528
Study groupRoleWhat they receive
Arm AExperimental1600 mg S-2367 (velneperit)
Receives: Drug: S-2367 (velneperit)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 54 weeks

  2. 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

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

Secondary outcomes (2)

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

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

  2. 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

    Measured: Weeks 3, 24, and 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionFeb 2010
  4. Study completionMar 2010

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788528
Sponsor's protocol ID
0813A2825
Acronym
OLE
Status last verified
Apr 2018
First submitted
7 Nov 2008
Last updated
1 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-2367 (velneperit) in people with Obesity, run by Shionogi at 73 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 21 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 1 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 73 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. 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?

Efficacy assessment: The change in body weight over the 54-week active therapy phase of the study is the primary efficacy variable (time frame: 54 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00788528.

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 1 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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