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

Last updated: November 10, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Osteoarthritis

Diabetes Prevention

Treatment

semaglutide 2.4 mg

semaglutide 2.4 mg (placebo)

Clinical Study ID

NCT05064735
NN9536-4578
2020-000204-11
U1111-1246-5824
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informedconsent

  • 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) withmoderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per centralreading) in target knee. Target knee joint is defined as most symptomatic knee atscreening. If pain in knees are equal target knee joint will be in the most dominantleg.

  • Pain due to knee OA

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 407
Treatment Group(s): 2
Primary Treatment: semaglutide 2.4 mg
Phase: 3
Study Start date:
October 01, 2021
Estimated Completion Date:
September 08, 2023

Connect with a study center

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Ocean West Research Clinic

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Hamilton Med Res Group

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Milestone Research

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Dr. Anil K Gupta Medicine Professional Corporation

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Centre Medical Acadie

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Centro de investigación médico asistencial S.A.S

    Barranquilla, 80020
    Colombia

    Site Not Available

  • Novo Nordisk Investigational Site

    Barranquilla, 80020
    Colombia

    Site Not Available

  • CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas

    Bogota, 110221
    Colombia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bogota, 110221
    Colombia

    Site Not Available

  • Novo Nordisk Investigational Site

    Chia, 250001
    Colombia

    Site Not Available

  • Preventive Care S.A.S

    Chia, 250001
    Colombia

    Site Not Available

  • Klinik for Led og bindevævssygdomme

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Frederiksberg Hospital - Parker Institutet (Artrose)

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Centre Hospitalier de Clermont-Ferrand-Hopital Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Aphp-Hopital La Pitie Salpetriere-3

    PARIS cedex 13, 75651
    France

    Site Not Available

  • CHU Pitié-Salpétrière

    PARIS cedex 13, 75651
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    PARIS cedex 13, 75651
    France

    Site Not Available

  • Ap-Hp-Hopital Europeen Georges Pompidou

    Paris, 75908
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75908
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris, 75908
    France

    Site Not Available

  • Hospices Civils de Lyon-Hopital Lyon Sud-1

    Pierre Benite, 69310
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pierre Benite, 69310
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    TOULOUSE cedex, 31054
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Toulouse, 31054
    France

    Site Not Available

  • Akershus Universitetssykehus

    Nordbyhagen, 1474
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Nordbyhagen, 1474
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Oslo, 0586
    Norway

    Site Not Available

  • Oslo us HF, Aker sykehus

    Oslo, 0586
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Tønsberg, 3117
    Norway

    Site Not Available

  • Senter for sykelig overvekt i Helse Sør-Øst

    Tønsberg, 3117
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420061
    Russian Federation

    Site Not Available

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

    Kazan, 420061
    Russian Federation

    Site Not Available

  • LLC Medical center "Maksimum Zdorovia"

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Federal Bureau for Medical and Social Expertise

    Moscow, 127486
    Russian Federation

    Site Not Available

  • National Medical Research Center of Endocrinology

    Moscow, 117292
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 117292
    Russian Federation

    Site Not Available

  • Setchenov First Moscow State Medical University

    Moscow, 119435
    Russian Federation

    Site Not Available

  • Consultative & Diagnostic Center with a Outpatient Hospital

    Saint-Petersburg, 197110
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 197110
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saratov, 410002
    Russian Federation

    Site Not Available

  • SIH "Saratov Regional Clinical Hospital for War Veterans"

    Saratov, 410002
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Siberian State Medical University

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Voronezh Regional Clinical Consultive-diagnostic Centre

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Vorornezh Regional Clinical Consultive-diagnostic Centre

    Voronezh, 394018
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Yaroslavl, 150047
    Russian Federation

    Site Not Available

  • SBCI HC Yaroslavl region "Central City Hospital"

    Yaroslavl, 150047
    Russian Federation

    Site Not Available

  • King Abdulaziz Hospital-Al Ahsa-National Guard

    Al Ahsa, 36428
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Al Ahsa, 36428
    Saudi Arabia

    Site Not Available

  • King Fahad Medical City

    Riyadh, 21451
    Saudi Arabia

    Site Not Available

  • King Faisal Specialist Hospital & Research Centre, Riyadh

    Riyadh, 12713
    Saudi Arabia

    Site Not Available

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

    Riyadh, 12372
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Riyadh, 21451
    Saudi Arabia

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Site Not Available

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Site Not Available

  • Dr Wilhase's rooms

    Boksburg, Gauteng 1466
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Boksburg, Gauteng 1466
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Botho ke Bontle Health Services

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Dr J Reddy

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Maxwell Centre

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Stanger, Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña

    La Coruña, 15006
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    La Coruña, 15006
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Sevilla, 41003
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Sevilla, 41003
    Spain

    Site Not Available

  • Forskningsmottagning Internmedicin (tidigare KFE)

    Malmö, 205 02
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Malmö, 205 02
    Sweden

    Site Not Available

  • Department of Metabolism and Endocrinology

    Stockholm, 141 86
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Stockholm, 112 81
    Sweden

    Site Not Available

  • S:t Göran Sjukhus

    Stockholm, 112 81
    Sweden

    Site Not Available

  • Medicinkliniken Överviktsenheten USÖ

    Örebro, 701 85
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Örebro, 701 85
    Sweden

    Site Not Available

  • Baptist Health System

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Springs, California 92262
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Westside Center For Clinical Research

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ocala, Florida 34470
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • East West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evanston, Illinois 60201-2477
    United States

    Site Not Available

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Evanston Premier Hlthcr Res

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Arcturus Healthcare, PLC.

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Sundance Clinical Research LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Southgate Medical Group, LLP

    West Seneca, New York 14224
    United States

    Site Not Available

  • Great Lakes Medical Research

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westfield, New York 14787
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Cleveland Clinic_Cleveland

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Prestige Clinical Research

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Coastal Carolina Res Ctr.

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77024
    United States

    Site Not Available

  • PrimeCare Medical Group

    Houston, Texas 77024
    United States

    Site Not Available

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Site Not Available

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