Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

• Status: Not yet recruiting
• Trial end date: 2024-05-14
• Target enrollment: 0
• Participant gender: All

Summary

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study

• Male or female, age greater than or equal to 18 years at the time of signing informed consent

• Body mass index (BMI) of

• Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR

• Greater than or equal to 30.0 kg/m^2

• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

• A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records

• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening