We are researching if switching to monthly doses of the investigational study medicine can help people keep their weight off over time.
Your participation and commitment may make a difference for you and others who are currently on a weekly injection schedule for managing their weight.
Who may participate
Each clinical trial has its own guidelines for who can participate called eligibility criteria. Some of the eligibility criteria to participate in this clinical trial include:
Overweight or obesity
Are currently taking semaglutide or tirzepatide. Participants cannot be on compounded semaglutide or tirzepatide
Type 2 diabetes
Do not have type 2 diabetes
Age
18+ years
Additional requirements apply
The study team will discuss other requirements with you and determine if you are eligible to participate in this clinical trial.
What to expect
If you decide to join this clinical trial, the study team will perform some screening tests to see if the study is a good fit for you.
This clinical trial will last about 11 months and includes up to 12 clinic visits. At each clinic visit, the study team will perform health tests to monitor your well-being and track if you are maintaining your current weight.
At the beginning of the clinical trial, you will be randomly assigned (like pulling a number out of a hat) to receive either the investigational study medicine or to continue your current approved weight management therapy of either semaglutide or tirzepatide. Throughout the study, you will also receive guidance on continuing healthy eating habits and physical activity to help you maintain your weight. All study treatment options will be given as injections under the skin.
Study related costs
No cost to participate, and health insurance is not required
About the study medicine
The investigational study medicine is a GLP-1 RA (glucagon-like peptide-1 receptor agonist). It mimics the effects of a hormone in your body called GLP-1. Along with a healthy diet and exercise, it may help people maintain their weight by:
- Increasing a feeling of fullness after eating
- Reducing appetite
- Regulating blood sugar levels
The investigational study medicine is designed to be long acting, which may allow people to maintain their weight over time with only 1 dose per month.
Every participant in the clinical trial will receive active treatment, whether it is the investigational study medicine or continuing their current, approved therapy of either semaglutide or tirzepatide.
Why your participation matters
For people living with overweight or obesity, finding solutions to manage their weight can be a challenge. Many factors—including age, sex, race, ethnicity, other health conditions, and lifestyle—can affect a person’s weight and how they respond to weight management treatment.
We recognize how personal and complex weight management can be. That’s why we’re researching new ways to help people maintain their weight.
Since people respond to treatment differently, it’s important for this clinical trial to include participants from a wide range of backgrounds. This will help us better understand how the investigational study medicine works for different people.
Your participation and commitment could make a difference for you and others who also struggle with managing their weight.
Frequently asked questions
If you qualify and decide to participate, you will receive:
- All study-related visits, assessments, and your assigned study treatment option at no cost
- Reimbursement for study-related expenses such as parking and other transportation costs
- Guidance on continuing healthy eating habits and physical activity
No matter which group you are in, you will receive active treatment. You will also be making a difference to our understanding of maintaining weight over time and how the investigational study medicine works.
Based on what is known of the GLP-1 RA medicine class, some people may have stomach-related side effects. These include feeling like you need to throw up (nausea), throwing up (vomiting), watery stools (diarrhea), trouble having a bowel movement (constipation), or discomfort in the upper belly or abdomen (indigestion). The study team can suggest simple ways to help manage these effects, such as eating smaller meals, drinking plenty of fluids, and only eating when you feel hungry.
There are other common side effects that the study team will explain before you join the clinical trial.
We recognize that maintaining your weight can be as challenging as losing weight. During the study, you will receive guidance on continuing healthy eating habits and physical activity to help you maintain your weight.
Participation is completely voluntary. You can leave the clinical trial at any time, for any reason, and without affecting your regular medical care or benefits.
