Clinical trial NCT05236517: A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
Official title: The Effect of Oral Semaglutide 50 mg Once-daily on Energy Intake, Gastric Emptying, Appetite, Control of Eating and Pharmacokinetics in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions

Primary outcomes:
measure: Relative change in energy intake during ad libitum lunch
timeFrame: Baseline to Day 140
Secondary outcomes:
measure: Change in energy intake during ad libitum lunch
timeFrame: Baseline to Day 140
measure: Change in amount of food consumed during ad libitum lunch
timeFrame: Baseline to Day 140
measure: Change in body weight
timeFrame: Baseline to Day 141
measure: AUC0-5h,para
timeFrame: 0-5h after standardised meal, Day 141
measure: AUC0-1h,para
timeFrame: 0-1h after standardised meal, Day 141
measure: Cmax,para
timeFrame: 0-5h after standardised meal, Day 141
measure: tmax,para
timeFrame: 0-5h after standardised meal, Day 141
measure: Mean postprandial rating - hunger
timeFrame: Day 140
measure: Mean postprandial rating - fullness
timeFrame: Day 140
measure: Mean postprandial rating - satiety
timeFrame: Day 140
measure: Mean postprandial rating - prospective food consumption
timeFrame: Day 140
measure: Mean postprandial rating - overall appetite score (OAS)
timeFrame: Day 140
measure: Food cravings assessed by Control of Eating Questionnaire (COEQ)
timeFrame: Day 139
measure: AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state
timeFrame: Day 140 to 141
measure: Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg
timeFrame: Day 140 to 175
measure: tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg
timeFrame: Day 140 to 175
measure: t½,sema,50mg,SS terminal half-life of the log concentration time curve
timeFrame: Day 140 to 175
measure: CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state
timeFrame: Day 140 to 175
measure: Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state
timeFrame: Day 140 to 175
measure: Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg
timeFrame: Day 140 to 175
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
citation: Gabe MBN, Breitschaft A, Knop FK, Hansen MR, Kirkeby K, Rathor N, Adrian CL. Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31.