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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05548647
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Treatment — 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 — DRUG
    An inactive saline solution administered via subcutaneous injection
  • Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [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

Study Details

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.

Key Dates

First listed
Sep 21, 2022
Start date
Jul 26, 2022
Status verified
Jul 2026
Primary completion
May 12, 2025
Completion
May 12, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)
    Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60. At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).
  • Active Comparator: Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)
    Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60. At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the semaglutide-to-semaglutide group was not intended to be subject to statistical analysis. Therefore the week 72 results for this group represent those of the semaglutide-to-placebo group who took semaglutide for 60 weeks and then placebo for the last 12 weeks.

Primary Outcome Measure

Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast) [ Time Frame: S1: Change from baseline to weeks 20, 40, and 60 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Center for Weight and Eating DisordersPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Pennsylvania Center for Weight and Eating Disorders· Philadelphia, PA

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