NCT05579977-2

If you have struggled to make lasting progress towards a healthy weight, a Pfizer clinical trial for an investigational oral medication may be an option for you. Participating in our clinical trial also includes support services such as diet and exercise counseling.

The study drug being developed is a once-daily pill that works differently than other approved oral medications because it may slow down your digestion and help you feel fuller longer. Take the next step toward gaining better control of your weight and see if you qualify for this clinical trial.

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Who may participate

 

You may be able to participate if you:

• Have struggled to reach or maintain a healthy weight
• Do not have diabetes

Condition

Obesity

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues such as lifespan, quality of life, and health risks.

Age

18 to 75 years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

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.

Get started — See if you may qualify

A first step as you consider this study is to answer a 5-minute questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.

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What to expect

 

If you qualify and decide to participate, you will receive:


• All clinical trial-related care, the oral study drug, and diet and exercise counseling at no charge
• Close monitoring by a study physician of your weight and overall health
• Reimbursement for any reasonable expenses that you may have as a result of taking part in the study such as parking, meals, or other travel-related expenses
• The opportunity to help advance scientific knowledge and potentially improve the care of people who need support with weight loss

Your safety while participating is our highest priority. If you have questions or concerns at any point, a study team member is available. Your participation is voluntary, and you are free to withdraw at any time. Your privacy will be maintained
throughout the study.

Length of study treatment

Up to 44 weeks

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Up to 14 study visits Up to 8 telephone contacts

Each study’s design specifies the number of study visits and the total length of the trial.

Long-term follow-up

4 weeks total, including 1 site visit and 1 telephone contact

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow-up is to collect additional information on the study drug over time.

About Obesity

Obesity is a complex medical disease that occurs when the body accumulates a large amount of excess fat.1 Obesity can be caused by a variety of factors, including eating patterns, lack of sleep or physical activity, family history, and some medications.2 Losing weight and maintaining long-term weight loss is challenging, and medication can often be used to successfully support healthy lifestyle changes.

Frequently asked questions

Why is Pfizer conducting this weight loss clinical trial?

Pfizer is conducting this weight loss clinical trial to see if an oral, once-daily study drug may be an option to help people gain better control of their weight.

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What will happen if I take part in this study?

If you qualify and decide to participate, you will be in the study for up to 56 weeks (just over 1 year). There will be up to 15 visits to the study site and 9 telephone contacts.
There are 3 phases to this study. The Screening Period lasts up to 4 weeks and involves medical tests to see if you qualify for the study. The Study Treatment Period lasts up to 44 weeks. During this time, you will visit the clinic for health assessments and have telephone contacts with the study team. The Follow-Up Period lasts 4 weeks, during which time your overall health and weight will be evaluated.

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How do I decide if this study is right for me?

Before you agree to participate, the study team will go over all aspects of the study with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, the study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask any questions you have, then you can decide if participating is right for you.

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What is a placebo and is there a chance I will receive a placebo in this study?

A placebo looks like the study drug but does not contain any active drug. Yes, there is a chance that you will receive a placebo. You will be randomly assigned to take either the study drug or a placebo. There is a 5 in 6 (83%) chance you will receive the study drug, and a 1 in 6 (17%) chance you will receive a placebo.

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What happens to my personal information if I take part in the study?

The clinical research team will respect and protect your privacy and will not share your information except as required by law. Your personal information will be stored with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be protected.

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Can I leave the study early?

Yes, your participation is completely voluntary, so you may withdraw from the study, for any reason, and at any time. If you do decide to leave early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final visit and return any unused study drug.

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Is there a cost to participate?

No. You will get the study drug and all study-related medical tests at no charge. You will be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. These may include parking, meals, or other travel-related expenses. You do not need health insurance to take part.

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Do I need my doctor’s permission to participate?

No, you do not need your doctor’s permission to participate. However, either you or the study doctor, with your permission, may contact your personal physician to discuss your participation in the clinical research study before you begin and keep your physician up to date about your progress during the study.

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References:

  1. Obesity. Mayo Clinic. Accessed October 13, 2022. https://www.mayoclinic.org/diseases-conditions/obesity/symptomscauses/syc-20375742#:~:text=Obesity%20is%20a%20complex%20disease,blood%20pressure%20and%20certain%20cancers
  2. What are overweight and obesity? National Heart, Lung, and Blood Institute. Accessed October 24, 2022. https://www.nhlbi.nih.gov/health/overweightand-obesity