CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 207 enrolled
Drug / intervention
Semaglutide 2.4 mg +1 moredrug
Likely dose
Semaglutide 2.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05040971
NCT05040971Phase 3Completed

Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes

Novo Nordisk A/S·interventional·Posted Sep 10, 2021·Updated Jan 29, 2026

In Brief

A Phase 3 clinical trial evaluating Semaglutide 2.4 mg and Placebo for Obesity. Completed, enrolled 207 participants across 43 sites in 5 countries.

Detailed Summary

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesCanada, Denmark, Finland, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedSep 10, 2021
Enrollment StartSep 6, 2021
Primary CompletionJan 6, 2023
Study CompletionJul 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.8 years ago

Interventions

Semaglutide 2.4 mgdrug

Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg

Placebodrug

Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week