A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT05236517
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Semaglutide D Dose 1 — DRUGTablet given orally
- Semaglutide D Dose 2 — DRUGTablet given orally
- Semaglutide D Dose 3 — DRUGTablet given orally
- Semaglutide C Dose 4 — DRUGTablet given orally
- Semaglutide C Dose 5 (50 mg) — DRUGTablet given orally
- Placebo (Semaglutide C) — DRUGTablet given orally
- Placebo ( Semaglutide D) — DRUGTablet given orally
Study Details
This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal. In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks. The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.
Key Dates
- Start date
- Feb 8, 2022
- Status verified
- Sep 2024
- Primary completion
- Sep 29, 2022
- Completion
- Nov 7, 2022
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Semaglutide
- Placebo Comparator: Placebo
Primary Outcome Measure
Relative change in energy intake during ad libitum lunch [ Time Frame: Baseline to Day 140 ]
Related Studies
- Diabetes and Heart Disease Risk in BlacksRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Physical and Behavioral Traits of Overweight and Obese AdultsRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss TreatmentPHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phoenix, Arizona
- Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular SystemRecruiting · National Heart, Lung, and Blood Institute (NHLBI) · Washington D.C., District of Columbia