Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Obesity

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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. T...

Eligibility Criteria

Inclusion

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to 30.0 kg/m\^2
  • New York Heart Association (NYHA) Class II-IV
  • Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening

Exclusion

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening

Key Trial Info

Start Date :

March 16 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 18 2023

Estimated Enrollment :

529 Patients enrolled

Trial Details

Trial ID

NCT04788511

Start Date

March 16 2021

End Date

April 18 2023

Last Update

December 5 2025

Active Locations (146)

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Page 1 of 37 (146 locations)

1

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States, 36532

2

National Heart Institute Cal

Beverly Hills, California, United States, 90211

3

Keck Medical Center of USC - Outpatient Clinic

Los Angeles, California, United States, 90033

4

Lundquist Inst-Biomed Innovtn

Torrance, California, United States, 90502