ARE YOU STRIVING TO ACHIEVE BETTER HEALTH?
About the SURMOUNT-MMO Study
The SURMOUNT-MMO Study is evaluating the effectiveness of an investigational medication (trial treatment) on reducing health risks that are commonly found in people who are living with obesity or are overweight. This clinical trial is focusing particularly on cardiovascular (heart) disease and other heart health risks.
Participants will be selected at random to receive either the trial treatment or a placebo, which looks like the trial treatment but does not contain active ingredients. To ensure the most accurate results, neither the participant nor the trial doctor will know which trial treatment they’ve been assigned.
The assigned trial treatment will be administered as a weekly injection, which will be done at home by the participant or a caregiver. Participants and caregivers will receive training on how to administer the injections during an appointment at the beginning of the trial.
The length of participation in the SURMOUNT-MMO Study will vary from person to person but may last up to five years or more, depending on how well the trial treatment is working. The trial schedule includes the following:
• Screening Period: four weeks (one visit)
• Dose Escalation Period: 24 weeks
• Maintenance Treatment Period: up to five years or longer (28+ regular visits; this duration depends on when the specific number of endpoint events for the final analysis occurs)
• Extended Maintenance (EMV) Period: every 12 weeks until the trial ends and the final visit occurs
During the treatment period, there may be an option to complete some visits remotely, at the direction and approval of the trial doctor.
Who May Qualify
Before interested individuals can join this clinical trial, they must be evaluated during the screening period. In order to participate, eligible participants must:
• Be at least 40 years of age
• Have a BMI of 27 kg/m2 or higher
• Have either established cardiovascular disease or cardiovascular risk factors
• NOT have type 1 or type 2 diabetes
To learn more, talk to your doctor or contact the trial site listed here.
Indago Research and Health Center Inc – 786-772-0510
What You Should Know about Clinical Trials
Clinical trials aim to answer specific questions about how investigational medications work in the volunteers who take them. You should feel fully informed about what to expect from participation in a clinical trial.
Researchers use clinical trials to:
• Answer specific health questions
• Learn about the effects and safety of investigational medications
• Help find new ways of using approved medications
Regulations and policies have been developed to help protect the rights, safety, and well-being of people who take part in clinical trials and to help ensure that these trials are conducted according to strict scientific and ethical principles. Before a clinical trial can begin, an institutional review board (IRB) or ethics committee (EC) must review the trial.
Participation in any clinical trial is completely voluntary, and you may withdraw from the trial at any time for any reason. Before volunteering for a clinical trial, it is important to weigh the potential risks and benefits of participation, which the trial site staff will inform you of, as well as possible side effects. To make an informed decision, gather as much information as possible and talk to your healthcare providers about any questions you may have.
Thank you for considering the SURMOUNT-MMO Study!