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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: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT03548935 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,961 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (154% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (w
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 |
What the finished NCT03548935 record still lists
NCT03548935 is an interventional study that assigns participants to a tested intervention. Its 1,961 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 (154% higher).
The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.
NCT03548935 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03548935's enrollment target sits among peer trials
1,961 107th of 2000 higher than 1,894 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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