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Glucagon-like peptide-1 receptor agonist

Semaglutide for Heart Failure (STEP HFpEF DM Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week -2) to end of treatment (week 52)
Awards & highlights

STEP HFpEF DM Trial Summary

This trial is testing a new medication, semaglutide, to see if it helps with heart failure symptoms and weight loss. Participants will take an injection once a week for just over a year, and have 12 clinic visits with the study doctor.

Eligible Conditions
  • Diabetic Heart Failure With Preserved Ejection Fraction (HFpEF)

STEP HFpEF DM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week -2) to end of treatment (week 52)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -2) to end of treatment (week 52) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Change in body weight
Secondary outcome measures
Change in 6-minute walking distance
Change in C-Reactive Protein
Change in KCCQ overall summary score
+18 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

STEP HFpEF DM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 2.4 mg once weekly (OW)Experimental Treatment1 Intervention
Participants will receive semaglutide injections for 52 weeks.
Group II: Semaglutide placebo OWPlacebo Group1 Intervention
Participants will receive semaglutide placebo injections for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,419 Total Patients Enrolled
8 Trials studying Heart Failure
29,433 Patients Enrolled for Heart Failure
Clinical Transparency (Dept.1452)Study DirectorNovo Nordisk A/S
3 Previous Clinical Trials
153 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04916470 — Phase 3
Heart Failure Research Study Groups: Semaglutide 2.4 mg once weekly (OW), Semaglutide placebo OW
Heart Failure Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT04916470 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04916470 — Phase 3
Heart Failure Patient Testimony for trial: Trial Name: NCT04916470 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research unique or has it been conducted before?

"Semaglutide has 58 live clinical trials in 712 cities across 55 countries. The first study was sponsored by Novo Nordisk A/S in 2018 and involved 1387 patients. The study completed its Phase 4 drug approval stage and, since then, 124 similar studies have been completed."

Answered by AI

What other drugs has Semaglutide been tested against in previous clinical trials?

"58 different clinical trials are currently underway to study Semaglutide. The majority of these trials are in their third phase of study. The primary location for these trials is Loma Linda, CA, but there are 3702 total sites for these trials."

Answered by AI

Has the FDA cleared Semaglutide for use?

"Semaglutide has undergone Phase 3 clinical trials, thus there is some evidence of both efficacy and safety. Based on this, our team has given Semaglutide a safety rating of 3."

Answered by AI

What are the primary conditions that Semaglutide is meant to address?

"Semaglutide is frequently used to help manage chronic weight, but it can also be given as a treatment for other conditions like reduced-calorie diet, exercise, and at least one weight-related comorbid condition."

Answered by AI

If a patient were to choose this clinical trial, would they have to travel to a different city?

"To make participation more convenient for enrollees, this clinical trial has 26 sites. Some of these sites are in Jacksonville, Scarborough and Rochester, with the remaining locations being dispersed throughout the country."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
California
Mississippi
Other
How old are they?
18 - 65
65+
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Would like to see if this can help me and others. i want to help other people with the same problems i have.
PatientReceived 1 prior treatment
I have morbid obesity and diabetes with out having to use any medication. I have been seeing a doctor for two years and have been on medication, off and on to.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What is Phase 3?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
2021. "Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04916470.
~159 spots leftby Apr 2025
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