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COMPLETED 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)

NCT05035095 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 667 participants
Start Date 2021-09-13
Est. Completion 2023-05-12
Phase Phase 3

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05035095

The ClinicalTrials.gov registry entry for NCT05035095 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 667 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 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05035095 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, Virginia, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05035095?

The interventions under investigation include: Placebo (semaglutide) (DRUG), Oral semaglutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05035095?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial