Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis

NCT05064735 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: NN9536-4578U1111-1246-58242020-000204-11
• Study Type: interventional
• Target: 407
• Locations: 11 countries
• Sites: 122

Brief Summary

This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants 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. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed. At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

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 68) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.

  Baseline (week 0), end of treatment (week 68)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

  WOMAC is a disease-specific patient-reported outcome measure designed to assess changes in symptoms and lower extremity functioning associated with treatment in patients with osteoarthritis of the hip and/or knee. WOMAC is a 24 item questionnaire which assesses clinically important, participant-relevant symptoms in area of pain, stiffness, and physical function in participants with osteoarthritis (OA). It consists of 3 subscales: pain, stiffness and physical function. The WOMAC raw pain score is derived as the sum of the 5 item scores in the pain domain. It will be normalised and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the raw score for the pain domain (i.e. 50) and multiplying by 100. Higher scores indicate worse outcome. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.

  Baseline (week 0), end of treatment (week 68)

Secondary Outcomes (23)

• Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)

  From baseline (week 0) to end of treatment (week 68)

• Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)

  From baseline (week 0) to end of treatment (week 68)

• Change in WOMAC Physical Function Score

  Baseline (week 0), end of treatment (week 68)

• Change in Short Form 36 (SF-36) Physical Functioning Score

  Baseline (week 0), end of treatment (week 68)

• Change in Waist Circumference

  Baseline (week 0), end of treatment (week 68)

Study Arms (2)

semaglutide 2.4 mg

EXPERIMENTAL

Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Drug: semaglutide 2.4 mg

semaglutide 2.4 mg (placebo)

PLACEBO COMPARATOR

Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Drug: semaglutide 2.4 mg (placebo)

Interventions

semaglutide 2.4 mg DRUG

semaglutide subcutaneous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

semaglutide 2.4 mg

semaglutide 2.4 mg (placebo) DRUG

semaglutide subcutanous (s.c.) 2.4 mg once-weekly or semaglutide placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

semaglutide 2.4 mg (placebo)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age above or equal to 18 years at the time of signing informed consent
• Body Mass Index (BMI) equal to or greater than 30.0 kg/m\^2
• Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg.
• Pain due to knee OA

You may not qualify if:

• Joint replacement in target knee
• Arthroscopy or injections into target knee within last 3 months prior to enrolment
• Any other joint disease in the target knee

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (122)

Baptist Health System

Montgomery, Alabama, 36106, United States

Location

Ortho Arizona

Phoenix, Arizona, 85018, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Stuart L. Silverman MD - A Medical Corporation

Beverly Hills, California, 90211, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Desert Oasis Hlthcr Med Group

Palm Springs, California, 92262, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research of Hollywood_Hollywood

Hollywood, Florida, 33024, United States

Location

Westside Center For Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States

Location

Well Pharma Medical Research Corp

Miami, Florida, 33143, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, 96814, United States

Location

Clinical Invest Special_Gurnee

Gurnee, Illinois, 60031, United States

Location

Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States

Location

Clinical Invest Special_Gurnee

Wauconda, Illinois, 60084, United States

Location

MediSphere Medical RC

Evansville, Indiana, 47714, United States

Location

Velocity Clin. Res Valparaiso

Valparaiso, Indiana, 46383, United States

Location

KU MedWest

Shawnee Mission, Kansas, 66217, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Maryland Veterans Administration Health Care System

Baltimore, Maryland, 21201, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075-6437, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

Location

Arcturus Healthcare, PLC.

Troy, Michigan, 48098, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

The Center For Pharmaceutical Research PC

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

NYU Langone Medical Cent-Joan H Tisch Cnt for Women's Health

New York, New York, 10010, United States

Location

Hospital For Special Surgery

New York, New York, 10021, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

DaVita Clinical Research - New York

The Bronx, New York, 10461, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

Great Lakes Medical Research

Westfield, New York, 14787, United States

Location

University of North Carolina- Chapel Hill Adults

Chapel Hill, North Carolina, 27517, United States

Location

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, 27405, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Raleigh Medical Group

Raleigh, North Carolina, 27609-7216, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Velocity Clin Res_Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Louis Stokes Clvlnd VA Med Ctr

Cleveland, Ohio, 44106-1702, United States

Location

Cleveland Clinic_Cleveland

Cleveland, Ohio, 44195, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Altoona Osteoporosis Center

Duncansville, Pennsylvania, 16635-8406, United States

Location

The University of Penn Center

Philadelphia, Pennsylvania, 19104-3317, United States

Location

Parkside Family Medicine

Philadelphia, Pennsylvania, 19144, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Accellacare US Inc._SC

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Carolina Res Ctr.

North Charleston, South Carolina, 29405, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Tennova HC Turkey Creek MC

Knoxville, Tennessee, 37934, United States

Location

PrimeCare Medical Group

Houston, Texas, 77024, United States

Location

Southwest Houston Research Ltd

Houston, Texas, 77099, United States

Location

DM Clin Rsrch/Fam Diag Clinic

Tomball, Texas, 77375, United States

Location

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

Location

National Clin Res Inc.

Richmond, Virginia, 23294, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

C-endo Diab Endo Clin Calgery

Calgary, Alberta, T2V 4J2, Canada

Location

C-endo Diab & Endo Clinic

Edmonton, Alberta, T6H 2L4, Canada

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Commonwealth Medical Clinic

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

Location

Manna Research Inc. (Burlington N)

Burlington, Ontario, L7M 4Y1, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8M 1K7, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Dr Anil K Gupta Med Prof Corp

Toronto, Ontario, M9V 4B4, Canada

Location

Manna Research Inc._Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1J 1Z4, Canada

Location

Ctr Méd. et pro d l'Ost d port

Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada

Location

Institut universitaire de cardiologie

Québec, G1V 4G5, Canada

Location

Master Centre for Canada

Toronto, M5V 3L9, Canada

Location

Centro de investigación médico asistencial S.A.S

Barranquilla, 80020, Colombia

Location

BLUECARE SALUD S.A.S. Sede Centro Médico Integral

Bogotá, 110221, Colombia

Location

CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas

Bogotá, 110221, Colombia

Location

Preventive Care S.A.S

Chía, 250001, Colombia

Location

Klinik for Led og bindevævssygdomme

Aarhus N, 8200, Denmark

Location

Frederiksberg Hospital - Parker Institutet (Artrose)

Frederiksberg, 2000, Denmark

Location

Centre Hospitalier de Clermont-Ferrand-Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2

Le Creusot, 71200, France

Location

Aphp-Hopital La Pitie Salpetriere-3

Paris, 75651, France

Location

CHU Pitié-Salpétrière

Paris, 75651, France

Location

Ap-Hp-Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Hospices Civils de Lyon-Hopital Lyon Sud-1

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

Toulouse, 31054, France

Location

Centre de Recherche Clinique Portes Du Sud

Vénissieux, 69200, France

Location

Akershus Universitetssykehus

Nordbyhagen, 1474, Norway

Location

Oslo us HF, Aker sykehus

Oslo, 0586, Norway

Location

Senter for sykelig overvekt i Helse Sør-Øst

Tønsberg, 3117, Norway

Location

PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways

Kazan', 420061, Russia

Location

LLC Medical center "Maksimum Zdorovia"

Kemerovo, 650066, Russia

Location

FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

Moscow, 117292, Russia

Location

Setchenov First Moscow State Medical University

Moscow, 119435, Russia

Location

Federal Bureau for Medical and Social Expertise

Moscow, 127486, Russia

Location

Consultative & Diagnostic Center with a Outpatient Hospital

Saint Petersburg, 197110, Russia

Location

SIH "Saratov Regional Clinical Hospital for War Veterans"

Saratov, 410002, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Voronezh Regional Clinical Consultive-diagnostic Centre

Voronezh, 394018, Russia

Location

SBCI HC Yaroslavl region "Central City Hospital"

Yaroslavl, 150047, Russia

Location

King Abdulaziz Hospital-Al Ahsa-National Guard

Al Ahsa, 36428, Saudi Arabia

Location

King Khaled University Hospital,King Saud Univ. Med. City

Riyadh, 12372, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Centre, Riyadh

Riyadh, 12713, Saudi Arabia

Location

King Fahad Medical City

Riyadh, 21451, Saudi Arabia

Location

Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

Dr Wilhase's rooms

Boksburg, Gauteng, 1466, South Africa

Location

Chris Hani Baragwanath Hospital

Johannesburg, Gauteng, 2013, South Africa

Location

Botho ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa

Location

Dr J Reddy

Durban, KwaZulu-Natal, 4450, South Africa

Location

Lenmed Shifa Private Hospital

Durban, KwaZulu-Natal, 4901, South Africa

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

Location

Forskningsmottagning Internmedicin (tidigare KFE)

Malmo, 205 02, Sweden

Location

Medicinkliniken Överviktsenheten USÖ

Örebro, 701 85, Sweden

Location

S:t Göran Sjukhus

Stockholm, 112 81, Sweden

Location

Department of Metabolism and Endocrinology

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• Bliddal H, Bays H, Czernichow S, Udden Hemmingsson J, Hjelmesaeth J, Hoffmann Morville T, Koroleva A, Skov Neergaard J, Velez Sanchez P, Wharton S, Wizert A, Kristensen LE; STEP 9 Study Group. Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1573-1583. doi: 10.1056/NEJMoa2403664.

  PMID: 39476339 RESULT

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 1, 2021
• Primary Completion: July 24, 2023
• Study Completion: September 8, 2023
• Last Updated: November 17, 2025
• Results First Posted: August 13, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

RU (10); FR (9); CA (16); SE (4); SA (4); ES (3); US (61); ZA (6); DK (2); NO (3); CO (4)