A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

NCT05236517 | Completed Phase 1

• 3 other identifiers: NN9932-48732021-003341-38U1111-1266-4375
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in energy intake during ad libitum lunch

  Measured in Percentage

  Baseline to Day 140

Secondary Outcomes (20)

• Change in energy intake during ad libitum lunch

  Baseline to Day 140

• Change in amount of food consumed during ad libitum lunch

  Baseline to Day 140

• Change in body weight

  Baseline to Day 141

• AUC0-5h,para

  0-5h after standardised meal, Day 141

• AUC0-1h,para

  0-1h after standardised meal, Day 141

Study Arms (2)

Semaglutide

EXPERIMENTAL

Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide D Dose 3; Drug: Semaglutide C Dose 4; Drug: Semaglutide C Dose 5 (50 mg)

Placebo

PLACEBO COMPARATOR

Drug: Placebo (Semaglutide C); Drug: Placebo ( Semaglutide D)

Interventions

Semaglutide D Dose 1 DRUG

Tablet given orally

Semaglutide

Semaglutide D Dose 2 DRUG

Tablet given orally

Semaglutide

Semaglutide D Dose 3 DRUG

Tablet given orally

Semaglutide

Semaglutide C Dose 4 DRUG

Tablet given orally

Semaglutide

Semaglutide C Dose 5 (50 mg) DRUG

Tablet given orally

Semaglutide

Placebo (Semaglutide C) DRUG

Tablet given orally

Placebo

Placebo ( Semaglutide D) DRUG

Tablet given orally

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

Related Publications (1)

• 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.

  PMID: 39082206 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 11, 2022
• Study Start: February 8, 2022
• Primary Completion: September 29, 2022
• Study Completion: November 7, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)