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NCT05035095 · ClinicalTrials.gov registry record · Phase 3
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
A Phase 3 study of Obesity and Overweight, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 667
- Enrollment target
- 20
- Study locations
NCT05035095: Completed Phase 3 study of Obesity and Overweight, sponsored by Novo Nordisk A/S.
NCT05035095 is a Phase 3 study of Obesity and Overweight that has completed, run by Novo Nordisk A/S. The registered enrollment target is 667 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05035095, a Phase 3 study of Obesity and Overweight, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 667 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
Primary Outcome
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Conditions Studied
Interventions
- DRUG Placebo (semaglutide)
- DRUG Oral semaglutide
Study Locations (20)
Florida
- The Chappel Group Research - Kissimmee
- Clinical Trial Res Assoc,Inc - Plantation
Virginia
- Washington Cntr Weight Mgmt - Arlington
- Selma Medical Associates - Winchester
Ontario
- Wharton Med Clin Trials - Hamilton
- Premier Clinical Trial Research Network (PCTRN) - Hamilton
Other
- Center for Klinisk Metabolisk Forskning - Hellerup
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159 - Hvidovre
Alabama
- Univ of Alabama Birmingham - Birmingham
California
- Velocity Clin Res Los Angeles - Los Angeles
Hawaii
- East West Med Res Inst - Honolulu
Indiana
- Midwest Inst For Clin Res - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 3 |
What the finished NCT05035095 record still lists
NCT05035095 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (18% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo (semaglutide) is the first listed.
NCT05035095 names 20 study sites across 16 states, led by Florida, Virginia, Ontario.
Frequently Asked Questions
What is clinical trial NCT05035095 about?
NCT05035095 is a clinical study titled "Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)". This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('d...
What is the current status of trial NCT05035095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2021-09-13. Estimated completion is 2023-05-12.
What conditions does trial NCT05035095 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT05035095?
The interventions under investigation include: Placebo (semaglutide) (DRUG), Oral semaglutide (DRUG).
Who is sponsoring clinical trial NCT05035095?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05035095 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Hawaii, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05035095's enrollment target sits among peer trials
667 111th of 1053 higher than 943 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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