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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: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT05646706 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,407 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
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 |
What the finished NCT05646706 record still lists
NCT05646706 is an interventional study that assigns participants to a tested intervention. Its 1,407 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05646706 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05646706's enrollment target sits among peer trials
1,407 171st of 2000 higher than 1,829 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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