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NCT05646706 · ClinicalTrials.gov registry record · Phase 3
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,407
- Enrollment target
NCT05646706 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,407 participants.
The verdict
NCT05646706, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,407 participants
- Enrollment target
Study Summary
This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
Interventions
- DRUG Placebo
- DRUG Semaglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,407 participants |
| Start Date | 2023-01-04 |
| Est. Completion | 2024-11-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05646706
The ClinicalTrials.gov registry entry for NCT05646706 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,407 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 Placebo is the first listed.
NCT05646706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05646706 about?
NCT05646706 is a clinical study titled "A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)". This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In additio...
What is the current status of trial NCT05646706?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,407 participants. The study started on 2023-01-04. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT05646706?
The interventions under investigation include: Placebo (DRUG), Semaglutide (DRUG).
Who is sponsoring clinical trial NCT05646706?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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