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Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

NCT04916470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Interventions

DRUG

Semaglutide

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.

DRUG

Placebo (Semaglutide)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept.1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-10-11
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916470 on ClinicalTrials.gov