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ObesityPhase 2NCT01126970

Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects

A Phase 2 study testing Velneperit 400 mg, Orlistat 120 mg and Reduced Calorie Diet in people with Obesity, run by Shionogi at 25 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

To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat administered individually or combined three times per day for 24 weeks while on a reduced calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit (S-2367), velneperit (S-2367) tert-butyl OH, and… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Velneperit 400 mg, Orlistat 120 mg and Reduced Calorie Diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
486 participants
Where
25 sitesUnited States
Study dates
Apr 2010to Feb 2011
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females between 18 and 65 years of age at the time of informed consent
  • Body mass index (BMI) of 30.0 to 45.0 kg/m2 inclusive. BMI for study inclusion must be obtained from the Interactive Voice Response System/Web Response System (IVRS/WRS). (Visit 1 body weight and height obtained prior to the single-blind period will be used by the IVRS/WRS in the calculation.)
  • Weight that has not fluctuated by more than 3% for the 90 days prior to Visit 1
  • Non-smoker and no use of tobacco or nicotine products for at least 1 year prior to Visit 1
  • Normotensive or acceptable level of hypertension, defined as systolic <160 and diastolic <95 mmHg
  • No clinically significant laboratory abnormalities
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  • Negative urine drug screen for drugs of abuse
  • No clinically significant findings on medical history, physical examination, and electrocardiogram (ECG) and no known history of clinically significant ECG abnormalities
  • Negative serum pregnancy test in women of child-bearing potential (Females must be at least one year post-partum.)
  • Males either should remain abstinent, be sterile or agree to use an approved method of contraception (which for males includes use of a condom with spermicide) Visit 1 through 12 weeks following the last dose, in addition to having a female partner use an effective form of contraception as noted below
  • All female subjects must be non-pregnant (confirmed by a negative serum pregnancy test), have no plans of becoming pregnant during the study, and must be at least one year post-partum, non-lactating, postmenopausal, (defined as cessation of regular menstrual periods for at least one year and confirmed by a follicle-stimulating hormone test), or surgically sterile by hysterectomy and/or bilateral oophorectomy or tubal ligation. Females of child-bearing potential must agree to use acceptable forms of birth control including oral, implantable or transdermal 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 comply with all required study procedures and schedule
  • Able to speak and read English
  • Signed and dated informed consent form prior to any study-related procedures

Who cannot join

  • Obesity of known endocrine or genetic origin (eg, hypothyroidism, Cushing's syndrome or diagnosed polycystic ovarian syndrome) meeting one of the following conditions:
  • Menstrual irregularity due to oligo- or anovulation
  • Evidence of hyperandrogenism, whether clinical (hirsutism, acne, or male pattern balding) or biochemical (high serum androgen concentrations)
  • Exclusion of other causes of hyperandrogenism and menstrual irregularity, such as congenital adrenal hyperplasia, androgen-secreting tumors, and hyperprolactinemia]
  • History of malignancy within the previous 5 years with the exception of non-melanoma skin cancer or surgically cured cervical cancer
  • Human immunodeficiency virus (HIV) identified by history or previous HIV test
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  • Any serious medical condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study including any clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs
  • Known history or evidence of a psychiatric disorder that in the opinion of the investigator would preclude the subject from participating in the trial. Stable or controlled anxiety or depression are permitted. Treatment with an antidepressant or anxiolytic drug is permitted if in accordance with Appendix 4. Subjects with a score of 11 or higher on the depression portion of the Hospital Anxiety and Depression Scale are excluded.
  • Subjects with pancreatitis or chronic pancreatic inflammation
  • History of Type 1 or Type 2 diabetes mellitus as defined by HbA1c > 6.5% or blood glucose values of > 126 mg/dl or treated Type 2 diabetes mellitus
  • Any weight gain during the single-blind lead-in period (Visit 1 and Visit 3)
  • History of surgical or device (eg, gastric bypass) intervention for obesity 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 90 days prior to screening
  • History of alcoholism or drug addiction/substance abuse within 1 year of Visit 1. Note: No alcohol consumption is permitted within 48 hours prior to blood collections for analysis of lipid profiles.
  • Abnormal thyroid stimulating hormone level at screening
  • Subjects with hypothyroidism
  • Subjects with genetic hematologic disease or trait with or without manifestation of disease.
  • Use of chronic medications/products within 90 days prior to Visit 1 or during the study that are known to cause weight gain. Investigators will discuss with the Sponsor's Medical Monitor any concomitant medications about which they are uncertain.
  • Use of systemic corticosteroids or Depo Provera®
  • History of fenfluramine or dexfenfluramine (Fen-Phen) administration (except with a prior documented echocardiogram showing no valvular abnormalities.)
  • History of participation in any weight loss program within 90 days prior to Visit 1
  • Participation in any weight loss medication/product study in which receipt of weight loss medication/product occurred within 90 days prior to Visit 1
  • Use of any prescription or nonprescription over the counter medication/product or herbal/phytotherapeutic/plant-derived medications/products for weight loss, appetite suppression, weight control or treat obesity (includes investigational products) within 90 days prior to Visit 1 or during the study
  • Subjects with cholestasis or chronic malabsorption
  • Donation of blood or blood products 90 days prior to Visit 1 or during the study
  • Exposure to an investigative medication within the past 30 days or 5 half-lives, whichever is longer or concurrent participation in any clinical trial
  • Previous velneperit (S-2367) or other neuropeptide Y (NPY) Y5 agonist or antagonist use
  • 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
  • Positive Hepatitis B or C serology

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Augusta, Georgia

  • Study site

    Boston, Massachusetts

  • Study site

    Cary, North Carolina

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Greenville, South Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Louisville, Kentucky

  • Study site

    Manlius, New York

  • Study site

    Milford, Massachusetts

  • Study site

    Nashville, Tennessee

  • Study site

    New Braunfels, Texas

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    Ocala, Florida

  • Study site

    Ponte Vedra, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Renton, Washington

  • Study site

    Rochester, New York

  • Study site

    Santa Rosa, California

  • Study site

    St Louis, Missouri

  • Study site

    Waterbury, Connecticut

  • Study site

    Wauwatosa, Wisconsin

Other trials in United States

About this study

Official title: A Double-Blind, Multi-Center, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of 400 mg of Velneperit (S-2367) and 120 mg of Orlistat Administered Individually or Combined Orally Three Times Per Day With a Reduced Calorie Diet (RCD) in Obese Subjects

To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat administered individually or combined three times per day for 24 weeks while on a reduced calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of orlistat, either combined or separate.

Conditions
Obesity
Being tested
Velneperit 400 mg, Orlistat 120 mg, Orlistat Placebo, Velneperit Placebo, Reduced Calorie Diet
Keywords
reduced calorie diet, orlistat, velneperit
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Velneperit 400 mgDrug

    Also called S-2367

    Velneperit 400 mg q.d.

  • Orlistat 120 mgDrug

    Also called Xenical

    Orlistat 120 mg t.i.d

  • Orlistat PlaceboDrug

    Orlistat Placebo t.i.d.

  • Velneperit PlaceboDrug

    Velneperit Placebo q.d

  • Reduced Calorie DietOther

    Reduced calorie diet

Study groups in NCT01126970
Study groupRoleWhat they receive
Placebos.Placebo comparatorVelneperit Placebo q.d.+ Orlistat Placebo t.i.d.
Receives: Drug: Orlistat Placebo; Drug: Velneperit Placebo; Other: Reduced Calorie Diet
Velneperit 400 mgExperimentalVelneperit 400 mg q.d.
Receives: Drug: Velneperit 400 mg; Drug: Orlistat Placebo; Other: Reduced Calorie Diet
Orlistat 120 mgActive comparatorOrlistat 120 mg t.i.d.
Receives: Drug: Orlistat 120 mg; Drug: Velneperit Placebo; Other: Reduced Calorie Diet
Velneperit 400 mg + Orlistat 120 mgExperimentalVelneperit 400 mg q.d.and Orlistat 120 mg t.i.d
Receives: Drug: Velneperit 400 mg; Drug: Orlistat 120 mg; Other: Reduced Calorie Diet

What is being measured

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

  1. The primary efficacy endpoint was the change from baseline in body weight (kg) over the 168-day (24-week) double-blind treatment period, where baseline body weight was defined as the last measurement prior to randomization

    Change in body weight from baseline to 24 weeks

    Measured: 168 days (24 weeks)

Secondary outcomes (4)

  1. Efficacy analysis: The proportion of subjects with (a) a 5% decrease in body weight at Visit 7 and Visit 10 and (b) percent change in body weight from baseline to each study visit was summarized by treatment group

    Percentage of subjects who achieve a 5% decrease in body weight

    Measured: change from baseline to each study visit

  2. Efficacy analysis: The change in waist &amp; hip circumference (cm) from baseline to each study visit was summarized by treatment group

    Change in physical measurement from baseline

    Measured: Change from baseline to each study visit

  3. Efficacy analysis: The proportion of subjects with a decrease equal to or greater than 1 BMI unit at Visit 7 and Visit 10 was summarized by treatment group

    The proportion of subjects with decreases in BMI of 1 unit

    Measured: Baseline to Visits 7 and 10

  4. Safety analysis: (a) Treatment-emergent adverse events and (b) monitoring clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, and physical examinations

    Change from baseline to each visit and to Week 24

    Measured: Baseline to each visit and to Week 24

Timeline

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

  1. First posted20 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2011
  4. Study completionFeb 2011

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126970
Sponsor's protocol ID
1002A2828
Status last verified
May 2018
First submitted
17 May 2010
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Velneperit 400 mg, Orlistat 120 mg and Reduced Calorie Diet in people with Obesity, run by Shionogi at 25 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 14 inclusion and 28 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 9 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 25 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 primary efficacy endpoint was the change from baseline in body weight (kg) over the 168-day (24-week) double-blind treatment period, where baseline body weight was defined as the last measurement prior to randomization (time frame: 168 days (24 weeks)). 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 NCT01126970.

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 9 May 2018.

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Clinical Trial NCT01126970 | AzTrials