$8400 for new study obese healthy volunteers

[David Grey]

ICON Early Phase Services is looking for men and women who are overweight or have obesity but otherwise healthy for a clinical research study.


8307 Gault Lane
San Antonio, TX 78209

[phone]

View Study Website
Sponsored By: ICON Early Phase Services
Stipend: $8400 - $8400
Length of Study: 16 weeks
Research Facility: Out-Patient
Gender: Both
Age: 22 - 55
Health Condition: *Healthy Volunteers Studies

More Information: 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 appmately 3 months and you will need to attend:

6 overnights (over 4 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/m2 (inclusive)

I do not smoke or use any tobacco or nie 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). *See note at top of page regarding abstinence.

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 od 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 diss

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 diss (e.g., schizophrenia, bipolar dis, eating diss, depression or anxiety)