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NCT04788511 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Obesity, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
529
Enrollment target
20
Study locations

NCT04788511: Completed Phase 3 study of Obesity, sponsored by Novo Nordisk A/S.

NCT04788511 is a Phase 3 study of Obesity that has completed, run by Novo Nordisk A/S. The registered enrollment target is 529 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04788511, a Phase 3 study of Obesity, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
529 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Semaglutide
  • DRUG Placebo (semaglutide)

Study Locations (20)

Illinois

  • Endeavor Health Clinical Operations-NCH - Arlington Heights
  • University of Chicago Medicine - Chicago
  • Endeavor Health Glenbook Hosp - Evanston
  • Northwestern University_Chicago_0 - Evanston
  • Chicago Medical Research LLC - Hazel Crest

Florida

  • Jacksonville Ctr For Clin Res - Jacksonville
  • First Coast Cardiovascular Institute - Jacksonville
  • Baptist Heart Specialists_Jacksonville - Jacksonville
  • CV Res Ctr of S Florida - Miami

California

  • National Heart Institute Cal - Beverly Hills
  • Keck Medical Center of USC - Outpatient Clinic - Los Angeles
  • Lundquist Inst-Biomed Innovtn - Torrance

Kentucky

  • The Research Group of Lexington LLC - Lexington
  • Baptist Health Louisville - Louisville
  • Baptist Health Madisonville, Inc - Madisonville

Kansas

  • University of Kansas Medical Center_Kansas City - Kansas City
  • Cotton-O'Neil Heart Center - Topeka

Alabama

  • Eastern Shore Rsrch Inst, LLC - Fairhope

Indiana

  • Ascension St. Vincent Medical Group - Indianapolis

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 529 participants
Start Date 2021-03-16
Est. Completion 2023-04-18
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT04788511 record still lists

NCT04788511 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (35% lower).

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide is the first listed.

NCT04788511 names 20 study sites across 8 states, led by Illinois, Florida, California.

Frequently Asked Questions

What is clinical trial NCT04788511 about?

NCT04788511 is a clinical study titled "Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity". 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 semagluti...

What is the current status of trial NCT04788511?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2021-03-16. Estimated completion is 2023-04-18.

What conditions does trial NCT04788511 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT04788511?

The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).

Who is sponsoring clinical trial NCT04788511?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04788511 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04788511's enrollment target sits among peer trials

529 129th of 1053 higher than 925 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04788511, the US trial registry maintained by the National Library of Medicine. NCT04788511 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.