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

NCT05564117 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: NN9932-4954U1111-1271-90562021-006534-40
• Study Type: interventional
• Target: 307
• Locations: 4 countries
• Sites: 23

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

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Body Weight

  Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.

  Baseline (week 0), end of treatment (week 64)

• Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

  Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

  At end of treatment (week 64)

Secondary Outcomes (25)

• Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

  At end of treatment (week 64)

• Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

  At end of treatment (week 64)

• Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

  At end of treatment (week 64)

• Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)

  Baseline (week 0), end of treatment (week 64)

• Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)

  Baseline (week 0), end of treatment (week 64)

Study Arms (2)

Oral semaglutide 25 mg

EXPERIMENTAL

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).

Drug: Semaglutide

Oral semaglutide placebo

PLACEBO COMPARATOR

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

Drug: Placebo semaglutide

Interventions

Semaglutide DRUG

Semaglutide tablets orally once daily for 64 weeks.

Oral semaglutide 25 mg

Placebo semaglutide DRUG

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

Oral semaglutide placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (23)

Univsty Of AL At Birmingham

Birmingham, Alabama, 35294, United States

Location

FDRC

Costa Mesa, California, 92627, United States

Location

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, 96814, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601, United States

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

Lingen, 49808, Germany

Location

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, 48153, Germany

Location

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

Location

Praxis Dr. med. Wenzl-Bauer

Rehlingen-Siersburg, 66780, Germany

Location

MZM Praxis Drs. Erlinger

Stuttgart, 70378, Germany

Location

Praxis für Prävention und Therapie, Drs Jacob

Villingen-Schwenningen, 78048, Germany

Location

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany

Location

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

Legnica, Lower Silesian Voivodeship, 59-220, Poland

Location

ETG Lublin

Lublin, Lublin Voivodeship, 20-412, Poland

Location

ETG Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

ETG Warszawa Sp. z o.o.

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, Podlaskie Voivodeship, 15-281, Poland

Location

Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, 60-589, Poland

Location

Related Publications (1)

• 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.

  PMID: 40934115 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: October 11, 2022
• Primary Completion: April 18, 2024
• Study Completion: May 7, 2024
• Last Updated: February 25, 2026
• Results First Posted: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (6); DE (8); CA (2); US (7)