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Semaglutide

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Completed PHASE3 INTERVENTIONAL NCT04788511

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. 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 choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Interventions

Name: Semaglutide

Type: DRUG

Description: Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.

Name: Placebo (semaglutide)

Type: DRUG

Description: Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. The study will last for approximately 59 weeks.

Primary Outcomes

Measure: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)

TimeFrame: From baseline (week 0) to end of treatment (week 52)

Description: The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.

Measure: Change in Body Weight

TimeFrame: From baseline (week 0) to end of treatment (week 52)

Description: Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.

Trial Information

NCT ID

NCT04788511

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025