The Pfizer New Haven Clinical Research Unit is conducting a clinical trial of an oral study drug for obesity and weight management. Part D of this study will look at the effects of the study drug combined with an additional injectable medication.
Obesity is a chronic weight condition that increases the potential risk of other illnesses such as stroke and diabetes. By 2030, it is projected that over a billion people worldwide will be considered obese.
While the scientific and medical community defines obesity as a complex, multifactoral chronic disease requiring prevention and treatment efforts, there are still many misconceptions and stigma associated with this condition which can further impact patients’ quality of life and access to healthcare. Most people with obesity do not receive any treatment, and diet and lifestyle are often not effective at long-term weight management for many patients.
Read more about how you can help change lives as a healthy volunteer.
Who may participate
Every modern medical discovery starts with a clinical trial, and every clinical trial starts with the amazing people who volunteer.
This study is seeking adult volunteers who are in overall good health, meaning no significant recent changes in medical status and without uncontrolled medical conditions. In addition to the criteria listed, participants must meet the following requirements:
- Willing and able to self-administer an injectable medication at home
- Willing and able to come to our facility in New Haven, CT*
- Current BMI of 30-40
*participants may be eligible to receive a bonus for travel, ask our staff for details
**females must be unable to bear children
There are other requirements for participation in this study. The study staff will explain these to you during the screening process.
Do you know someone who may meet these requirements? Refer a friend and you may be eligible to receive a bonus.
Condition
Obesity and weight management
Age
18-65 years
Sex
All sexes**
Referral bonus
Up to $250
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this study may be a fit for you, you’ll be invited to a screening visit at our facility in New Haven, CT. If you qualify for the study, there may be a period of up to 28 days before dosing.
If you choose to participate, there will be a period of outpatient dosing followed by an inpatient stay. During the outpatient period, you will come to the PCRU once a week for 4 weeks. At each visit, you will receive one dose of a medication injected subcutaneously (beneath the skin). You will also be given information and supplies to self-administer the same injectable medication daily at home, and you will be asked to keep a diary of these doses and other specific information to be reviewed at the next visit. You will also only receive a week of supplies at each appointment, so it is very important to complete each visit. The schedule will be reviewed with you ahead of time so please communicate any issues as soon as you can.
A week after the 4th outpatient visit, you will be asked to come stay at our facility for 25 consecutive nights. During your stay, you will continue receiving daily doses of the injectable medication for another 3 weeks. One week after admission, you will also begin receiving oral doses of the study drug or placebo once daily for 14 days. The study drug and placebo may be dosed with or without food. At some points during your stay, you will also complete oral glucose tolerance testing after dosing, which is a procedure to see how your body processes a larger amount of sugars. Dosing of all medications will end about 3 days prior to discharge from the PCRU.
Throughout the study, staff will closely monitor your health status and collect data, such as the levels of the study drug in your blood.
Required overnight stays
25 consecutive overnights
Long-term follow up
1 visit + 1 phone call
How long is this study?
About 77 days
Compensation
Up to $12,406 upon completion of the study
All of the study procedures will be clearly explained to you during screening and can be viewed by downloading the informed consent form.
The PCRU Loyalty Program has arrived!
Our new Loyalty Program offers unique tiered gifts for new and returning participants.
Interested in participating?
Complete and submit this form, and a Pfizer New Haven Clinical Research Unit (PCRU) representative will contact you. Please note: volunteers completing this form must be able to read and speak English at an 8th grade level.
You may also call 1-800-254-6398 and speak with a PCRU representative to learn more.
For Japanese language assistance only, please call 1-833-711-9984. We apologize, our representatives cannot take calls in languages other than English or Japanese at this time.
The personal data gathered here will be collected, processed, and maintained in a confidential manner. Your information will be stored in our research unit’s database. We may use this information to invite you to participate in current and future clinical studies at the PCRU. You will have full access to your records at the Pfizer New Haven Clinical Research Unit and the opportunity to correct them if necessary.