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Glucagon-like peptide-1 receptor agonist

Semaglutide for Obesity (STEP-HFpEF 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 Trial Summary

This trial is to study the effect of semaglutide, a new medicine, on people with heart failure as well as their body weight. Participants will be randomly assigned to either take semaglutide or a placebo and will be monitored for 59 weeks. There will be 11 clinic visits and 1 phone call with the study doctor.

Eligible Conditions

Obesity

STEP-HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week -2) to end of treatment (week 52)

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 C-Reactive Protein (CRP)

Change in KCCQ overall summary score

Change in six-minute walking distance

+16 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

STEP-HFpEF Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.

Group II: Placebo (semaglutide)Placebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2019

Completed Phase 4

~5160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,513 Previous Clinical Trials

2,414,500 Total Patients Enrolled

141 Trials studying Obesity

131,509 Patients Enrolled for Obesity

Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S

56 Previous Clinical Trials

44,591 Total Patients Enrolled

10 Trials studying Obesity

17,849 Patients Enrolled for Obesity

Frequently Asked Questions

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

What are the most significant findings from previous trials of Semaglutide?

"Presently, there are 59 active clinical trials investigating Semaglutide. Of these, 27 are Phase 3 trials. Most of the research is being conducted out of Loma Linda, California; though, there are 3696 total research sites for Semaglutide."

Answered by AI

What other research exists in this area?

"Semaglutide has been researched since 2018. The first clinical trial, sponsored by Novo Nordisk A/S, took place that year and involved 1387 patients. Phase 4 drug approval was granted after the successful first trial and, as of now, 59 active trials for Semaglutide are being conducted in 711 cities and 55 countries."

Answered by AI

Are people with the qualifying illness able to sign up for this study?

"No, this trial is not recruiting at the moment. It was last updated on September 20th, 2022, after being posted on March 16th, 2021. However, there are 1,766 other trials that are currently looking for patients."

Answered by AI

What is the primary reason that Semaglutide is prescribed?

"Semaglutide is most often used to help people manage their weight over the long term. However, it can also be given to patients that are following a reduced-calorie diet and exercising regularly to help treat other conditions like obesity-related comorbidities."

Answered by AI

Has Semaglutide received formal approval from the FDA?

"Semaglutide is rated a 3 in terms of safety by our Power team. This is due to the fact that it is a Phase 3 trial, supporting the efficacy of the drug and that there is reliable data to suggest that it is safe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04788511.