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

What Was Tested

The trial (phase 4) is built around Semaglutide.

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.

It had two arms (groups): Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72) (active comparator) and Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72) (active comparator).

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).

The registry classes the interventions as behavioral and drug.

More on the Plan

This trial consists of a single 72-week treatment period during which two studies will be conducted.

Study 1 (i.e., long-term treatment trial; weeks 0-60) is a 60-week, single center, double-blinded, randomized controlled, parallel group design trial, and Study 2 (i.e., re-randomized medication withdrawal trial; weeks 60-72) is a separate, 12-week, double-blind, re-randomized medication withdrawal trial.

They will complete assessments of energy intake, appetite, food reward, mood, symptoms of disordered eating, and anthropomorphic measurements at baseline (week 0) and weeks 20, 40, and 60.

Following the completion of Study 1 at week 60, all subjects who complete a week 60 assessment and remain on drug will be enrolled in Study 2.

Who Took Part

120 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women who report a desire to lose weight. Aged 18-70 years. Body mass index \[BMI\] ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with 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.

The full record lists 10 inclusion and 27 exclusion criteria; among the exclusions: A diagnosis of type I or II diabetes; uncontrolled hypertension (blood pressure ≥ 160/100 mm hg); uncontrolled thyroid disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-07-26 with completion listed for 2025-05-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main 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). Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast) (time frame: S2: Endpoint comparison at week 72).

It also tracked 14 secondary outcomes, for example Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ), Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ), Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ), Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version), Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task and Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 120 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.