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NCT03548935 · ClinicalTrials.gov registry record · Phase 3
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,961
- Enrollment target
NCT03548935 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,961 participants.
The verdict
NCT03548935, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,961 participants
- Enrollment target
Study Summary
This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. 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, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
Interventions
- DRUG Semaglutide
- DRUG Placebo (semaglutide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,961 participants |
| Start Date | 2018-06-04 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03548935
The ClinicalTrials.gov registry entry for NCT03548935 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,961 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.
NCT03548935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03548935 about?
NCT03548935 is a clinical study titled "STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity". This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants wi...
What is the current status of trial NCT03548935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,961 participants. The study started on 2018-06-04. Estimated completion is 2021-03-05.
What interventions are being tested in trial NCT03548935?
The interventions under investigation include: Semaglutide (DRUG), Placebo (semaglutide) (DRUG).
Who is sponsoring clinical trial NCT03548935?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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