If you decide to join the SOLIS-1 study, you will be supported by a team of weight loss specialists and given a variety of tools to guide you every step of the way.
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
Have a body mass index (BMI) of:
- 30 to 50 OR
- 27 to <30 with a weight-related condition
Weight-related conditions (required for people with a BMI 27 to <30)
Have been diagnosed with a weight-related health condition such as high blood pressure, high cholesterol, sleep apnea, or heart disease
Type 2 diabetes
Have not been diagnosed with 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.
If you meet all the requirements, your participation will last about 18 months with clinic visits approximately every 1 to 4 weeks. During the study, you will have tests to monitor your health and weight.
During the Treatment Period, you will be randomly assigned (like pulling a number out of a hat) to receive 1 or both of the study medicines, or a placebo (no active medicine).
Both study medicines and the placebo will be given as an injection under the skin. You will be instructed on how to give yourself injections at home.
After you finish the Treatment Period, you will have 1 additional follow-up visit for the study team to check your health and weight.
Treatment Period
60 weeks
Study Visit Schedule
About 24 clinic visits
Study-Related Costs
No cost to participate, and health insurance is not required
About the study medicines
We’re researching 2 different study medicines to support weight management. We want to learn how each study medicine works when given alone as well as how they work when given together.
The first study medicine is a GLP-1 RA (glucagon-like peptide-1 receptor agonist). The second is a DACRA (dual amylin and calcitonin receptor agonist). They mimic the effects of hormones in your body called GLP-1 and amylin that help control your appetite and blood sugar. Along with a healthy diet and exercise, these medicines may help people lose weight by:
- Increasing a feeling of fullness after eating
- Slowing down digestion
- Reducing appetite
- Regulating blood sugar levels
Why this clinical trial is important
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 loss treatment.
We recognize how personal and complex weight management can be. That’s why we’re researching new ways to help people reach their weight loss goals.
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 study medicines work 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, counseling, and the study medicine(s) at no cost
- Reimbursement for study-related expenses such as parking and other transportation costs
- Ongoing counseling and resources on diet and physical activity from a team of weight loss specialists, including a personalized plan
- Resources and education to help you continue a healthy lifestyle even after the clinical trial is completed
The placebo looks like the study medicines but does not have any active ingredients in it. It is used so that researchers can see if there are differences in how people respond to the study medicines.
Whether you are in the placebo group or one of the study medicine groups, you will be making a difference to our understanding of how the study medicines work.
Because the study medicines affect digestion, some people may experience side effects like nausea, vomiting, diarrhea, and/or constipation. The study team can advise on ways to manage or minimize these types of side effects, such as eating smaller meals, drinking plenty of fluids, and eating only when hungry.
There are other common side effects that the study team will explain before you join the study.
The study team will work with you to develop a customized diet plan, including a reduced daily calorie intake goal, to help you lose weight in a healthy way.
They will also provide you with regular nutritional counseling to help you meet your weight loss goals.
You will be asked to complete at least 150 minutes of moderate exercise per week. A wide variety of resources will be available to help you plan your physical activities and keep you motivated.
Participation is completely voluntary. You can leave the clinical trial at any time, for any reason, without affecting your regular medical care or benefits.
