Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects

What this study is testing ClinicalTrials.gov NCT05548647 ↗

Description as written by the study sponsor.

This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. 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) for 72 weeks.

Treatments tested

• Behavioral Treatment also known as Lifestyle modification, Behavioral weight loss, Lifestyle intervention Behavioral

  All participants, regardless of medication assignment, will receive the same 60-week behavioral weight loss program. Brief (15-minute), individual lifestyle counseling sessions will be delivered by a psychologist, behavioral health counselor, or registered dietitian (or other trained health care provider) at weeks 0 (i.e., baseline/randomization), 2, 4 and every fourth week from week 4 to week 60 (17 sessions) of Study 1. Subjects will be instructed to consume a self-selected diet of 1200-1500 kcal/day (for those who weigh \< 250 lb) or 1500-1800 kcal/day (for those who weigh ≥250 lb). They will be instructed to engage in low-to-moderate intensity physical activity (e.g., walking), gradually building to a goal of ≥150 minutes per week (spread across 5 days) by week 40. They will be instructed to use calorie counting and self-monitoring to meet their goals.

• Placebo also known as Placebo for medication Drug

  An inactive saline solution administered via subcutaneous injection

• Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] also known as Wegovy Drug

  Semaglutide 2.4 mg is a once weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist that has been FDA approved for weight loss