CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 617 enrolled
Drug / intervention
Semaglutide +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/NCT04916470
NCT04916470Phase 3Completed

Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Jun 7, 2021·Updated Nov 26, 2025

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo (Semaglutide) for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2. Completed, enrolled 617 participants across 180 sites in 16 countries.

Detailed Summary

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. 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 area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. * At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study 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--
CountriesArgentina, Austria, Canada, Czechia, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 7, 2021
Enrollment StartJun 15, 2021
Primary CompletionOct 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.1 years ago

Interventions

Semaglutidedrug

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.

Placebo (Semaglutide)drug

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.