Clinical trial NCT05064735: Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
Official title: Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 407
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Percentage Change in Body Weight
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
timeFrame: Baseline (week 0), end of treatment (week 68)
Secondary outcomes:
measure: Percentage of Participants Achieving Body Weight Reduction Greater Than or Equal to (≥) 5 Percent (%) (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Body Weight Reduction ≥ 10% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in WOMAC Physical Function Score
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in Short Form 36 (SF-36) Physical Functioning Score
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in Waist Circumference
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in WOMAC Stiffness Score
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in WOMAC Total Score
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in SF-36 Bodily Pain Score
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in SF-36 Physical Component Summary
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Change in SF-36 Mental Component Summary
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Percentage of Participants Using Allowed Rescue Analgesics During Wash Out (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Amount of Allowed Rescue Analgesics Used During Wash Out
timeFrame: At end of treatment (week 68)
measure: Percentage of Participants With Use of Pain Medication
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Pain Intensity (Numerical Rating Scale [NRS])
timeFrame: Baseline (week 0), end of treatment (week 68)
measure: Percentage of Participants Achieving Body Weight Reduction ≥ 15% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Body Weight Reduction ≥ 20% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving WOMAC Pain Reduction ≥ 30% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving WOMAC Pain Reduction ≥ 50% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Pain Score (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in WOMAC Physical Function Score (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participant Change in SF-36 Physical Functioning Score (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 30% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Percentage of Participants Achieving Pain Intensity (Numerical Rating Scale [NRS]) Reduction ≥ 50% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 68)
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Baptist Health System
state: Alabama
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Westside Center For Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Gurnee
country: United States
facility: Clinical Invest Special_Gurnee
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Troy
country: United States
facility: Arcturus Healthcare, PLC.
state: Michigan
city: Saint Louis
country: United States
facility: Sundance Clinical Research LLC
state: Missouri
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic_Cleveland
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Res Ctr.
state: South Carolina
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Research Network (PCTRN)
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Barranquilla
country: Colombia
facility: Centro de investigación médico asistencial S.A.S
city: Bogota
country: Colombia
facility: CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas
city: Chia
country: Colombia
facility: Preventive Care S.A.S
city: Aarhus N
country: Denmark
facility: Klinik for Led og bindevævssygdomme
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital - Parker Institutet (Artrose)
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier de Clermont-Ferrand-Hopital Gabriel Montpied
city: PARIS cedex 13
country: France
facility: Aphp-Hopital La Pitie Salpetriere-3
city: PARIS cedex 13
country: France
facility: CHU Pitié-Salpétrière
city: Paris
country: France
facility: Ap-Hp-Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon-Hopital Lyon Sud-1
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo us HF, Aker sykehus
city: Tønsberg
country: Norway
facility: Senter for sykelig overvekt i Helse Sør-Øst
city: Kazan
country: Russian Federation
facility: PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
city: Kemerovo
country: Russian Federation
facility: LLC Medical center "Maksimum Zdorovia"
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology
city: Moscow
country: Russian Federation
facility: Setchenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Federal Bureau for Medical and Social Expertise
city: Saint-Petersburg
country: Russian Federation
facility: Consultative & Diagnostic Center with a Outpatient Hospital
city: Saratov
country: Russian Federation
facility: SIH "Saratov Regional Clinical Hospital for War Veterans"
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultive-diagnostic Centre
city: Yaroslavl
country: Russian Federation
facility: SBCI HC Yaroslavl region "Central City Hospital"
city: Al Ahsa
country: Saudi Arabia
facility: King Abdulaziz Hospital-Al Ahsa-National Guard
city: Riyadh
country: Saudi Arabia
facility: King Khaled University Hospital,King Saud Univ. Med. City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre, Riyadh
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern Cape
city: Boksburg
country: South Africa
facility: Dr Wilhase's rooms
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho ke Bontle Health Services
state: Gauteng
city: Durban
country: South Africa
facility: Maxwell Centre
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr J Reddy
state: KwaZulu-Natal
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Malmö
country: Sweden
facility: Forskningsmottagning Internmedicin (tidigare KFE)
city: Stockholm
country: Sweden
facility: S:t Göran Sjukhus
city: Stockholm
country: Sweden
facility: Department of Metabolism and Endocrinology
city: Örebro
country: Sweden
facility: Medicinkliniken Överviktsenheten USÖ
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept. 2834)
role: STUDY_DIRECTOR
References:
citation: 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.