Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

NCT ID: NCT05564117

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2024-05-07

Brief Summary

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral semaglutide 25 mg

Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Semaglutide tablets orally once daily for 64 weeks.

Oral semaglutide placebo

Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo semaglutide

Intervention Type: DRUG

Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Interventions

Semaglutide

Semaglutide tablets orally once daily for 64 weeks.

Intervention Type: DRUG

Placebo semaglutide

Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
• Male or female, age greater than or equal to 18 years at the time of signing informed consent
• Body mass index (BMI) of
• Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
• Greater than or equal to 30.0 kg/m^2
• History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria

• A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Univsty Of AL At Birmingham

Birmingham, Alabama, United States

FDRC

Costa Mesa, California, United States

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, United States

Accellacare

Wilmington, North Carolina, United States

UT Southwestern Med Cntr

Dallas, Texas, United States

Washington Cntr Weight Mgmt

Arlington, Virginia, United States

Selma Medical Associates

Winchester, Virginia, United States

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Wharton Med Clin Trials

Hamilton, Ontario, Canada

InnoDiab Forschung GmbH

Essen, , Germany

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

Lingen, , Germany

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, , Germany

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, , Germany

Praxis Dr. med. Wenzl-Bauer

Rehlingen-Siersburg, , Germany

MZM Praxis Drs. Erlinger

Stuttgart, , Germany

Jacob, Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, , Germany

Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.

Legnica, Lower Silesian Voivodeship, Poland

ETG Lublin

Lublin, Lublin Voivodeship, Poland

ETG Siedlce

Siedlce, Masovian Voivodeship, Poland

ETG Warszawa Sp. z o.o.

Warsaw, Masovian Voivodeship, Poland

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, Podlaskie Voivodeship, Poland

Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, Poland

Countries

United States; Canada; Germany; Poland

References

Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969.

Reference Type: DERIVED

PMID: 40934115 (View on PubMed)

Other Identifiers

U1111-1271-9056

Identifier Type: OTHER

Identifier Source: secondary_id

2021-006534-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9932-4954

Identifier Type: -

Identifier Source: org_study_id