PLEASE NOTE THE FOLLOWING:

      Compensation will be done in multiple payments.

       Age requirements for this study are different for males and females. See below.

 

      Females must have regular menstrual cycles and will need to report their last 3 cycles start and stop dates. You must bring this information to your appointment.

 *Update Dec 27, 2018 - Amendment occured - Females must have a bilateral tubal ligation, bilateral salpingectomy or must be using non-hormonal IUD.  No other methods are allowed.

      Females with a non-hormonal intrauterine device (IUD) must bring either a print out from their pharmacy OR a prescription OR doctor's records or note to confirm they are on this method and for how long.

      Females with tubal ligations or salpingectomies (fallopian tubes removed) need to bring documentation to screening.

 

      *Note: Males who dosed for study NO 0009-0206 are excluded from this study.  CALL TO SEE IF YOU WERE GIVEN PLACEBO, THESE PATIENTS CAN NOW DO THE STUDY.

    This study has a $500 Refer A Friend.

          _________________________________________________________________

 

Healthy Overweight & Obese NO 0009-0250

San Antonio - Texas

ICON Early Phase Services is looking for men and women who are overweight or have obesity but otherwise healthy for a clinical research study.  This study is being done to test an investigational product for weight management. The study drug will be administered by subcutaneous injections. 

The very first appointment will be the information session where you will be given information about the study.  Please note, you do not have to fast for the information visit.  You will have the opportunity to ask questions and receive further information on the study and you will also be given an informed consent form. No study procedures will be performed at this first appointment and no fasting is required for the information session appointment. After you receive information on the study and have the opportunity to ask your questions, you may either decline participation in the study or agree to participate and sign the study informed consent form. If you agree to participate in the study, the study staff will schedule with you a screening visit appointment and will provide you with the requirements for the screening visit, inform you about what procedures will be done at the screening visit, may schedule you for a DEXA scan that will take place at another facility, and will discuss with you about what medical records and documents you should bring to the screening visit.

Please review the information below and determine whether you are interested in the study and would like to schedule your information session appointment.

Vital signs, ECGs, physical examinations, DEXA scans, pregnancy test and pelvic ultrasound for females of childbearing potential, and drug and alcohol screens will be performed during the study. Blood and urine samples will also be obtained during this study. 

After the information session appointment and if you agree to participate in the study and sign the study informed consent, you will be invited and scheduled to complete a screening visit.

To determine if you fully qualify, it will be necessary to obtain blood samples after a 12- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you may need to provide medical records at screening.  For more information, see below.

 

Qualified participants may be compensated up to $8,400 for time and travel.  If you qualify to participate in the study, your participation will take approximately 3 months and you will need to attend:

  • 8 overnights (over 5 periods)
  • 13 outpatient visits
  • NOTE: Some females may require extra visits

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am a healthy adult who is overweight or has obesity and no significant medical conditions

 

  • I am Male and between 22 and 55 years old

 

  • I am Female and between 22 and 45 years old

 

  • My BMI is between 27.0 and 39.9 kg/m(inclusive)

 

  • I do not smoke or use any tobacco or nicotine products.  I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.

 

  • I have not participated in (nor am I currently participating in) any clinical research study of an approved or non-approved investigational medicinal product within 30 days before screening

 

  • I am a Female with regular menstrual cycles (defined as 24-35 day cycles between 1st day of menses for the two most recent menstrual periods)

 

  • If Female, I am not pregnant or breastfeeding and I do not intend to become pregnant

 

  • If Female, I am not post-menopausal

 

  • If Female, I am either surgically sterile by tubal ligation, or I agree to use a non-hormonal intrauterine device or diaphragm/cervical cap with spermicide in combination with condom for male partner(s)  *Update Dec 27, 2018 - Amendment occured - Females must have a bilateral tubal ligation, bilateral salpingectomy or must be using non-hormonal IUD.  No other methods are allowed.

 

  • If Female, I have not used hormonal contraceptives (oral contraceptives, implant or hormonal intrauterine device) within 3 months before screening

 

  • If Male, I have had a vasectomy, or, I agree to use a condom with spermicidal foam/gel/cream combined with an approved contraceptive method if my partner is capable of becoming pregnant (e.g., implants, injectables, oral contraceptives, intrauterine devices, diaphragm, or cervical cap with spermicide)

 

  • If Male, I agree not to donate sperm from screening to 90 days after last dose of study drug

 

  • I am able to communicate effectively in English with the study personnel

 

  • I do not anticipate a change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study

 

  • I do not have a risk of atherosclerotic cardiovascular disease (NOTE: for subjects age 40+)

 

  • I do not have a history or presence of any cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, arrhythmias and conduction disorders

 

  • I do not have a history or presence of bone disease or an increased risk of bone fracture

 

  • I do not have a history or presence of cancer within the last 5 years prior to screening. (NOTE: Except for cured basal and squamous cell skin cancer and in-situ carcinomas.)

 

  • I do not have a history or presence of sleep apnea

 

  • I do not have any special diet requirements and I am willing to eat the food provided while on-site and overnight stays

 

  • I have not had any prior obesity surgery and I do not have a gastrointestinal implant

 

  • I have not had a clinically significant weight change (e.g., ≥5% change), I have not dieted within 90 days prior to screening, and I am not participating in an organized weight reduction program

 

  • I do not have any history of psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression or anxiety)

 

  • I have not taken any prescription or nonprescription medications, herbal products, or non-routine vitamins within 2 weeks prior to screening. (NOTE: Mild painkillers are allowed until 24 hours before screening.)

 

  • I do not have a history of alcohol abuse, within 12 months of screening (e.g. more than 7 units/weekly for females and more than 14 units/weekly for males)

 

  • I do not have a history of drug abuse/chemical substance abuse within 12 months before screening

 

  • I have not donated blood, donated plasma in the last 60 days or had numerous blood draws within the past 30 days before screening

 

  • I do not have a history of any severe or life-threatening allergies or a history of anaphylactic reactions (e.g., food or medications or latex)

 

  • I have not had problems having blood drawn in either arm, venous access or finger pricks.

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures, including a DEXA scan for body fat and composition and an abdominal or pelvic ultrasound for females.  Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests.  Attending an information session and/or scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

After you attend the information session at the site and agree to participate in the study, the study staff will have to determine if you fully qualify. It will be necessary at the next visit to obtain blood and urine samples after a 12-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 12 hours before your screening appointment.  We will be testing for tobacco and drug abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID and your Social Security Card with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, or passport.  Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.   *Note: As of Nov. 01, 2018 our policy has changed and MILITARY IDs ARE NOW ALLOWED. 

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as tubal ligation. 

 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

 CLICK HERE To Make An Appointment for NO 0009-0250

      *Compensation will be in multiple payments.

 

      ______________________________________________

STUDY DATES - Note: All dates and times are tentative and may change.

  You cannot pick which cohort you are in.  The female only cohort will be filled before proceeding to the combined female and male cohort.

 

 Cohort 4C

        1st Admit: Feb 11, 2019 Mon - Discharge: Feb14, 2019 Thurs

           Outpatient Visits: Feb 20,  Feb 27

        2nd Admit: Mar 06, 2019 Wed - Discharge: Mar 07, 2019 Thurs

            Outpatient Visits: Mar 13, Mar 20, Mar 27

        3rd Admit: Apr 03, 2019 Wed - Discharge: Apr 04, 2019 Thurs

             Outpatient Visits: Apr 10, Apr 17, Apr 24

        4th Admit: May 01, 2019 Wed - Discharge: May 03, 2019 Fri 

             Outpatient Visits:  May 08, May 15, May 22, May 29

        5th Admit: Jun 03, 2019  Mon - Discharge: Jun 04, 2019 Tue  *Final day for most patients

       * Only Females with Irregular Menses will do these additional Visits.

           Phone Call: Jun 18, 2019

           Outpatient Visit: Jul 02

           Phone Call: Jul 16

           Outpatient Visit: Jul 30

           Final Visit: Aug 13

  

 

Notice:

In order to schedule your appointment online for the information visit, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.  

 

PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

 

Reference NO 0009-0250
Name
Details Healthy Overweight & Obese NO 0009-0250 - Evening appointments available for females. MORE FEMALES NEEDED! This study has a $500 Refer A Friend.
Gender Male or Female
Dates -
Payment amount up to $8,400
Age 22 - 55

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