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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: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT03611582 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 611 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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 periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (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 (week
Interventions
- DRUG Semaglutide
- DRUG Placebo (semaglutide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-04-28 |
| Phase | Phase 3 |
What the finished NCT03611582 record still lists
NCT03611582 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Semaglutide is the first listed.
NCT03611582 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03611582's enrollment target sits among peer trials
611 600th of 2000 higher than 1,400 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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