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

• Status: Recruiting
• Trial end date: 2025-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

1. Men and women who report a desire to lose weight

2. Aged 18-70 years

3. 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)

4. 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

5. 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.

Exclusion Criteria:

1. A diagnosis of type I or II diabetes

2. Hemoglobin A1c (HbA1c) > 6.5%

3. Uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg)

4. Clinically significant hepatic (i.e., liver fibrosis, cirrhosis or confirmed NASH) or renal disease

5. Uncontrolled thyroid disease

6. Experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 6 months, congestive heart failure, or heart block greater than first degree

7. A history of acute pancreatitis in the last 6 months

8. Any history of chronic pancreatitis

9. A history of malignancy (other than non-melanoma skin cancer) within the last 5 years

10. A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2

11. A self-reported change in body weight >5kg (11 lbs) within 90 days before screening

12. Used within the last 6 months medications known to produce weight loss/gain (e.g., medications approved for weight loss, oral steroids, antipsychotic medications) or any GLP-1 receptor agonist.

13. Known or suspected allergy or hypersensitivity to trial medication(s), excipients, or related products

14. The receipt of any investigational drug within 6 months prior to this trial

15. Applicants with current severe major depressive disorder (BDI-II score ≥ 29 or Patient Health Questionnaire-9 [PHQ-9] score > 15) or severe anxiety disorder

16. Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year (such individuals will be referred for psychiatric treatment if they have not previously received it).

17. Any severity of psychotic or bipolar disorder

18. Bulimia nervosa diagnosis within the past 5 years

19. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)

20. History of (or plans to receive in the next 1.5 years) bariatric surgery or a weight loss device. (However, the following will be allowed: liposuction or abdominoplasty > 1 year before screening, laparoscopic banding if removed > 1 year before screening, intragastric balloon or aspire assist if removed > 1 year before screening.)

21. Inability to walk 5 blocks or more (comfortably) or engage in another form of aerobic activity.

22. Women who are nursing, pregnant, or planning to become pregnant in the next 1.5 years or are not using adequate contraceptive measures

23. Previous participation in this trial (e.g., randomized but failed to participate)

24. Changes to any chronic medication (type or dosage) within the past 3 months.

25. Food allergy or dietary preference that would prevent the individual from consuming the standard breakfast or ad libitum lunch.