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NCT03611582 · ClinicalTrials.gov registry record · Phase 3

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

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

Completed
Registry status
Phase 3
Development phase
611
Enrollment target

NCT03611582 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 611 participants.

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The verdict

NCT03611582, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
611 participants
Enrollment target

Study Summary

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant 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, thigh or upper arm. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.

Interventions

  • DRUG Semaglutide
  • DRUG Placebo (semaglutide)

Trial Details

FieldValue
Enrollment Target 611 participants
Start Date 2018-08-01
Est. Completion 2020-04-28
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT03611582

The ClinicalTrials.gov registry entry for NCT03611582 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 611 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.

NCT03611582 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03611582 about?

NCT03611582 is a clinical study titled "Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program". This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an i...

What is the current status of trial NCT03611582?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 611 participants. The study started on 2018-08-01. Estimated completion is 2020-04-28.

What interventions are being tested in trial NCT03611582?

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

Who is sponsoring clinical trial NCT03611582?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.