Summary:
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 NOTE THE FOLLOWING:
Compensation in multiple payments.
Females must have regular menstrual cycles and will need to report their last 2 cycles start and stop dates. Please bring this information to your appointment.
Females with tubal ligations need to bring documentation to screening.
*Note: Males who dosed for study NO 0009-0206 are excluded from this study.
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.
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 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)
- 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.
Qualified Participants May Receive:
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:
- 6 overnights (over 4 periods)
- 13 outpatient visits
- NOTE: Some females may require extra visits