SPECIAL NOTICE FOR OUT-OF-STATE SUBJECTS

                            Due to the number of required visits over an exteneded period, out-of-state subjects will not be accepted into this study. We apologize for any inconvenience this may cause.

                   SPECIAL NOTICE FOR ALL SUBJECTS

                           Subjects screening for this study must bring proof that they reside in Texas. Examples include - Texas driver's license/ID or an electric or water bill from a Texas address.

 

                   There is a 2 part screening for this study.  You do not need to be fasting for the first screening visit.

 

                     *There is no waiting list for this or any of our other studies.*

                                      _____________________________________

             

Healthy NO 0009-0431

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 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, physical examinations, ECGs, hormone level evaluation and drug and alcohol screens will be performed. 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 an 8-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 $10,055 for time and travel.  If you qualify to participate in the study, your participation will vary in length from approximately 71 to 134 days (depending upon dose) plus a screening period of 2 to 28 days.  You will need to attend:

 

  •  Up to 2 screening visits
  •  3 partial days
  •  16 overnights for the first visit 
  •  1-night/2-day visit at the end of study
  •  5 outpatient 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 between 18 and 60 (inclusive) years old

 

  • My BMI is between 27.0 and 34.9 kg/m2  inclusive

 

  • I have not participated in another clinical trial within 30 days before screening

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female, I am not capable of becoming pregnant.  I have been postmenopausal for at least 1 year or I am surgically sterile (tubes tied, uterus removed, tubes removed) or I was born sterile.   

 

  • If Male and I am sexually active with a partner capable of becoming pregnant, I have been sterilized (by vasectomy) or my partner must be willing to use a highly effective form of contraception.  Acceptable methods of contraception are:

      

  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable)
  • Implantable progestogen-only hormonal contraception associated with inhibition of ovulation (intrauterine device (IUD), intrauterine hormone-releasing system (IUS)

 

  • If Male, I do not plan to donate sperm in the period from screening until at least 4 weeks after the last follow-up visit 

 

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

 

  • I do not have a history or suspected drug/chemical substance abuse within 1 year prior to the day of screening

 

  • I do not have known or suspected alcohol abuse within 1 year prior to the day of screening.  Abuse is defined as regular intake of more than an average of 24 g (2 units) of alcohol. 

 

  • I have not recently used prescription or non-prescription products, including herbal products and non-routine vitamins

 

  • I do not have unusual meal habits or special diet requirements and I am willing to eat the food provided in the trial

 

  • I have not recently donated blood or plasma or had a large blood draw

 

  • I do not have a history or presence of cardiovascular disease

 

  • I have not recently had a clinically significant body weight change or dieting attempts (e.g., participation in a weight reduction program)

 

  • I do not anticipate a change in lifestyle while on study (such as a change in eating, exercise or sleeping pattern)

 

  • I have not had any prior obesity surgery or currently present gastrointestinal implant

 

  • I do not have a history or presence of psychiatric disorders

 

  • I am able to attend visits fasting as required by the study

 

  • I am able to comply with the limits for caffeine and alcohol consumption as required by the study

 

  • I am willing to keep my current patterns of exercise from screening until completion of the last follow-up visit

 

  • I am willing to comply with the study restriction of no illegal drugs or substance abuse from screening to the last follow-up visit.

 

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. 

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 an 8-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 8 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 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, military ID or passport.  You will be required to show this same photo ID at all study visits.

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 hysterectomy, bilateral oophorectomy and 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 0009-0431

                            *2 part screening for this study (1st visit - sign consent, 2nd visit - procedures)

                              * Compensation in multiple payments.

                           ____________________________________

 

         STUDY DATES - Note: All dates and times are tentative and may change. You cannot pick which cohort you do.  The first cohort is filled before we move to the next.

 

                    Cohort 3A

                          1st Admit: Oct 30 Wed, 2019 Sat -  Discharge: Nov 15, 2019 Fri

                                Outpatient Visits: Nov 22 Fri,  Nov 29 Fri, Dec 06 Fri,  Dec 13 Fri,  Dec 27 Fri

                           2nd Admit: Jan 09, 2020 Thur  -  Discharge: Jan 10, 2020 Fri

 

             

                     Cohort 3B

                           1st Admit: Nov 11, 2019 Mon -  Discharge: Nov 26, 2019 Tue

                                 Outpatient Visits: Dec 04 Wed,  Dec 11 Wed,  Dec 18 Wed,  Dec 25 Wed, Jan 08, 2020 Wed

                            2nd Admit: Jan 21, 2020 Tue  -  Discharge: Jan 22, 2020 Wed

          

 

 

Notice:

In order to schedule a screening appointment online, 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 0009-0431
Name
Details Healthy NO 0009-0431 - 2 part screening (1st visit- sign consent, 2nd visit- procedures). Females must be postmenopausal or surgically sterile. NO out-of-state subjects allowed.
Gender Male or Female
Dates -
Payment amount up to $10,055
Age 18 - 60

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