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.
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-hourfast. 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 yourscreening 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.