STABLE Weight Loss Study (Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects)
Brief description of study
The STABLE Weight Loss study is a 72-week research study that is designed to help participants lose weight. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution). The purpose of the research is to test the long-term effect of the weight loss medication semaglutide on eating behavior, hunger, and food liking, as compared to placebo.
Detailed description of study
All participants will receive the same comprehensive lifestyle modification program of diet, physical activity, and behavior therapy counseling, which is currently recommended as the first-line treatment for weight loss.
Participants also will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution). This medication is taken once per week as an under the skin injection.
Study participants will be randomly assigned (flip of a coin) to take either semaglutide or placebo for 72 weeks in addition to their participation in the lifestyle modification program.
During the 72-week lifestyle counseling program, participants' weight, blood pressure, and pulse will be measured at every in-person lifestyle counseling visit. Participants also will have brief (5-10 minutes) medical visits with a study physician or nurse at weeks 20, 40, 60, and 72 (4 visits), as well as a follow-up medical visit at week 76.
All participants will be asked to attend five, 5-hour assessments of eating and appetite (hunger/fullness) at baseline (week 0), and at weeks 20, 40, 60, and 72. Participants will also answer questions about their eating, provide measurements such as weight and blood pressure, and have a blood draw at each assessment.
In order to participate, individuals must be available to attend in-person visits in Philadelphia between the hours of 9am - 5pm approximately every 8 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Obesity
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Age: Between 18 Years - 70 Years
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Gender: All
Body mass index [BMI] ≥ 30 kg/m2, or BMI 27-30 kg/m2 plus an obesity-related
comorbidity (e.g., treated or untreated hypertension, dyslipidemia, obstructive
sleep apnea, or cardiovascular disease)
Eligible female patients will be:
● non-pregnant, evidenced by a negative urine pregnancy test
● non-lactating
● surgically sterile or postmenopausal, or they will agree to continue to use
an accepted method of birth control during the study
Subjects must plan to remain in the Philadelphia area for the next 1.5 years.
Ability to provide informed consent before any trial-related activities.
Updated on
05 Mar 2024.
Study ID: 850370
